Quality Manager

  • Poulsbo, WA
  • $65,000 - $85,000
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A bit about us:

We have over 60 years’ experience as a leading manufacturer of medical devices and specialist healthcare products.

Why join us?

We offer employer sponsored health plans. Corporate paid life and disability insurance. 401k Match up to 5% with 3 year vesting period. Education reimbursement and employee discount program.

Job Details

Your Role:
  • Plan, direct, or coordinate quality assurance programs and production activities for our medical device and commercial machining divisions
  • Ensure compliance with regulatory processes, such as internal audits, inspections, license renewals, or registrations
  • Schedule and lead all external and internal ISO 13485, ISO 9001, and AS9100 audits
  • May compile and prepare materials for submission to regulatory agencies
  • Establishing, maintaining, and improving the Quality Management System; directing work of others
  • Responsible for Metrology Lab – all equipment and processes including CMM & Laser Tracker programming/operation, document control, and departmental metric
  • Hiring, developing, and performance management of a team of quality professionals

Education/ Experience:

  • Bachelor’s Degree in Manufacturing, Technical, Science, or Engineering discipline and at least one year of professional experience in regulatory affairs or in quality management systems; OR four years of professional experience in regulatory affairs or in quality management systems position, preferably relating to medical devices.
  • Track record of success leading teams through regulatory audits for ISO 13485, ISO 9001 and AS9100 Rev.D
  • Knowledge of FDA submission and approval process
  • Proficient with Microsoft Office Suite
  • Experience with MRP system, preferably SAP; ProShop
  • Working knowledge of global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO13485;2016, ISO14971, European Medical Device Directive [MDD], new Medical Device Regulation [MDR], and FDA GMP

Personal Qualifications:
  • Entrepreneurial spirit
  • Quality mindset
  • Independent & Self-Sufficient leader
  • Highly organized and detail oriented
  • Dynamic/flexible personality
  • Excellent verbal and written communication skills capable of interacting with a variety of audiences and professions

Must be a U.S. citizen or national, U.S. permanent resident (current Green Card holder), or lawfully admitted into the U.S. as a refugee or granted asylum.

Easy Apply Now
Easy Apply Now
Job Details
Poulsbo, WA
Job Type
$65,000 - $85,000