Supplier Quality Assurance Engineer

CooperSurgical, Inc.

Remote

Position Summary:

Under the direction of the Manager, Supplier Quality, this position is responsible to support all functions of Global Supplier Quality Program are consistently in compliance with regulatory requirements and corporate standards. Ensures that quality standards are met by all suppliers to CooperSurgical.

You Will:

• Facilitates the supplier compliance program (Site audit, drive improvement in supplier performance, supplier development, supplier selection and qualification).
• Acts as a quality assurance consultant in the development and implementation of quality systems in compliance with FDA QSR, ISO 13485, MDD and CMDCAS and other relevant requirements at partner suppliers/vendors in order to support operations and development engineering.
• Works with Value Streams once Engineering and Quality Engineering; confirm there is a Supplier related improvement opportunity or Non-Conforming Material Reports (NCMRs).
• Supports development and implementation of supplier quality program by doing the following:
• Support supplier on-going monitoring and re-evaluation process.
• Manage Supplier SCAR /CAPA/ NCR and periodically provide metrics/report to Management Review Process.
• Create/ Maintain supplier quality agreements.
• Support all Procurement supplier Projects.
• Support all new Product Development that is intended for production at suppliers.
• Support all business continuity projects at suppliers.
• Update SOPs and Forms related to supplier management process as needed
• Supports internal and external QMS audits. And works as a key player in the audit’s backup rooms or inspection rooms.
• Files and maintains Supplier related documentation as per QMS.
• Perform supplier audits, conduct supplier site visits as needed to identify systemic gaps in performance expectations at suppliers and implement mitigating processes at Cooper sites, as needed.
• Collaborates with Quality Engineers, Inspectors, Value Streams as well as Purchasing teams.
• When required, submits Supplier Corrective Action Requests (SCAR) for Supplier related NCMRs. And reviews Supplier responses for appropriate root cause analysis and Corrective Actions to prevent re-occurrence of failure modes.
• Support supplier validation activities as required from Supplier Quality prospective.
• Support transfer projects for the CR site and Supplier localization projects for the CR site.
• Support and lead IQ, OQ, PQ and PPAP processes
• Performs additional assignments as required by management.

You Have:

• Knowledge of FDA QSR, ISO 13485
• Previous experience in supply chain, auditing, verification, and validation.
• Previous experience with Change Control Systems, FDA QSRs and ISO 13485.
• Excellent verbal and written communication skills and strong organizational skills
• University bachelor’s degree as a minimum, in Chemical, Electro-Mechanical, Industrial, Bioprocess Engineering or related to Life Science field. CQE, APICS, Green Belt or Black Belt certifications are a plus.
• 3 to 5 years of related experience in a regulated quality environment.
• Advance level of English speaking and writing. Traveling experience is a plus.
• With previous experience negotiating with Suppliers.
• Computer skills, MS Office, Minitab, and previous experience with ERP and QMS systems.
• Passing of background check, which may include verification of prior employment, criminal conviction history, education and driving records.

About CooperSurgical:

CooperSurgical is a leader in manufacturing and marketing multiple trusted and innovative brands that assist clinicians in improving the health of women, babies and families worldwide. Through an aggressive growth and diversification strategy, CooperSurgical has evolved its portfolio of over 600 products to include products and services used primarily by obstetricians and gynecologists in surgical and medical procedures wherever they occur: in hospitals, surgical centers, medical offices and fertility clinics.

For U.S. locations that require disclosure of compensation, the starting base pay for this role is between $65.000 and $110.000. The actual base pay includes many factors, and is subject to change and modification in the future. This position may also be eligible for other types of compensation and benefits .

Our Benefits:

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/dental/vision insurance coverage, 401(k), paid time off for vacation, personal, sick and holidays, paid family leave and many 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.

CooperSurgical is a leader in manufacturing and marketing multiple trusted and innovative brands that assist clinicians in improving the health of women, babies and families worldwide. Through an aggressive growth and diversification strategy, CooperSurgical has evolved its portfolio of over 600 products to include products and services used primarily by obstetricians and gynecologists in surgical and medical procedures wherever they occur: in hospitals, surgical centers, medical offices and fertility clinics.

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.