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.
- 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.
- Solid analytical and problem-solving skill

📌 Senior Staff Design Quality Engineer (Gurugram)
🏢 CooperCompanies
📍 Gurugram