CooperSurgical
Overview
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.
Work location:
Trumbull, CT (on-site)
We’re hiring
– If you’re interested in learning more, please visit coopercos.com/careers
About CooperSurgical
JOB DESCRIPTION: 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.
Responsibilities
Lead SCAR, SCN and Supplier Nonconformance processes
Supplier Development activities
Risk Assessments
Manage Supplier Quality sustaining activities
Facilitate the supplier compliance program (site audit, drive improvement in supplier performance, supplier development, supplier selection and qualification)
Act 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 to support operations and development engineering
Work with Value Streams to confirm supplier-related improvement opportunities or Non-Conforming Material Reports (NCMRs)
Support development and implementation of the supplier quality program, including on-going monitoring and re-evaluation
Manage Supplier SCAR / CAPA / NCR and periodically provide metrics/reports to Management Review Process
Create/Maintain supplier quality agreements
Support all Procurement supplier projects and all new product development intended for production at suppliers
Support business continuity projects at suppliers
Update SOPs and forms related to supplier management process as needed
Support internal and external QMS audits and participate in audit backup/inspection rooms
File and maintain supplier-related documentation per QMS
Perform supplier audits and site visits as needed to identify gaps and implement mitigating processes
Collaborate with Quality Engineers, Inspectors, Value Streams and Purchasing teams
Submit SCARs for NCMRs when required and review supplier responses for root cause analysis and corrective actions
Support supplier validation activities from a Supplier Quality perspective
Support transfer projects and supplier localization projects
Support IQ, OQ, PQ and PPAP processes
Performs additional assignments as required by management
Travel:
10% to 25%
Qualifications
Knowledge of FDA QSR, ISO 13485, EUMDR, ISO 14971
Knowledge and experience with a regulated Supplier Management process
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
Bachelor’s Degree in Chemical, Electro-Mechanical, Industrial, Bioprocess Engineering or related Life Science field or equivalent experience; CQE, APICS, Green Belt or Black Belt certifications are a plus
5+ years of related experience in a regulated quality environment
Advanced English speaking and writing; traveling experience is a plus
Experience negotiating with suppliers
Computer skills (MS Office, Minitab) and experience with ERP and QMS systems
Passing of background check (may include verification of prior employment, criminal history, education, driving records)
Understanding of cost drivers per market, commodity or segment
GD&T knowledge; experience in supply chain, auditing, verification and validation
Change Control Systems and Design Control experience
Experience: 3–5 years in regulated quality environment
3–5 years in working with Supplier Management processes
Education
Bachelor’s Degree in Chemical, Electro-Mechanical, Industrial, Bioprocess Engineering or related Life Science field or equivalent experience; CQE, APICS, Green Belt or Black Belt certifications are a plus
Our Benefits As an employee of CooperSurgical, you’ll receive an outstanding total compensation plan including medical coverage, 401(k), parental leave, fertility benefits, paid time off, holidays, and more. For details, visit www.coopersurgical.com.
To all agencies: Please do not contact CooperSurgical employees directly about this opening. All resumes submitted by search firms/employment agencies will be the property of CooperSurgical unless engaged by CooperSurgical for this position. We are an equal opportunity employer.
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.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance Industries: Medical Equipment Manufacturing
Referrals increase your chances of interviewing at CooperSurgical. Get notified about new Supplier Quality Engineer jobs in
Trumbull, CT .
#J-18808-Ljbffr
Work location:
Trumbull, CT (on-site)
We’re hiring
– If you’re interested in learning more, please visit coopercos.com/careers
About CooperSurgical
JOB DESCRIPTION: 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.
Responsibilities
Lead SCAR, SCN and Supplier Nonconformance processes
Supplier Development activities
Risk Assessments
Manage Supplier Quality sustaining activities
Facilitate the supplier compliance program (site audit, drive improvement in supplier performance, supplier development, supplier selection and qualification)
Act 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 to support operations and development engineering
Work with Value Streams to confirm supplier-related improvement opportunities or Non-Conforming Material Reports (NCMRs)
Support development and implementation of the supplier quality program, including on-going monitoring and re-evaluation
Manage Supplier SCAR / CAPA / NCR and periodically provide metrics/reports to Management Review Process
Create/Maintain supplier quality agreements
Support all Procurement supplier projects and all new product development intended for production at suppliers
Support business continuity projects at suppliers
Update SOPs and forms related to supplier management process as needed
Support internal and external QMS audits and participate in audit backup/inspection rooms
File and maintain supplier-related documentation per QMS
Perform supplier audits and site visits as needed to identify gaps and implement mitigating processes
Collaborate with Quality Engineers, Inspectors, Value Streams and Purchasing teams
Submit SCARs for NCMRs when required and review supplier responses for root cause analysis and corrective actions
Support supplier validation activities from a Supplier Quality perspective
Support transfer projects and supplier localization projects
Support IQ, OQ, PQ and PPAP processes
Performs additional assignments as required by management
Travel:
10% to 25%
Qualifications
Knowledge of FDA QSR, ISO 13485, EUMDR, ISO 14971
Knowledge and experience with a regulated Supplier Management process
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
Bachelor’s Degree in Chemical, Electro-Mechanical, Industrial, Bioprocess Engineering or related Life Science field or equivalent experience; CQE, APICS, Green Belt or Black Belt certifications are a plus
5+ years of related experience in a regulated quality environment
Advanced English speaking and writing; traveling experience is a plus
Experience negotiating with suppliers
Computer skills (MS Office, Minitab) and experience with ERP and QMS systems
Passing of background check (may include verification of prior employment, criminal history, education, driving records)
Understanding of cost drivers per market, commodity or segment
GD&T knowledge; experience in supply chain, auditing, verification and validation
Change Control Systems and Design Control experience
Experience: 3–5 years in regulated quality environment
3–5 years in working with Supplier Management processes
Education
Bachelor’s Degree in Chemical, Electro-Mechanical, Industrial, Bioprocess Engineering or related Life Science field or equivalent experience; CQE, APICS, Green Belt or Black Belt certifications are a plus
Our Benefits As an employee of CooperSurgical, you’ll receive an outstanding total compensation plan including medical coverage, 401(k), parental leave, fertility benefits, paid time off, holidays, and more. For details, visit www.coopersurgical.com.
To all agencies: Please do not contact CooperSurgical employees directly about this opening. All resumes submitted by search firms/employment agencies will be the property of CooperSurgical unless engaged by CooperSurgical for this position. We are an equal opportunity employer.
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.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance Industries: Medical Equipment Manufacturing
Referrals increase your chances of interviewing at CooperSurgical. Get notified about new Supplier Quality Engineer jobs in
Trumbull, CT .
#J-18808-Ljbffr