Design Quality
Job in
Boston, Suffolk County, Massachusetts, 02114, USA
Listed on 2026-06-03
Listing for:
Apolis
Full Time
position Listed on 2026-06-03
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist -
Engineering
Quality Engineering, Regulatory Compliance Specialist
Job Description & How to Apply Below
- Job Title: Design Quality
- Location: Bothell, WA | Cambridge, MA | Plymouth, MN
- Tax Term (W2, C2C):
Any - Job Type (Permanent/Contract) :
Contract - Duration: 6+ months
- Pay Range: $50 - $55/hr on W2
Key Responsibilities
- Design Controls: Represent Quality Assurance on product development teams, ensuring compliance with FDA 21 CFR 820.30 and ISO 13485.
- Risk Management: Lead risk management activities, including Hazard Analysis, Use FMEA (Failure Mode and Effects Analysis), and Design FMEA.
- Verification & Validation (V&V): Develop, review, and approve plans, protocols, and reports for design verification and validation tests.
- Documentation: Maintain the Design History File (DHF) and ensure all documentation is compliant.
- Test Method Validation (TMV): Validate testing methods to ensure measurement accuracy.
- Change Control: Evaluate the impact of design changes on product quality and safety.
- Supplier Quality: Collaborate on component selection and supplier quality requirements.
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