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TOMZ Corporation is looking for a Quality Systems Specialist to join our organization. A leader in manufacturing of devices and components for major medical device companies, TOMZ offers competitive compensation and excellent benefits. Those include 401k, health/dental, vision and paid time off. TOMZ maintains modern, clean, and safe facilities 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

The position will be responsible for ensuring global operational adherence and compliance to TOMZ’s Quality Management System (QMS) requirements. This role will be expected to provide input on, and contribute to, development and implementation of Quality System improvement strategies and approaches.

Essential Functions

• Lead Quality Management System initiatives and continuous improvement activities.
• Generate project Quality Plans for the QMS and Organizational Objectives.
• Facilitate organizational compliance training and continual audit/assessment preparedness.
• Actively support site customer-requested auditing activities (Customer and Regulatory Agencies).
• Coordinate tracking/trending & reporting of quality system metrics and inputs to Management Review(s).
• Internal Auditing:
  • Lead efforts to ensure all internal audits are performed as scheduled.
  • Assess compliance to FDA and ISO 13485 requirements, as well as the internal Quality Management System, including investigation observations/findings and reporting.
• Corrective/Preventive Actions (CAPA):
  • Responsible for CAPA system administration, CAPA tracking and trending, and, as necessary, lead CAPA implementation efforts.
• Supplier Quality Management:
  • Lead Qualification activities and maintenance of the Approved Supplier List (ASL).
  • Monitor and facilitate timely execution of Supplier/vendor Corrective Actions (SCAR).
• Documentation Control:
  • Support local Document Control (PLM) and Enterprise Resource Planning (ERP) systems.
• Complaints Investigation/Returned Materials Analysis:
  • Knowledge of process(es) for investigation/analysis of returned/complaint materials.
• Nonconforming Material (NCM) Control:
  • Knowledge of ID, traceability, containment requirements, Material Review Board (MRB) responsibilities and handling of NCM.
• Ensure compliance of all personnel to QMS requirements.
• Ensure adherence to training requirements regarding Quality Management System elements, controls, processes and procedures.
• 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 4-6 years’ experience in a regulated manufacturing environment.

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.

Preferred Skills

• 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.

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.

This position will minimally require intermittent travel between TOMZ Corporation sites and/or supplier facilities within the United States. 

TOMZ Corporation is looking for a Project Manager to join our organization. A leader in manufacturing of devices and components for major medical device companies, TOMZ 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

Reporting to the Chief Commercial Officer, this position is primarily responsible for coordinating with cross-functional teams to successfully managing the development of new and existing Projects. Utilizing project management and system tools to track projects deliverables.

Essential Functions

• Manage and coordinate activities related to the development, documentation, and validation of medical devices.
• Generate and maintain project plans, schedules, task lists and project risk registers that enable the team to execute project activities.
• Coordinate activities across different functional groups within the company, customers, and suppliers to ensure successful completion of project goals and milestones.
• Track project health in terms of schedule, budget, and technical risks utilizing project tracker.
• Prepares and presents project status reports to internal and external stakeholders.
• Proactively anticipate project risks and issues, and carefully formulates and implements risk mitigations and corrective/preventive actions.
• Create and maintain documentation per company procedures and 13485 requirements.
• Coordinates and directs customer meetings and visits, and day-to-day customer communication.
• Interfaces with suppliers to manage schedules and priorities.
• Manage financial aspects of internal and customer programs.
• Perform post-project reviews to analyze reasons for project issues that can be addressed and prevented in future projects. 
• Support team members to strengthen and achieve company-wide initiatives.
• Other duties as assigned.

Qualifications:

• 4-Year degree or 5+ years manufacturing/equivalent of directly transferrable industry work experience
• Experience in manufacturing in a regulated engineering/manufacturing environment.
• Must be able to fully interpret technical drawings, specifications, process capability, and CNC manufacturing knowledge.

Preferred Skills:

• Ability to communicate complex ideas, Project status and risks to internal and external stake holders.
• Willingness to travel, if required.
• Must maintain high ethical standards.
• Must demonstrate good organizational skills.
• Strong computer skills, including Excel, MS Office suite and MS Project.
• Strong analytical skills, must be able to obtain, evaluate, and apply secondary research information.
• Technical report preparation and formal presentation skills.
• Excellent verbal and written communication skills
• Demonstrated ability to work in a fast-paced environment.
• Self-motivated with a can-do attitude.
• Customer-centric mindset.

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 is looking for a Project Manager to join our organization. A leader in manufacturing of devices and components for major medical device companies, TOMZ 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

Reporting to the Chief Commercial Officer, this position is primarily responsible for coordinating with cross-functional teams to successfully managing the development of new and existing Projects. Utilizing project management and system tools to track projects deliverables.

Essential Functions

• Manage and coordinate activities related to the development, documentation, and validation of medical devices.
• Generate and maintain project plans, schedules, task lists and project risk registers that enable the team to execute project activities.
• Coordinate activities across different functional groups within the company, customers, and suppliers to ensure successful completion of project goals and milestones.
• Track project health in terms of schedule, budget, and technical risks utilizing project tracker.
• Prepares and presents project status reports to internal and external stakeholders.
• Proactively anticipate project risks and issues, and carefully formulates and implements risk mitigations and corrective/preventive actions.
• Create and maintain documentation per company procedures and 13485 requirements.
• Coordinates and directs customer meetings and visits, and day-to-day customer communication.
• Interfaces with suppliers to manage schedules and priorities.
• Manage financial aspects of internal and customer programs.
• Perform post-project reviews to analyze reasons for project issues that can be addressed and prevented in future projects. 
• Support team members to strengthen and achieve company-wide initiatives.
• Other duties as assigned.

