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# Senior Staff Design Quality Engineer

- **Company:** CooperSurgical, Inc.
- **Location:** United States
- **Experience:** Expert
- **Contract:** Permanent contract
- **Skills:** Microsoft Word, Microsoft Excel, Failure Mode Effects Analysis, Microsoft PowerPoint
- **Published:** August 18, 2026
- **Apply:** https://hcjy.fa.us2.oraclecloud.com/hcmUI/CandidateExperience/en/sites/CX_1/job/12312/?mode=location

## About the Role

* Advanced working knowledge of FDA QMSR (21 CFR Part 820), ISO 13485, EU MDR.
 * Demonstrated knowledge in the application of medical device design controls, verification/validation, risk management principles per ISO 14971, and the use of risk assessment tools such as FMEA, Hazard Analysis.
 * Intermediate skill in the use of Excel, Word and PowerPoint. Advanced preferred.
 * Ability to read and understand highly technical material.
 * Proficient in reading and writing in English
 * Self-motivated and committed to a team approach
 * Strong interpersonal, organizational and project management skills. Ability and experience interfacing with senior leadership and external stakeholders.
 * Strong oral, presentation and technical writing skills
 * Demonstrated skills in decision making, problem solving, negotiation, and influencing without direct authority preferably across a broad spectrum of Quality Engineering responsibilities
 * Proven experience leading cross-functional teams in a medical device development environment.
 * Experience with Change Control, Non-conformance, Deviation, Complaints, HHEs and/or CAPAs.
 * Strong analytical and problem-solving skills with acute attention to detail.
 * Excellent communication and interpersonal skills.
 * Knowledge in Knowledge in application of IEC 62304 preferred.
 * Knowledge in one or more ISO 10993, IEC 62366, ISO 11607, ISO 11137, or ISO 11135 preferred., * 10+ years experience in Quality Engineering in the medical device industry with a Bachelors Degree, or 8+ years with a Masters Degree, experience in related engineering areas, e.g. R&D; or Manufacturing may also be applicable if experience includes work responsibilities listed above.
 * Hands-on experience in medical device product development in concept through commercialization, and/or leading design changes, improvements or remediation initiatives in sustaining operations. Knowledge in women's health a plus.



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