Title: Sr. Quality Engineer – Sustained Manufacturing
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TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a Sr. 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.
- Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
- 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.
- May support the improvement of Quality Agreements for external customers.
- Other duties and responsibilities as assigned.
- Minimum 4-Year degree or equivalent of directly-transferrable industry work experience (Engineering or Quality discipline preferred).
- Minimum of 4-6 years’ experience in a regulated manufacturing environment.
- 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 MS 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.
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.