Quality Assurance Manager

2 days ago

Minneapolis, Minnesota, United States Teleflex Full time
Quality Manager Job Description

Job Summary: We are seeking a highly skilled Quality Manager to oversee the development and maintenance of quality systems in our Plymouth, MN OEM facility.

Key Responsibilities:

  • Supervise and manage the development and maintenance of all plant quality systems, including supplier development, calibration, internal auditing, CAPA, quality engineering, and production support efforts.
  • Manage OEM complaint handling and establish compliance training programs.
  • Ensure that necessary regulatory corporate compliance systems are in place and adhered to.
  • Represent quality for new product development and provide statistical support as needed throughout the plant.
  • Serve as the Management Representative for the Plymouth MN OEM facility.

Requirements:

  • Bachelor's Degree in Engineering, Physical Science, or similar field.
  • Minimum 7 years of medical device industry experience, with contract manufacturing experience preferred.
  • Minimum 5 years of related quality experience in a manufacturing environment.
  • Minimum 3 years of supervisory or management experience.
  • ASQ CQA or CQE certification highly preferred.

Specialized Skills:

  • Strong leadership and management skills.
  • Demonstrated experience in mentoring and coaching others.
  • Contract Manufacturing, Regulatory, cGMP, QSR, knowledge base.
  • Statistical knowledge (DOE, SPC, hypothesis testing, sample comparison).
  • Strong computer skills (i.e. data-base development, statistical software and analysis, word processing for report generation, etc.).
  • Strong negotiation and problem-solving skills.
  • Ability to operate and communicate effectively with multiple teams.
  • Supplier auditing knowledge and ability (i.e. ASQ-CQA, internal/external courses, seminars).
  • Able to understand blueprints, tolerance analysis, and related knowledge.
  • Strong reasoning/analytical skills, including the ability to support and prioritize projects and adapt to shifting priorities.
  • Work with minimal supervision.
  • Able to successfully resolve problems and conflicts.

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