Quality Systems Representative - 30592BR - EN in Plymouth, MN at Stryker Corporation

Date Posted: 5/7/2018

Job Snapshot

Job Description

Founded in 2006, Entellus Medical delivers innovative, high quality, minimally invasive therapeutic solutions to healthcare providers and their patients who suffer from sinusitis. What makes Entellus Medical great? Our employees and the great products we offer.

It’s a great time to join our organization. We are in the process of uniting with Stryker and Spirox. Leveraging the unique competencies of our three strong organizations to better serve the industry will continue to set us apart from the competition. This type of growth enables us to truly address our customer’s needs and will help to position us as the market leader in the ENT space.

Together, with our customers, we are driven to make healthcare better. Join us…you have the opportunity to make significant impact with us!

Quality Systems Representative

Position Summary:
In this newly created role you will support the Quality System (all applicable documentation) and Quality Assurance projects.

  • Support the creation, revising, and reviewing all quality system documents within the site level.
  • Ensure compliance of all site procedures reviewed for format and content accuracy.
  • Review and coordinate the release of new or revised Divisional procedures.
  • Maintain the standard database and ensure site and divisional procedures are in compliance.
  • Support audit functions (internal and external audits) as required.
  • Support the coordination of any major changes to the quality system which may impact the structure, content, or its databases.
  • Support the coordination of the NC/CAPA and Complaint processes.
  • Conduct training on the Quality System for employees at various levels of the organization.

Job Requirements

  • HS diploma or GED required; bachelor’s degree preferred.
  • Experience working in Regulatory industry preferred.
  • Ability to understand regulatory requirements and translate into internal quality system documentation.
  • Excellent verbal and written interpersonal communication skills.
  • Effective analytical skills.
  • Organization, prioritization, and planning skills.
  • Strong PC skills including MS Office suite.
  • Ability to manipulate databases.
  • Must demonstrate the ability to problem solve.
  • Have fundamentals of project management.
  • Thrive in a fast paced work environment.

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