Design Quality Engineer Senior

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 business unit of CooperCompanies (Nasdaq: COO), we're driven by a unified purpose of helping people 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.

Knowledge, Skills and Abilities:

- Knowledge of applicable laws and regulations.
- Intermediate skills in Excel, Word and PowerPoint. Advanced skills preferred.
- Ability to read and understand highly technical material.
- Proficient in reading and writing in English.
- Self-motivated and committed to a team approach.
- Knowledge of ISO 13485 and ISO 14971
- Strong interpersonal, organizational and project management skills.
- Strong oral, presentation and technical writing skills.
- Strong decision-making skills, preferably across a broad spectrum of Quality Engineering responsibilities.
- Experience leading cross-functional teams in a medical device development environment.
- Strong analytical and problem-solving skills with attention to detail. Knowledge of statistics and how to apply, evaluate, and provide recommendations from data.

Work Environment:

- Production/Clean Room/Warehouse/Office Environment which may require long periods of sitting, standing, or getting up and down throughout the day.
- Occasionally lift to 35 pounds.

Experience:

- 5+ years experience in Quality Engineering in the medical device industry. Experience in related engineering areas, e.g. R&D; or Manufacturing may also be applicable if experience includes work responsibilities listed above.
- Experience in medical devices, with knowledge in women’s health is preferred.

Education:

- Bachelor’s Degree or higher in Science or Engineering (or related field).
- Certification in Quality Engineering (ASQ Certified Quality Engineer).