Sr. Quality Engineer
SkyWater is partnering with a growing medical device contract manufacturer who’s looking for a Sr. Quality Engineer to join their team! The Sr. QE will be responsible for overseeing non-conformance events, handling customer complaints, leading CAPA projects, internal auditing & supporting external audits and validating manufacturing processes. This position offers the opportunity to make a direct impact on product quality, manufacturing process efficiency, and organizational growth within a collaborative & fast-paced environment. Our client is offering a competitive base salary, bonus potential, excellent benefits and opportunities to advance your career within their organization!
Responsibilities
- Lead customer quality complaint investigations.
- Oversee corrective and preventative action (CAPA) projects.
- Support manufacturing process validations and transfers.
- Partner with cross-functional engineering teams on non-conformance events.
- Lead internal quality audits and support external/supplier audits as needed.
- Other duties or responsibilities as assigned.
Desired Skills and Experience
- Bachelor’s Degree in Mechanical Engineering or related field.
- 5+ years of quality engineering experience (or combination of relevant experience).
- Experience working in medical device manufacturing, ISO 13485, or similar regulated setting.
- Strong experience in root-cause analysis, process qualification, and quality auditing preferred.
- Excellent communication skills (both written & verbal).
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