Senior Quality Assurance Manager

4 weeks ago


Massachusetts, United States BioTalent Full time

BioTalent is seeking a seasoned professional to lead our Quality Control Program and ensure the highest standards of quality in our laboratory equipment components and complete devices.

**Key Responsibilities:**

  • Provide strategic leadership to ensure all products, raw materials, processes, and services meet BioTalent's exceptionally high-quality standards.
  • Ensure company compliance with accredited quality systems, including 21 CFR part 820, ISO 13485, and applicable EU, UK, and Australian requirements.
  • Continuously evolve and improve the company's quality system, adapting to revisions of standards and ensuring seamless transitions.
  • Lead company audits by accreditation bodies or customers, ensuring a high level of quality and compliance.
  • Collaborate with teams to identify and address quality issues, preventing repeat errors and maintaining a culture of continuous improvement.
  • Maintain and communicate quality data to department managers, facilitating problem identification, resolution, and loss reporting.
  • Report company quality data, including complaints, nonconforming product, and corrective/preventive action activities.
  • Review non-conformities (NCRs) to determine root cause, create corrective actions, and provide customer follow-up, closing NCRs within an acceptable timeframe.
  • Conduct problem-solving tests to develop corrective actions for quality issues and drive continuous improvement.
  • Perform routine quality checks on the production floor, reporting errors and process improvement recommendations.
  • Coordinate returns to vendors and ensure corrective actions are in place to prevent future defects.

**Minimum Requirements/Qualifications:**

  • Bachelor's degree from an accredited higher learning institution, preferably in a Quality or Engineering-related field.
  • Experience in high-volume manufacturing environments, preferably in medical devices or in-vitro diagnostics.
  • Experience with European IVDD and IVDR compliance and regulations.
  • Experience with FDA 21 CFR Part 820 regulations.
  • Minimum of 10 years' experience related to quality assurance, lean manufacturing, regulatory compliance, and/or Six Sigma manufacturing.
  • Holds Quality certifications in one or more of the following: ASQ/CQE, CMQ/OE, Six Sigma (Green or Black Belt).


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