Qualifications:

• 4-Year degree or 5+ years manufacturing/equivalent of directly transferrable industry work experience
• Experience in manufacturing in a regulated engineering/manufacturing environment.
• Must be able to fully interpret technical drawings, specifications, process capability, and CNC manufacturing knowledge.

Preferred Skills:

• Ability to communicate complex ideas, Project status and risks to internal and external stake holders.
• Willingness to travel, if required.
• Must maintain high ethical standards.
• Must demonstrate good organizational skills.
• Strong computer skills, including Excel, MS Office suite and MS Project.
• Strong analytical skills, must be able to obtain, evaluate, and apply secondary research information.
• Technical report preparation and formal presentation skills.
• Excellent verbal and written communication skills
• Demonstrated ability to work in a fast-paced environment.
• Self-motivated with a can-do attitude.
• Customer-centric mindset.

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 is looking for a motivated Associate Project Manager to join our organization. A leader in manufacturing of devices and components for major medical device companies, 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 the Chief Commercial Officer, this position is responsible for assisting the planning, execution, monitoring, and completion of projects with cross-functional teams to successfully managing the development of new and existing Projects. With assistance utilizing project management and system tools to track projects deliverables.

Essential Functions

• Assist all functional stakeholders to manage and coordinate activities related to the development, documentation and validation of medical devices utilizing TOMZ project tracker.
• With Guidance from Team Leader, support members of the organization understand their roles and responsibilities. Motivate and inspire each other to achieve project goals and objectives.
• Support the implementation of Change Management process to effectively manage changes to project scope, schedule, and objectives defined by the customer while minimizing disruptions. This requires assessing impacts, obtaining approvals, and communicating changes to relevant stakeholders.
• With guidance, generate and maintain project plans, schedules, task lists and project risk registers that enable the team to execute project activities.
• Coordinate activities across different functional groups within the company, customers, and suppliers to ensure successful completion of project goals and milestones.
• Track project health in terms of schedule, budget, and technical risks.
• Prepare and present project status reports to internal and external stakeholders as needed.
• Proactively anticipate project risks and issues, and carefully formulates and implements risk mitigations and corrective/preventive actions.
• Create and maintain documentation per company procedures and 13485 requirements.
• With support lead internal and customer meetings and visits, and day-to-day customer communication and documenting with weekly meeting minutes. Providing  
• Support interface with suppliers to drive schedules and manage priorities.
• Support financial aspects of internal and customer programs.
• Travel is required 5-10 % of the time to visit customers and other sites.
• Other duties as assigned.

Qualifications:

Education/Experience

• 4-Year degree or 2+ years manufacturing/equivalent of directly transferrable industry work experience and prior experience with project management
• Experience in a regulated engineering/manufacturing environment with mechanical, tool design, and manufacturing processes preferred (preferably in a Medical Device)

Qualifications

• Must be able to support technical drawings, specifications, process manufacturing knowledge.
• Ability to communicate complex ideas, Project status and risks to internal and external stake holders.
• Willingness to travel
• Must maintain high ethical standards.

Preferred Skills

• Must demonstrate good organizational skills.
• Strong computer skills, including the MS Office suite and MS Project.
• Strong analytical skills, must be able to obtain, evaluate, and apply secondary research information.
• Technical report preparation and formal presentation skills.
• Excellent verbal and written 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 30 pounds while moving components, fixtures, equipment and/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 is looking for a Quality Engineering Manager to join our organization. A leader in manufacturing of devices and components for major medical device companies, 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 Leadership and management of site-level Quality Engineering personnel and resources to ensure adherence and compliance to TOMZ's Quality Management System.

Essential Functions

• This position may have direct-reporting responsibilities for daily activities of Quality personnel.
• Designated Site-level Management Representative for assurance of compliance to the TOMZ Quality Management System.
• Drive and support QMS initiatives and continuous improvement activities.
• Support establishment and maintenance of site regulatory registrations (ISO 13485, FDA, etc.).
• Provide organizational Quality Leadership, coaching, mentoring and guidance to all Quality Engineering, as well as cross-functional teams.
• Work closely with Engineering and Operations teams to identify and drive actions that reduce the Cost of Poor Quality.
• Drive integration of new manufacturing capabilities, new test methods and innovation in technology, cost/labor reduction opportunities, product transfers, design transfers and sustained manufacturing customers.
• Provide Leadership and Guidance for Quality functions including, Product and Process Risk Management, Test Method Selection and Development, Control Point establishment, Risk and Severity-based Sampling Plan, Process Validation Strategy, Complaint Handling/Returns, Corrective/Preventive Actions, and Nonconforming Material Handling.
• Provide oversight and ensure compliance of Quality System support elements for the site QMS: Complaint Handling, Corrective and Preventive Actions, Nonconforming Materials Controls; trending of associated metrics to drive continuous improvement initiatives.
• Provide Leadership and Guidance for Development Engineering, Sustained Manufacturing and Continuous Improvement/Continuation Engineering activities and initiatives.
• Provide Leadership and Guidance for Risk Management (Process FMEAs), Limit Characterization, Inspection Controls, Technical Root Cause Investigation, and resulting Corrective Actions.
• Administration of employment practices, including, but is not limited to, monitoring time & attendance, hiring, terminating, counseling and disciplinary actions for all employees, and performed in compliance with Federal and local laws, as well as TOMZ policies.
• 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 1-3 years Leadership/Supervisory-level experience, with budget and decision-making authority/responsibilities.
• Minimum of 5 years of experience in a regulated manufacturing environment.

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.

Preferred Skills

• Experience in coaching and developing subordinates, utilizing performance management tools and disciplines while increasing employee engagement and retention.
• 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.

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.