Quality Inspector I

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

• Perform inspection and testing activities on incoming materials, in-process components, and finished goods in accordance with approved procedures, specifications, and sampling plans.

• Conduct visual, dimensional, and functional inspections using calibrated measuring instruments (e.g., calipers, micrometers, gauges) and test equipment.

• Review and verify Device History Records (DHRs), batch records, and other quality documentation for completeness, accuracy, and compliance.

• Identify, document, and escalate nonconforming materials or products in accordance with established procedures; support material segregation and containment activities.

• Initiate and/or support nonconformance reports (NCMRs) and assist in investigations as required.

• Perform in-process and final audits to ensure adherence to manufacturing procedures and quality standards.

• Accurately record inspection and test results in electronic and/or paper-based systems in compliance with Good Documentation Practices (GDP).

• Support line clearance activities and verify readiness for production runs.

• Collaborate cross-functionally with Manufacturing, Engineering, and Quality Engineering to address quality issues and support continuous improvement initiatives.

• Ensure compliance with applicable regulatory requirements including FDA 21 CFR Part 820, ISO 13485, GMP, and internal procedures.

• Maintain inspection equipment and ensure calibration status is current prior to use.

• Follow all safety, cleanliness, and contamination control practices, including cleanroom procedures where applicable.

• Support internal audits, external regulatory inspections, and customer audits as needed.

• Support new projects and improvement actions within assigned area.

• Perform other duties as assigned.

 

Travel: 

• Not required or minimal (<5%), as needed for training or support activities.

• Working knowledge of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and basic quality system requirements.

• Familiarity with FDA 21 CFR Part 820 and/or ISO 13485 standards preferred.

• Ability to read and interpret engineering drawings, specifications, procedures, and inspection criteria.

• Proficiency in the use of basic inspection tools and measurement equipment.

• Strong attention to detail and ability to detect defects and deviations.

• Basic understanding of sampling plans and inspection methods.

• Effective written and verbal communication skills.

• Basic computer skills (e.g., Microsoft Office, electronic quality systems).

• Ability to work independently and as part of a team in a fast-paced, regulated environment.

• Strong organizational and multitasking abilities.

• Experience in documenting deviations and/or variances preferred.

• Production/Clean Room/Warehouse/Office environment which may require long periods of sitting, standing, or getting up and down throughout the day. 
• Occasional lifting up to 35 pounds.
• Adherence to gowning and cleanroom requirements may be required. 

 

Work Environment:

 

Experience:

• 0+ years of experience in a quality, manufacturing, or regulated environment.

 

Education:

• Secondary Education degree preferable or 9th Secondary grade.

• Quality-related certifications (e.g., ASQ Certified Quality Inspector) are a plus.

• Basic proficiency in English (reading, writing, and comprehension) preferred.

 

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.  If you are interested in applying and require special assistance or accommodations due to a disability, please contact us at talent.acquisition@coopersurgical.com