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POSTED 04/16/2021

Quality Manager

Location: Eden Prairie, MN
 
Currently looking for skilled individual for a Quality Manager opening with a company located in Eden Prairie, MN. Interested candidates should have experience working in the medical device industry, knowledge of ISO 13485 with excellent leadership skills.
 
Quality Manager Job Description:
  • Head or support oversight to all of Quality Procedures, review yearly and improve to support overall compliance to ISO 13485 standards.
  • Creates and maintains Quality documentation to support Customer requirements and regulation.
  • Create, review, and approve Document Change Orders (i.e. change control management).
  • Create, review, and approve COAs and COCs as required.
  • Create/maintain/track and report all Quality System Site Management Review Metrics as required.
  • Investigate and resolve product and process complaint nonconformities.
  • Manage CAPA programs including any/all other Quality Programs as required.
  • Lead investigation of product, services, or internal business processes in order to identify and correct issues causing non-compliance of product to specification.
  • Perform, direct, and support internal and external audits of the quality system.
  • Help with Regulation implementation and filing requirements.
  • Performs other duties as requested.
  • Perform quality control testing of combination drug products
  • Perform lab investigations
  • Create new and improved quality systems
  • Provide main Customer communications
  • Risk management planning and reporting
  • Support regulatory filings such as MAFs
  • Stability and shelf life testing
  • Perform other quality control testing duties as required
  • Support the quality department design controls for new products
  • Supervise Quality Technicians and Specialists
 
Quality Manager Job Requirements:
  • BS degree in Engineering, Biology/Microbiology, Chemistry or Life Science or a combination of 7-10 years working in a medical device or related industry.
  • Understand and apply knowledge of ISO 13485:2016. Ideally, experienced working in an established FDA Quality System Regulation (QSR- 21 CFR Part 820, 21 CFR Part 210/211).  
  • Technical writing within the medical device space.
  • Good laboratory practice (cGLP) and good manufacturing practice (cGMP) exposure.
  • Analytical problem solving skills with a demonstrated ability to resolve complex issues.
  • Effectively use risk-based decision-making.
  • Ability to collect, summarize and report technical information. 
  • Computer competency in MS Office - Word, Excel, and Outlook.
  • Integrity and high ethical standards.
  • Excellent verbal, interpersonal and written communication skills.
  • Self-starter, and motivated individual who can works independently and coach/mentor on best practices as needed.
  • Experience working with contract manufacturing, chemistry manufacturing and capital equipment.  Familiar with engineering and/or analytical chemistry methodology.
  • Experience with developing test method validation, process validation and equipment validation.
  • Desire to learn and grow with company and to help take the company to the next level.
  • Ability to lift up to 40 pounds.
  • Manual dexterity.
  • Ability to reach overhead and extend arms completely.
  • Ability to stand for long periods of time.
 
Compensation for Quality Manager:
The starting salary for the 1st Shift Quality Manager position is $90k per year.
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