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Quality Assurance Systems Supervisor

2 months ago

Fitchburg, Massachusetts, United States MICRON PRODUCTS Full time

Company Overview: Micron Products is a dynamic contract manufacturing entity that excels in thermoplastic injection molding, precision machining, assembly, and the production of silver-plated medical sensors for disposable electrodes. We collaborate with a diverse range of clients to deliver tailored manufacturing solutions and assembly services that align with their objectives.

Position Summary: The Quality Systems Manager plays a crucial role in overseeing and sustaining the Quality Management System. This includes coordinating document modifications and ensuring adherence to ISO 13485 and cGMP 21 CFR part 820 quality assurance standards.

Key Responsibilities:

- Supervise daily document control operations.

- Actively engage in the Internal Auditing program as a primary auditor.

- Uphold all company policies and serve as a model for compliance.

- Facilitate quality system training for new hires and support other departments with training on updates.

- Ensure effective communication, distribution, and control of all document changes.

- Collaborate with relevant departments to enhance process improvement initiatives.

- Compile certification documents, conduct final packaging and labeling audits, and authorize product shipments.

- Manage document change processes, ensuring compliance with established practices and standards.

- Serve as a liaison with regulatory agencies and environmental consultants.

- Monitor quality systems through trend analysis, compile metrics, and generate regular reports on quality data.

- Conduct and document investigations into customer complaints, assisting the Quality Manager in ensuring effective corrective actions.

- Provide support for manufacturing, project, and product development initiatives.

  • Develop baseline pFMEA, validation plans/protocols, and DMRs, collaborating with engineers and obtaining customer feedback.
  • Act as a gatekeeper between engineering and operations for new product introductions, ensuring compliance with internal processes.
  • Offer training support on ISO 13485, 21 CFR part 820 standards, and Micron Quality System requirements.
  • Support the corrective and preventive action process through root cause analysis, action plan development, implementation, and effectiveness verification.
  • Conduct vendor onboarding and periodic assessments for critical materials.
  • Onboarding: Evaluate vendor QMS systems and their capability to produce required materials/components.
  • Periodic Assessment: Calculate vendor ratings and engage with suppliers not meeting performance standards, issuing SCARs as necessary.
  • Sustaining: Lead internal CAPAs and supplier corrective actions for quality issues, ensuring adequate closure of actions.
Qualifications:

- Over 10 years of relevant experience.

- Bachelor of Science degree preferred.

- Proficient in reading and interpreting engineering drawings.

- In-depth knowledge of regulatory and compliance protocols for ISO 13485 and cGMP 21 CFR part 820.

- Fluent in English, with strong written and verbal communication skills.

- Capable of developing procedures, work instructions, flow charts, and forms to support quality system requirements.

- Strong facilitation, communication, and training skills are essential.

- Proficient in Microsoft Office applications; experience with IQMS ERP is advantageous.