Quality Manager

2 weeks ago

Minneapolis, United States EPM Scientific Full time

As a Quality Manager, you will lead and manage the Quality team and resources to ensure company compliance with internal Quality Management Systems. Additionally, you will oversee engineering activities that support both sustaining manufacturing operations and product development programs.


Responsibilities:

Key areas of expertise include:

  • Quality System Oversight: Ensure the company's Quality Management System (QMS) is compliant, and establish and maintain processes that align with relevant regulations and standards.
  • Regulatory Compliance: Promote awareness and adherence to regulatory requirements and QMS standards throughout the organization.
  • Management and Reporting: Lead Management Review meetings, report on QMS performance, drive continuous improvements, and analyze relevant quality metrics.
  • Quality Control Management: Oversee Quality Control staff, manage inspection activities, and supervise complaint analysis and corrective/preventive actions.
  • Cross-Functional Leadership: Provide guidance, leadership, and coaching to Quality personnel and cross-functional teams, supporting Quality initiatives during product development phases.
  • Risk Management and Documentation: Assist in creating and updating risk management documentation, perform qualifications/validations, and contribute to process and design change activities.
  • Audits and Compliance: Manage external audits, regulatory certifications, and support document control and record retention processes.
  • Continuous Improvement: Lead initiatives for corporate QMS enhancements, promote best practices, and ensure compliance with current good manufacturing practices (cGMP).
  • Metrology and Calibration: Manage metrology and calibration activities to ensure accuracy and regulatory compliance.
  • Nonconformance and Training: Oversee nonconformance reviews and ensure that Quality Systems staff are trained in Documentation Control, Inspection, Complaint Analysis, and Corrective Action processes.
  • Development and Transfers: Maintain accountability for Design Controls and DHF (Design History Files) management, support development programs, and collaborate with cross-functional teams.
  • Safety and Compliance: Ensure adherence to company policies, safety protocols, and quality standards.


Must Have:

  • A Bachelor's degree in Science, preferably in an engineering discipline, or equivalent combination of education and experience.
  • At least 7 years of experience in a regulated medical device environment, preferably in a Senior or Principal Quality Engineer or Quality Manager role, with supervisory and decision-making responsibilities.
  • Quality and/or Regulatory certification(s) preferred (e.g., ASQ, Lead Auditor).
  • In-depth knowledge and experience with external standards and regulations: ISO 13485, 21 CFR 820 (FDA cGMP/QSR), and EU MDR, particularly in product development, design controls, good manufacturing practices, supplier auditing, and management.
  • Experience with Class II and Class III medical device development and manufacturing.
  • Proficiency with Manufacturing Process tools and methodologies, including Process Change Assessment, Risk Management (Hazard Analysis), Process FMEA, Statistical Analysis, Process Qualification, Gauge R&R, and Inspection/Test Method Validation.

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