Quality Assurance Manager

3 days ago

Albany, New York, United States Michael Page Full time
Quality Control Manager - Medical Device Manufacturing

Are you a seasoned Quality Control professional seeking a new challenge in the Medical Device industry? Do you have a proven track record of leading high-performing teams and driving quality excellence? If so, we encourage you to apply for the Quality Control Manager - Medical Device Manufacturing role at our client's facility near Rochester, NY.

Key Responsibilities:
  • Develop and implement quality control policies, procedures, and protocols to ensure compliance with regulatory requirements (FDA, ISO 13485, CE marking, etc.).
  • Plan and oversee QC activities across all stages of the product lifecycle (incoming materials, in-process, and final product inspections).
  • Lead, mentor, and develop a team of QC inspectors, technicians, and engineers.
  • Ensure proper training and continuous development of QC personnel to stay updated on industry best practices and regulatory changes.
  • Oversee routine inspections and audits of raw materials, in-process materials, and finished products to ensure compliance with specifications.
  • Manage the implementation of quality testing (functional, dimensional, and safety testing) for new and existing products.
  • Ensure proper calibration and maintenance of QC equipment and tools.
  • Maintain accurate and up-to-date documentation of QC activities, including inspection reports, non-conformance reports (NCRs), and corrective/preventive action plans (CAPAs).
  • Lead internal audits and support external regulatory inspections.
  • Ensure compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable regulations and standards.
  • Investigate and resolve quality issues, including non-conformances, product failures, and customer complaints.
  • Implement corrective and preventive actions (CAPA) to address root causes of quality issues.
  • Collaborate with cross-functional teams (engineering, manufacturing, regulatory, etc.) to implement process improvements and enhance product quality.
  • Conduct risk assessments (e.g., Failure Mode and Effects Analysis - FMEA) and implement risk mitigation strategies.
  • Monitor key quality metrics (KPIs) and develop strategies to reduce defects and improve production efficiency.
  • Manage supplier quality control programs, including the qualification, monitoring, and auditing of suppliers.
  • Ensure that all supplied components and materials meet the company's quality standards and regulatory requirements.
Requirements:
  • Bachelor of Science in Mechanical Engineering, Industrial Engineering, or a related field.
  • Managerial experience required.
  • 5+ years of experience within a Medical Device Manufacturing Company or a related industry.
  • Document Control experience required.
  • ISO 13485 knowledge.
  • Ability to wear many hats and work in a fast-paced environment.
What We Offer:
  • Base Salary of $100,000-$125,000 depending on experience.
  • Bonus.
  • 401K Match.
  • Health, Dental, Vision.
  • PTO.

Michael Page is an equal opportunities employer and welcomes applications from diverse candidates. We are committed to creating an inclusive work environment that values diversity and promotes equal opportunities for all employees and job applicants.

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