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TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a highly motivated Quality Engineer to join our organization! Founded in 1988, TOMZ continues to be a family owned and operated organization which offers competitive compensation and excellent benefits. Those include 401k, health/dental, vision, and paid time off. TOMZ maintains a modern, clean, and safe facility with state-of-the-art equipment and dedication to continuous process improvement. TOMZ is registered with the FDA as a Class 2 and Class 3 Medical Device Manufacturer and is certified to ISO 13485.

Summary of Position

This position will be responsible for the activities associated with Quality Design & Development (QD&D) Control and Assurance during Product Development Process (PDP) activities as well as continuation design & development support for sustaining manufacturing and product distribution.

Essential Functions

• Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
• Author and execute Quality Plans for Quality Product Design and Development projects.
• Initiate and/or consult in the development and/or update of Risk Management documentation in cooperation with cross-functional engineering teams per project requirements.
• Establish severity and risk-based Process Master Validation Plan strategies with appropriate V&V rationales.
• Support operational and process qualifications for customer manufacturing processes in cooperation with cross-functional engineering teams per project requirements.
• Drive Test Method development (w/ Operational and Business considerations) and execution of Test Method Validations to measure effectiveness.
• Provide direction in implementing Incoming, In-Process, and Final Product Inspection plans.
• Develop and justify appropriate sampling plans with characterization of test/inspection methods.
• Champion First Article Inspections and Component Qualifications.
• Represent Quality Engineering in design reviews throughout the process development process.
• Support initial qualification audit activities (Customer and Regulatory Agencies).
• Assist in qualification activities associated with supplier/vendor design characterization requirements for projects, to include audits and assessments.
• Support and enforce Quality Best Practices and GDP/GMP continuous improvement efforts.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Ensure compliance of all site personnel to site-level QMS and training requirements.
• May support the development of Quality Agreements for external customers.
• Other duties and responsibilities as assigned.

Qualifications:

Education

• Minimum 4-Year degree or equivalent of directly transferrable industry work experience (Engineering or Quality discipline preferred).

Experience

• Minimum of 4+ years of experience in a regulated manufacturing environment.

Preferred Skills/Qualifications

• Advanced Post-Secondary Education/Training/Certification coursework
• Quality certification(s) (e.g. ASQ CQE, QCI, etc.).
• Class I, II, and/or III Medical Device manufacturing experience.
• Regulated manufacturing industry experience (e.g. Aerospace, Defense, Pharmaceutical, etc.).
• Knowledge and experience with external standards:  ISO 900/9001, ISO 13485, and 21CFR 820, EU MDR, especially pertaining to product development, design controls, good manufacturing practices, supplier qualification, auditing, quality control (GD&T, Nonconforming Materials, MRB), Corrective and Preventive Actions, and customer complaints).
• Experience in effectively supporting audits by customers and external regulatory agencies.
• Strong verbal and written English language communication skills.
• Successfully meet TOMZ-specific positional/functional on-the-job training requirements.
• Competency with Microsoft Office (i.e. Outlook, Word, Excel, and PowerPoint).
• “Hands-on” self-starter with ability to work both independently and as part of a team.
• Ability to work with a variety of functional areas, including R&D, Manufacturing, and QA.

Physical Demands

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a highly motivated Quality Engineer to join our organization! Founded in 1988, TOMZ continues to be a family owned and operated organization which offers competitive compensation and excellent benefits. Those include 401k, health/dental, vision, and paid time off. TOMZ maintains a modern, clean, and safe facility with state-of-the-art equipment and dedication to continuous process improvement. TOMZ is registered with the FDA as a Class 2 and Class 3 Medical Device Manufacturer and is certified to ISO 13485.

Summary of Position

This position will be responsible for the activities associated with Quality Design & Development (QD&D) Control and Assurance during Product Development Process (PDP) activities as well as continuation design & development support for sustaining manufacturing and product distribution.

