Quality Control Inspector II jobs in United States
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CooperSurgical · 10 hours ago

Quality Control Inspector II

CooperSurgical 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.

Health CareMedical DeviceWomen's
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H1B Sponsor Likelynote

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

CGMP knowledgeFDA regulations knowledgeISO 13485 knowledgeInspection tools proficiencyEngineering drawings interpretationMicrosoft Office proficiencyQuality inspection practicesTroubleshooting skillsCAPA activities supportAttention to detailOrganizational skillsCommunication skillsProblem-solving skills

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

CooperSurgical

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CooperSurgical provides a full portfolio of medical and surgical products. It is a sub-organization of The Cooper Companies.

H1B Sponsorship

CooperSurgical has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (8)
2024 (10)
2023 (10)
2022 (13)
2021 (5)
2020 (4)

Funding

Current Stage
Late Stage

Leadership Team

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Lisa Fawcett
Executive Vice President, Strategy & Market Development
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Company data provided by crunchbase