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Senior Quality Engineer
7 days ago
Job Description
About CooperSurgical
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. CooperSurgical is at the forefront of delivering innovative assisted reproductive technology and genomic solutions that enhance the work of ART professionals to the benefit of families. We currently offer over 600 clinically relevant medical devices to women's healthcare providers, including testing and treatment options.
CooperSurgical is a wholly-owned subsidiary of CooperCompanies (Nasdaq: COO). CooperSurgical, headquartered in Trumbull, CT, produces and markets a wide array of products and services for use by women's health care clinicians. More information can be found at www.coopersurgical.com.
Responsibilities
Perform quality assurance audits to ensure compliance and optimal manufacturing practices.
Develop plans, strategies, and implementation systems to improve manufacturing processes for products.
Resolve quality issues with suppliers, provide support for manufacturing transfers to other plants/facilities, and identify, resolve, and escalate quality issues within the plant.
Develop Process Failure Mode and Effect Analysis (pFMEA) to manage process risks.
Perform various root cause analysis investigations for Complaints, CAPA, Audit Findings, and Non-Conformance Reports.
Qualifications
Bachelor's degree in biomedical engineering, or related field, plus 10 years of progressively responsible experience in the medical device industry.
Experience must include electronic medical devices (such as defibrillators, patient monitors, sensors, x-ray equipment).
As an employee of CooperSurgical, you'll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits. Please visit us at www.coopersurgical.com to learn more about CooperSurgical and the benefits of becoming a member of our team.
To all agencies: Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.
We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.
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