Senior Staff Design Quality Engineer

• 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.

CooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we’re driven by a unified purpose to enable patients to experience life’s beautiful moments. Guided by our shared values - dedicated, innovative, friendly, partners, and do the right thing - our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women’s and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at www.coopersurgical.com.