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Quality Assurance Manager

3 months ago

Cambridge, United States Aequor Full time

Quality Assurance Manager (Hybrid Job in Cambridge, MA)

Location: Cambridge, MA

Terms: Contract W2

Duration : 12 Months Contract (Can Be Extended For Long)


Description:


Flexible Schedule - Onsite AMA at least 2 days per week

M-F (8am - 5:00 pm, flexible)

Ideal Candidate: 4+ years of working experience. Looking for validation, method, quality, and experience in medical device. Project management experience. Nice to have: previous biomedical, electrical, or mechanical engineering background.

Skills Nice To Have:

BS or BE in Engineering and previous experience in the medical device and/or pharmaceutical industries

- 5 years current experience with engineering processes/procedures and quality tools. - Major contributions to or the leadership of projects from development through the 510k and PMA approval process.

- Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification/validation, DOE/SPC process optimization & validation (IQ, OQ, PQ), P/DFMEA.

- Product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions.

- Experience in test or inspection method design and development - Small scale device assembly and/or benchtop testing experience.

- Experience with Automated Test Equipment (ATE). – Experience with regard to Measurement Systems Analysis/GRR principles, including study design/execution/troubleshooting

- Experience with Deviations, CAPAs, Change controls and document review/approval

- Strong critical thinking, problem solving, risk assessment, and risk management skills.

- Must be capable of working on multiple projects in a deadline driven environment.