Quality Control Inspector II

CooperCompanies•Trumbull, CT

5d•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

ASQ Certification (Certified Quality Inspector or Certified Quality Technician) preferred.

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.