Position Summary
TransducerWorks, a premier medical device contract manufacturer based in Centre Hall, PA, is seeking an experienced and collaborative Senior Quality Specialist. In this role, you will work closely with the local Quality Manager to maintain our ISO 13485 certified Quality Management System (QMS) and ensure strict compliance with FDA regulations. You will serve as a key technical expert for process validations, oversee supplier quality, and act as a pivotal bridge between our local manufacturing site and our corporate Quality leadership based in France.
Key Responsibilities
- QMS Support: Assist the local Quality Manager in maintaining, auditing, and improving the site's ISO 13485 compliant QMS.
- Documentation & SOPs: Draft, review, and update Standard Operating Procedures (SOPs), work instructions, and quality system documentation to ensure regulatory compliance and operational clarity.
- Process Validation: Lead, review, and execute Installation, Operational, and Performance Qualifications (IQ/OQ/PQ) for manufacturing processes and equipment.
- Supplier Quality: Manage supplier performance, handle supplier corrective action requests (SCAR), and conduct external supplier quality audits as needed.
- Regulatory Compliance: Ensure all operations align with FDA 21 CFR Part 820, ISO 13485, and ISO 14971 risk management standards.
- Cross-Functional Collaboration: Collaboration with global quality team.
- CAPA & NCR Management: Drive Non-Conformance Reports (NCR) and Corrective and Preventive Actions (CAPA) investigations to root cause resolution.
Qualifications & Requirements
- Education: Bachelor’s degree in Engineering, Manufacturing Engineering, Quality Engineering, or a related technical discipline.
- Experience: 7 to 12 years of proven experience as a Quality Specialist within the medical device industry.
- Statistical Methods: Strong expertise in statistical techniques, including Statistical Process Control (SPC), sampling plans (AQL), and data analysis tools.
- International Context: Experience working within an international or global corporate environment, with a proven ability to collaborate effectively across different cultures and time zones.
- Technical Writing: Exceptional technical writing skills with a track record of authoring clear, concise, and compliant procedural documentation (SOPs).
- Technical Knowledge & Regulations: Deep expertise in IQ/OQ/PQ validation principles, ISO 14971 risk management, FDA regulations (21 CFR Part 820), and ISO 13485 standards.
- Travel: Ability to travel domestically for supplier audits.
- Work Authorization: Must be legally authorized to work in the United States. Sponsorship (H-1B visa, etc.) is not available for this position.
Preferred Qualification
- Experience working within or monitoring controlled environments / cleanrooms.
- ASQ Certified Quality Engineer (CQE) designation.
Physical Demands & Work Environment (ADA Compliance)
- Must be able to regularly access and move about the manufacturing floor and enter controlled environments.
- Must be capable of complying with cleanroom gowning requirements, including wearing personal protective equipment (PPE) such as hairnets, gowns, gloves, and face mask.
Equal Employment Opportunity (EEO) Statement
TransducerWorks is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Benefits:
- 401(k)
- Dental insurance
- Flexible spending account
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Work Location: In person
