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Senior Quality Engineer

Location: MN - Minneapolis
Position ID: P0006977

Description

POSITION SUMMARY:    

The Sr. Quality Engineer develops, practices, and promotes quality principles throughout the organization to achieve defined customer quality requirements and required regulatory compliance.  In addition, this individual provides leadership and guidance to the organization to maintain compliance with QSR and ISO certification. 

All positions are responsible for following applicable AMS policies and procedures as defined by their manager.

PRINCIPAL DUTIES AND RESPONSIBILITIES:  

Product Development Engineering Support

  • Participate as a core team member and provide risk management support and follow-up.
  • Develop and lead quality plan initiatives to support new product development activities
  • Support and/or conduct verification and validation testing.

Systems Support

  • Independently identifies and implements improvements to the quality and effectiveness of products and processes.
  • Facilitates Quality initiatives to assure compliance to QSR/ISO throughout the company.

Continuation Engineering Support

  • Develop and lead quality plan initiatives to support sustaining activities related to active products
  • Facilitate post market surveillance activities as requested

Supplier Support

  • Leads efforts in evaluating and developing suppliers for certification; acts as a liaison between R&D, and suppliers to assure specifications are appropriate and achievable.

Team Support

  • Supports project teams.  Promotes implementation of quality principles at all phases of product development.
  • Independently identifies and implements improvements to the quality and effectiveness of products and processes.

Technical Support

  • Supports investigation, prioritization and coordination of proposed documentation changes.
  • Provides technical assistance for incoming inspection and manufacturing quality problems.
  • Selects and applies appropriate statistics techniques for testing of materials and incoming components.

QUALIFICATIONS: 

Education:

  • Bachelor’s degree in Science, Engineering or equivalent experience

Experience: 

  • Minimum of seven years medical device and/or drug manufacturing/quality systems

Skills:

  • Comprehensive knowledge of quality system standards and regulations (e.g., FDA QSR, ISO 13485)
  • Strong background in statistical techniques, measurement tools and SPC tools
  • Ability to work both independently and in partnership with others
  • Ability to read and interpret drawings and design specifications
  • Proficient in technical writing
  • Strong verbal and written communication skills
  • Basic project management skills helpful

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this position. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.  Management reserves the right to change or modify such duties as required. 

*LI-MM




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