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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 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 cater to a diverse clientele, providing tailored manufacturing solutions and assembly services to achieve 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.

- Serve as a primary internal auditor, actively engaging in the Internal Auditing program.

- Uphold all company policies and exemplify adherence to these standards.

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

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

- Collaborate with relevant departments to support 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.

- Act 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 evaluating the effectiveness of corrective actions.

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

  • Develop baseline pFMEA, validation plans/protocols, and DMRs, reviewing them with engineers and seeking customer feedback.
  • Act as a gatekeeper between engineering and operations for new product introductions, ensuring compliance with Micron's processes.
  • Offer 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 QMS system and capability to produce the required materials/components in collaboration with engineers.
  • Periodic Assessment: Calculate vendor ratings and communicate with suppliers who do not meet performance standards, issuing SCARs as necessary and following up on required actions.
  • Sustaining: Lead internal CAPAs and supplier corrective actions (SCARs) for quality issues related to processes and products, ensuring adequate closure through evaluation of responses and objective evidence.
Qualifications:

- A minimum of 10 years of relevant experience.

- A Bachelor of Science degree is preferred.

- Proficiency in reading and interpreting engineering drawings is essential.

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

- Fluency in reading, writing, and speaking English is required.

- Ability to develop procedures, work instructions, flow charts, and forms to support quality system requirements.

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

- Proficiency in Microsoft Office applications is required.

- Experience with IQMS ERP is advantageous.