About CooperSurgicalCooperSurgical 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 .Must have strong working knowledge in: 21CFR820, ISO13485:2016, ISO14971 Process validation (IQ/OQ/PQ/TMV/MSA) Ideally both in transferring/scaling up existing processes as well as developing new processes NCMR, CAPA, Change control and GDP experience At least 15 years' experience in Quality Management/Quality Systems/Audit Program Management Experience in integrations/acquisitions with respect to ensuring quality requirements are preserved pre-post integration. Presentation of results in a logical and clear manner Ability to analyze information and come to conclusions based on presented data Ability to communicate effectively both orally and in writing Strong organizational and interpersonal skills Ability to learn and utilize computer in standard business applications including electronic document control, word processing, spreadsheets and databases.
Background in statistics with respect to process control (reliability, capability, SPC, etc.) BS Degree in Life Science, Engineering or equivalent program is preferred Certified Lead Auditor 2016 (ISO 13485) is preferred ASQ or equivalent certification and/or relevant work experience is highly preferred. Other Professional certification is an advantage (ie, CQA, CQE, SQE, CQM, Etc) Travel up to 25% (To our Manufacturing Plants, Globally Based) 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 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.Ensure that Quality Systems are designed and operating in a way to provide appropriate support in all GxP areas of the company and are in compliance with current ISO and GMP standards (cGMP) both US FDA and EU. Develop/Lead Quality Engineers as they continuously improve the manufacturing plant processes and procedures to meet Quality, Compliance and Business objectives.
Trend Monthly Quality data (NCMR, CAPA, etc.) to ensure quality resources are being properly deployed to address the needs of the business. Drive continuous improvement and operational excellence culture through self-detecting and self-correcting processes and systems and instilling strong ownership and accountability Coordinate and support Manufacturing Process Validation (VMP, IQ, OQ, PQ) to make sure that all validation activities are in accordance with ISO 13485:2016, FDA 21 CFR Part 820, MDSAP and other applicable regulations.
Coordinate the execution of Measurement System Analysis Validations (MSA), as per business needs.Support Validation activities during acquisition and transfer projects, as per site business needs.timePosting Date: 2024-04-01.
