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Director of Quality Assurance

Position Summary Overview:

Develop and articulate strategic direction, oversight and alignment for all quality functions including Quality Assurance, Quality Control, Quality Engineering and Quality Systems. Determine and establish the Quality department’s organizational structure and supervisory relationships subject to Vice President’s approval. Select and develop key management and professional staff to ensure availability of resources to achieve organizational objectives and management continuity. Develop, communicate and build consensus for quality goals, objectives and programs that support division and company goals. Evaluate the Quality System to identify opportunities and improvements. Create short, mid and long range plans to carry out objectives established by top management. Forecast future departmental needs including human and material resources and capital expenditures. Ensure compliance with all applicable US and International regulatory requirements and standards pertaining to quality. Direct the quality function such that products meet quality expectations and are produced in compliance with medical device good manufacturing practices and quality system laws and regulations. Set direction to improve on product and process quality. Stay abreast of new or modified standards/regulations relevant to the Quality function; assess potential gaps in the quality system based on these changes and develop strategies to achieve compliance to these changes.

Responsibilities:

  • Direct, mentor and coach the Quality Department (Quality Engineering, Quality Assurance Lab, Quality Control and Quality Systems). Optimize organizational structure and staff.
  • Provide Quality leadership to the Company. Develop, communicate and build consensus for quality goals, objectives and programs. Create and execute strategic plans to carry out these activities.
  • Maintain Quality compliance and certification through the development and oversight of appropriate strategies, tactics and related activities.
  • Provide quality functional oversight for product development, manufacturing and external suppliers.
  • Serve as the Quality Systems Management Representative; lead quality management reviews and represent the Company during compliance audits by external groups such as US FDA and Notified Bodies.

 

Requirements:

  • Strong interpersonal relationship skills, team skills and organizational skills.
  • Proven ability to influence, coach and mentor.
  • Strong aptitude to solve problems of difficult scope and complexity.
  • Advanced written and oral communication skills and computer skills that include word processing, spreadsheet and Internet.
  • Ability to work closely and collaborate effectively with co-workers in various departments.

Generally a desk job in a standard office environment with standing and walking. Repetitive motion tasks associated with computer use.

Education, Experience and Skills Required:

  • Bachelor’s degree in Engineering or Science, Master’s in Engineering preferred.

  • At least 15 years in medical device industry involving medical device development and manufacturing.

  • Minimum of 7 years in Quality Assurance with experience creating and implementing systems for Quality.

  • At least 5 years of successful Quality managerial experience and ability to influence change.

  • •Medical device compliance experience with Class I, II and III devices.

  • Intimate knowledge of Quality System regulations and standards, e.g., ISO 13485:2003, QSR, 21 CFR 820, CMDCAS.

  • Extensive knowledge of analytical and quantitative aspects of Quality technology, Lean and Six-Sigma
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    Job Status:
    Full Time

    Travel:  Occasional travel including some overnight travel

    Compensation: DOE

    Job Location: St. Paul, MN 55114

    Contact Information:

    Lori Chmiel
    Senior Executive Recruiter
    952-847-3287
    Lori.chmiel@engageitresources.com