Essential Functions

• Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
• Author and execute Quality Plans for Quality Product Design and Development projects.
• Initiate and/or consult in the development and/or update of Risk Management documentation in cooperation with cross-functional engineering teams per project requirements.
• Establish severity and risk-based Process Master Validation Plan strategies with appropriate V&V rationales.
• Support operational and process qualifications for customer manufacturing processes in cooperation with cross-functional engineering teams per project requirements.
• Drive Test Method development (w/ Operational and Business considerations) and execution of Test Method Validations to measure effectiveness.
• Provide direction in implementing Incoming, In-Process, and Final Product Inspection plans.
• Develop and justify appropriate sampling plans with characterization of test/inspection methods.
• Champion First Article Inspections and Component Qualifications.
• Represent Quality Engineering in design reviews throughout the process development process.
• Support initial qualification audit activities (Customer and Regulatory Agencies).
• Assist in qualification activities associated with supplier/vendor design characterization requirements for projects, to include audits and assessments.
• Support and enforce Quality Best Practices and GDP/GMP continuous improvement efforts.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Ensure compliance of all site personnel to site-level QMS and training requirements.
• May support the development of Quality Agreements for external customers.
• Other duties and responsibilities as assigned.

Qualifications:

Education

• Minimum 4-Year degree or equivalent of directly transferrable industry work experience (Engineering or Quality discipline preferred).

Experience

• Minimum of 4+ years of experience in a regulated manufacturing environment.

Preferred Skills/Qualifications

• Advanced Post-Secondary Education/Training/Certification coursework
• Quality certification(s) (e.g. ASQ CQE, QCI, etc.).
• Class I, II, and/or III Medical Device manufacturing experience.
• Regulated manufacturing industry experience (e.g. Aerospace, Defense, Pharmaceutical, etc.).
• Knowledge and experience with external standards:  ISO 900/9001, ISO 13485, and 21CFR 820, EU MDR, especially pertaining to product development, design controls, good manufacturing practices, supplier qualification, auditing, quality control (GD&T, Nonconforming Materials, MRB), Corrective and Preventive Actions, and customer complaints).
• Experience in effectively supporting audits by customers and external regulatory agencies.
• Strong verbal and written English language communication skills.
• Successfully meet TOMZ-specific positional/functional on-the-job training requirements.
• Competency with Microsoft Office (i.e. Outlook, Word, Excel, and PowerPoint).
• “Hands-on” self-starter with ability to work both independently and as part of a team.
• Ability to work with a variety of functional areas, including R&D, Manufacturing, and QA.

Physical Demands

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a Senior Quality Engineer – Sustained Manufacturing to join our organization. TOMZ offers competitive compensation and excellent benefits, including 401k, health/dental, vision and paid time off. TOMZ maintains a modern, clean, and safe facility with state-of-the-art equipment and dedication to continuous process improvement. TOMZ is registered with the FDA as a Class 2 and Class 3 Medical Device Manufacturer and is certified to ISO 13485.

Summary of Position

This position will be responsible for the activities associated with Quality Sustained Manufacturing of commercial product and successful transfer of Development programs to standard production, through leadership, coaching and technical guidance of cross-functional Engineering teams.  This role will be expected to provide input on, and contribute to, development and implementation of Quality System improvement strategies and approaches. Faced paced work environment.

