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. 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)

Scope:

The Quality Control Inspector is responsible for inspecting components, subassemblies, and assemblies within the CooperSurgical Trumbull, CT facility.The Quality Control inspector will ensure components, subassemblies, and assemblies comply with approved specifications.

The Quality Control Inspector is responsible for performing routine inspections of components, subassemblies, and finished products to ensure compliance with approved drawings, specifications, inspection plans, and regulatory requirements. This role supports product quality, safety, and effectiveness while maintaining compliance with current Good Manufacturing Practices (cGMP), FDA Quality System Regulations (21 CFR 820), and other applicable quality standards.

• Perform routine and detailed inspections of incoming materials, in-process goods, and finished products.
• Conduct visual, dimensional, mechanical, and functional inspection using approved methods, tools, and equipment.
• Ensure components, subassemblies, and finished products comply with approved company drawings and specifications.
• Document inspection results to ensure full traceability.
• Identify, document, and report defects or nonconformances (NCMRs)
• Support Site Quality Management in determining disposition of product (accept, reject, rework, return to vendor) in accordance with approved company procedures.
• Collaborate cross-functionally to assist with investigations and resolve potential quality issues.
• Support corrective and preventive action (CAPA) activities.
• Participate in internal and external audits and inspections as required.
• Participate in other projects as required by Quality Management.
• Perform other duties as assigned.

Travel: This position may require 5-10% domestic travel.

Knowledge, Skills and Abilities:

• Working knowledge of cGMP, FDA quality system regulations, and quality inspection practices in a regulated environment.
• Ability to interpret drawings, specifications, and inspection methods.
• Working knowledge of 21 CFR 820, ISO 13485, EU MDR, MDSAP, and other global standards
• Experience and ability in reading and interpreting engineering drawings.
• Proficiency using inspection tools and measuring equipment.
• Strong attention to detail and accuracy.

• Strong organizational, interpersonal, verbal, and written communication skills (clear, concise, effective with a variety of stakeholders).

• Must be proficient in the use of Microsoft Excel, Microsoft Word, Outlook, and PowerPoint.

• Strong organizational, troubleshooting, and problem-solving skills.

Work Environment:

• 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.

Experience:

• 2+ years in medical device/healthcare manufacturing or quality inspection experience in an FDA-regulated environment.
• Certifications: ASQ Certification (Certified Quality Inspector or Certified Quality Technician) preferred.

Education:

• High School Diploma or GED required.

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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 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.