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Lead Quality Control Inspector

Company: Integra LifeSciences Corporation
Location: Boston
Posted on: March 28, 2025

Job Description:

Changing lives. Building Careers.Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.The Lead Quality Control Inspector will be responsible for all activities performed within the Quality Control Inspection team. This role also involves performing non-conformance investigations, identifying root causes, and contributing to the continuous improvement of processes.Works collaboratively with Manufacturing, Engineering, Quality Assurance, and other functional experts to support all daily operational activities. Consults with management to resolve quality, production, and efficiency problems. Functions in conjunction with Quality Control Inspection Supervisor and functional experts on special department projects. Performs the essential duties and responsibilities as listed in section below.ESSENTIAL DUTIES AND RESPONSIBILITIESTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

  • Collaborate with Quality Management to ensure all quality standards are met, including but not limited to ensuring all quality documentation is properly updated and completed in a timely manner.
  • Conduct inspections of products, processes, and systems to ensure compliance with quality standards.
  • Investigate non-conformances, identifying root causes, and implementing corrective actions.
  • Document and report quality control findings and support the analysis of data to recommend process improvements.
  • Conduct inspection and testing of raw materials, intermediates and recording of test results.
  • Assist as needed in test method validation, implementation, and execution.
  • Train employees in quality standards, KPIs and procedures.
  • Support the implementation of new or improved quality control systems as needed.
  • Ensure a working inventory of all department components, materials and solutions is maintained.
  • Perform root cause analysis and implement corrective actions.
  • Serve as a formal resource for colleagues with less experience.
  • Ensure compliance with industry regulations, company policies, and safety standards during the transition process.
  • Ensure database support, report generation and process data analysis.
  • Collaborate with Quality Management in preparing for and participating in FDA audits, customer audits, etc.
  • Ensure work areas and equipment are in a clean and orderly condition.
  • Must be able to work in a team environment, multi-task and communicate effectively.
  • Demonstrate excellent organizational and time management skills.
  • Knowledge of industry standards and regulations related to quality control.
  • Perform other duties as required.DESIRED MINIMUM QUALIFICATIONS:
    • High School Diploma with 5+ years of related work experience is required in a medical device, pharmaceuticals, Quality/Regulatory Compliance, or other regulated industry.
    • Associate or bachelor's degree preferred.
    • Familiarity with application of FDA and/or ISO quality standards in a government regulated industry.
    • Moderate computer competence, including experience with database and Microsoft Office software to create reports, spreadsheets, analyze data and prepare presentations.
    • Knowledge of QC terms, tools, and methodologies.
    • Working knowledge of standard laboratory practices and safety.
    • Ability to follow instructions precisely, recognize deviations, and recommend corrective action.
    • Detail-oriented.
    • The employee may be required to periodically lift and/or move up to 25 pounds.TOOLS AND EQUIPMENT USEDCalipers, rulers, dataloggers, standard office equipment (i.e. computers, phones, photocopiers, filing cabinets, other general office equipment).
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Keywords: Integra LifeSciences Corporation, Boston , Lead Quality Control Inspector, Other , Boston, Massachusetts

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