Essential Functions

• Initiate and/or consult in the development and/or update of Risk Management FMEA documentation in cooperation with cross-functional engineering teams per project requirements.
• Support operational and process qualifications for customer manufacturing processes in cooperation with cross-functional engineering teams.
• Provide direction in implementing and continuously improving Incoming Inspection, First Article Inspection, In-Process and Final Product Inspection plans.
• Ensure the continuous efficiency and improvement of Test/Inspection Methods
• Develop and justify appropriate sampling plans with characterization of test/inspection methods and acceptance criteria.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues, including CAPAs, Complaints and NCRs.
• Provide statistical data / trending analysis on Complaints, NCRs and other quality metrics to drive escalation and appropriate Corrective Actions to mitigate future recurrences of nonconformances.
• Conduct audits for internal manufacturing processes to ensure compliance with work instructions, summarize findings, outline opportunities for improvement, and proactively identify potential non-conformances.
• Assist in qualification activities associated with supplier/vendor design characterization requirements for projects, to include audits and assessments.
• Provide support for the compliance of Quality System support elements (QM 'feeder' systems) for the site QMS and the tracking & reporting of associated metrics as required.
• Support and enforce Quality Best Practices and GDP/GMP continuous improvement efforts.
• Support site customer-requested auditing activities (Customer and Regulatory Agencies).
• Ensure compliance of all site personnel to site-level QMS and functional training requirements.
• Be able to read and understand blueprints.
• Other duties and responsibilities as assigned.

Qualifications:

Education

• Minimum 4-Year degree or equivalent of directly-transferrable industry work experience (Engineering or Quality discipline preferred).

Experience

• Minimum of 7+ years’ experience in a regulated manufacturing environment.
• Able to independently drive all items outlined in Essential Functions.

Qualifications

• Class I, II and/or III Medical Device manufacturing experience.
• Regulated manufacturing industry experience (e.g. Aerospace, Defense, Pharmaceutical, etc.)
• Knowledge and experience with external standards:  ISO 900/9001, ISO 13485, and 21CFR 820, EU MDR, especially pertaining to product development, design controls, good manufacturing practices, supplier qualification, auditing, quality control (GD&T, Nonconforming Materials, MRB), Corrective and Preventive Actions, and customer complaints).
• Experience in effectively supporting audits by customers and external regulatory agencies.
• Strong verbal and written English language communication skills.
• Competency with Microsoft Office (i.e. Outlook, Word, Excel, and PowerPoint).
• “Hands-on” self-starter with ability to work both independently and as part of a team.
• Ability to work with a variety of functional areas, including R&D, Manufacturing, and QA.
• Ability to independently drive all items in Essential Functions.
• Lead and mentor new employees.

Preferred Skills

• Advanced Post-Secondary Education/Training/Certification coursework
• Quality certification(s) (e.g. ASQ CQE, QCI, etc.).

Physical Demands

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for an Operator I to join our organization. TOMZ offers competitive compensation and excellent benefits, including 401k, health/dental, vision and paid time off. TOMZ maintains a modern, clean, and safe facility with state-of-the-art equipment and dedication to continuous process improvement. TOMZ is registered with the FDA as a Class 2 and Class 3 Medical Device Manufacturer and is certified to ISO 13485.

Summary of Position

Reporting to Department Manager, this position will have direct responsibility for the processing of parts through various automated functions within the Department. TOMZ manufactures parts via high precision metal machining, finishing, assembly, and anodize processes for Medical Devices. The successful candidate will be expected to maintain the ISO 13485 standards documentation, prepare materials to be processed through various operations, and perform basic visual inspections on completed components.

Essential Functions

• Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
• Prepare components to be processed through various automated metal finishing operations. Ex. include loading and un-loading of automated sand blasting or tumbling equipment, racking and un-racking components to support the anodize and passivation line.
• Perform visual inspections on completed components, as required.
• Completes and compiles necessary documentation related to Quality Inspection standards.
• Ensure proper material control, identification and traceability is maintained for conforming and nonconforming material through the manufacturing processes.
• Support Quality Best Practices and GDP/GMP continuous improvement efforts.
• Utilize and navigate ERP and QMS systems to ensure inspection and traceability activities are properly documented and controlled, as needed.
• Must follow occupational Safety and Health requirements including Personal Protective Equipment (PPE) guidance and rules.
• Other duties and responsibilities are assigned.

Qualifications:

Education

• High school diploma, GED, or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred).

Experience

• Minimum of 0-2 years’ experience in a regulated manufacturing environment.

