Job Description
Job Description
Job Summary
We are seeking a dynamic and detail-oriented Quality Engineer to join our innovative medical device manufacturing team. In this role, you will be instrumental in ensuring meet the highest standards of quality, safety, and compliance. You will lead efforts in developing, implementing, and maintaining robust quality systems that align with industry regulations and customer expectations. Your proactive approach will drive continuous improvement initiatives, foster a culture of quality excellence, and support the company’s commitment to delivering reliable, safe, and effective products to the market.
Responsibilities
- Serve as the Quality Engineering lead for new product introductions (NPI) and product transfer activities, ensuring quality readiness for manufacturing and release.
- Support technology transfers from development to manufacturing, including review and approval of quality deliverables, risk documentation, and process controls.
- Reduce and control manufacturing process defects (scrap, nonconforming material, customer complaints) by leading root cause investigations and implementing corrective and preventive actions (CAPA).
- Develop and implement product quality plans, specifications, risk analyses, and FMEAs in collaboration with cross-functional product development and transfer teams.
- Establish and maintain process monitoring systems by identifying critical process parameters and implementing controls to reduce process variation and prevent defects.
- Collect, analyze, and interpret manufacturing and quality data to support product launch, transfer, and continuous improvement initiatives.
- Develop quality tools, training materials, and documentation to support new product launches and transferred products.
- Evaluate the adequacy and compliance of systems, operations, and practices against applicable regulations and internal quality documentation; support audits as assigned.
- Support and approve final process monitoring release activities for new or transferred products prior to distribution.
Requirements
- Minimum 5+ years of experience in Quality Engineering or Process Engineering within an FDA-regulated manufacturing environment (medical devices, pharmaceuticals, biotechnology, diagnostics).
- Demonstrated experience supporting new product introductions (NPI) and/or product transfers into manufacturing.
- Strong working knowledge of FDA Quality System Regulation (21 CFR Part 820), Good Manufacturing Practices (GMP), and ISO 13485.
- Hands-on experience with risk management tools (FMEA), process monitoring, CAPA, and root cause analysis.
- Experience partnering with Manufacturing, R&D, Supply Chain, and Regulatory teams during product launches and transfers.
- Strong analytical, documentation, and communication skills
Pay: From $30.00 per hour
Experience:
- FDA regulations: 5 years (Required)
- Quality assurance: 5 years (Required)
- NPI: 5 years (Required)
- ISO 13485: 5 years (Required)
Work Location: In person