CooperCompanies · 17 hours ago
Quality Control Inspector II
95 Corporate Drive, Trumbull, CT, 06611, US
Full-time
Onsite
Entry, Mid Level
2+ years expCooperSurgical is a leading fertility and women’s healthcare company dedicated to supporting patients throughout their lifetimes. The Quality Control Inspector is responsible for inspecting components, subassemblies, and finished products to ensure compliance with approved specifications and regulatory requirements while maintaining product quality and safety.
Medical Device
Responsibilities
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
Qualification
Required
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
2+ years in medical device/healthcare manufacturing or quality inspection experience in an FDA-regulated environment
High School Diploma or GED required
Preferred
Certifications: ASQ Certification (Certified Quality Inspector or Certified Quality Technician) preferred
Benefits
Medical coverage
401(k)
Parental leave
Fertility benefits
Paid time off for vacation
Personal, sick and holidays
Multiple other perks and benefits
Company
CooperCompanies
CooperCompanies (Nasdaq: COO) is a leading global medical device company focused on helping people experience life’s beautiful moments through its two business units, CooperVision and CooperSurgical.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Agostino Ricupati
SVP Finance - Tax and Chief Accounting Officer
June White
Principal Business Partner, Inclusion & Diversity
Recent News
2024-05-04
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