Preferred Skills/Qualifications

• Class I, II and/or III Medical Device manufacturing experience.
• Regulated manufacturing industry experience (e.g. Aerospace, Defense, Pharmaceutical, etc.)
• Knowledge of and experience with GMP/ISO standards.
• Strong background concerning the usage and care of mechanical metal finishing equipment and processes.
• Ability to use basic hand-held tools to support preventive maintenance activities.
• Ability to effectively read and understand blueprints, specifications and procedures.
• Maintains accuracy and attention to detail at all times and completes tasks in a timely manner.
• Strong verbal and written English language communication skills.

Physical Demands

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is frequently required to stand, and/or walk. The employee must occasionally lift and/or move up to 50 pounds while moving components or fixtures/racking. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

5:30pm-4 am - 15% differential
50 hours

TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a Machinist III to join our organization. TOMZ offers competitive compensation and excellent benefits, including 401k, health/dental, vision and paid time off. TOMZ maintains a modern, clean, and safe facility with state-of-the-art equipment and dedication to continuous process improvement. TOMZ is registered with the FDA as a Class 2 and Class 3 Medical Device Manufacturer and is certified to ISO 13485.

Summary of Position

Reporting to Department Manager, this position will have direct responsibility for the setup and manufacture of components within a machining Department. TOMZ manufactures parts via high precision metal machining, finishing, assembly, and anodize processes for Medical Devices. The successful candidate will be expected to maintain the ISO 13485 standards documentation, setup and operate equipment, and perform visual and dimensional inspections on machined components.

Essential Functions

• Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
• Ability to operate and maintain production on equipment within the department. Ex. include Citizen Lathes, Tsugami Lathes, Index multi-spindle lathes, Willemin Mill turns, various 3-4-5 axis mills.
• Demonstrated ability to perform offsets and change tools to maintain efficient production with minimal support.
• Ability to efficiently setup complex legacy components and basic new production orders and ensure the machine is ready for steady production.
• Perform visual and dimensional inspections on manufactured components, as required using microscope, micrometer, caliper, pin gages, thread gages, comparator, micro-hite, CMM, Vision system, etc.
• Regularly and as prescribed, perform preventive maintenance of equipment.
• Drive problem solving activities for complex machine or process issues.
• Completes and compiles necessary documentation related to Quality Inspection standards.
• Ensure proper material control, identification and traceability is maintained for conforming and nonconforming material through the manufacturing processes.
• Support Quality Best Practices and GDP/GMP continuous improvement efforts.
• Utilize and navigate ERP and QMS systems to ensure inspection and traceability activities are properly documented and controlled, as needed.
• Must maintain safe working conditions and follow occupational Safety and Health requirements including Personal Protective Equipment (PPE) guidance and rules.
• Other duties and responsibilities are assigned

Qualifications:

Education

• High school diploma, GED, or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred).
• Certification from a technical school program strongly preferred.

Experience

• Minimum of 3-7 years’ experience in a regulated manufacturing environment.

Preferred Skills/Qualifications

• Class I, II and/or III Medical Device manufacturing experience.
• Regulated manufacturing industry experience (e.g. Aerospace, Defense, Pharmaceutical, etc.)
• Knowledge of and experience with GMP/ISO standards.
• Advanced understanding of the usage and care of mechanical equipment and inspection processes.
• Ability to use hand-held tools to perform preventive maintenance or repair activities and install or change tools.
• “Hands-on” self-starter with ability to work both independently and as part of a team.
• Ability to effectively read and understand blueprints, specifications, and procedures.
• Maintains accuracy and attention to detail at all times and completes tasks in a timely manner.
• Strong verbal and written English language communication skills.
• Ability to work with a variety of functional areas, including R&D, Manufacturing, and QA, as required, accomplishing results with minimal guidance.

Physical Demands

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is frequently required to stand, and/or walk. The employee must occasionally lift and/or move up to 30 pounds while moving tooling, tool holders, or equipment replacement parts. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

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