Quality Assurance Systems Supervisor

2 weeks ago

Fitchburg, Massachusetts, United States MICRON PRODUCTS Full time

Company Overview: Micron Products is a versatile 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 modification activities 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 lead internal auditor.

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

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

- Ensure that all document control modifications are effectively communicated, distributed, and managed.

- Collaborate with relevant departments to support process improvement initiatives.

- Compile certification documentation, 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 applicable 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 activities.

  • Develop baseline pFMEA, validation plans/protocols, and DMRs, reviewing them with engineers and obtaining customer feedback.
  • Act as a gatekeeper between engineering and operations for new product introductions, ensuring compliance with Micron's processes.
  • Deliver training support in ISO 13485, 21 CFR part 820 standards, Micron Quality System requirements, auditing, and statistical process control.
  • Support the corrective and preventive action process by conducting root cause analyses, assisting in action plan development, and verifying the effectiveness of implemented actions.
  • Conduct vendor onboarding and periodic assessments for critical materials.
  • Onboarding: Evaluate the vendor's Quality Management System and assess their capability to produce the required materials/components in collaboration with engineers.
  • Periodic Assessment: Calculate vendor ratings and engage with suppliers who do not meet performance standards, issuing SCARs as necessary and following up on required actions.
  • Sustaining: Lead and manage internal CAPAs and supplier corrective actions for process and product-related quality issues, ensuring adequate closure through objective evidence evaluation.
Qualifications:

- Minimum of 10 years of relevant experience.

- Bachelor of Science degree preferred.

- Proficient in reading and interpreting engineering drawings.

- Comprehensive understanding of regulatory and compliance standards for ISO 13485 and cGMP 21 CFR part 820.

- Fluent in reading, writing, and speaking English.

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

- Strong facilitation, communication, and training skills are highly recommended.

- Proficient in Microsoft Office applications.

- Experience with IQMS ERP is advantageous.

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