Quality Engineer II

Fujifilm-posted 3 months ago
$85,000 - $107,000/Yr
Full-time • Mid Level
Bothell, WA
Machinery Manufacturing
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The Quality Engineer II is responsible for assisting in establishing, implementing, and maintaining systems and/or services to measure and improve product quality, cost, and customer service while ensuring full compliance to FDA and applicable ISO requirements. The Quality Engineer II will be responsible for driving activity around process validation, as well as participating in establishing and monitoring systems related to Inspection, Testing, Training, Supplier Qualification, New Product Introduction, Manufacturing, Complaints, Reporting and Corrective/Preventative Action.

  • Innovative thinker, knowledgeable and intensely committed to ensure that products we supply conform to the FDA Quality System Regulation and ISO 13485.
  • Understands and can implement standard approaches to problem solving and prevention.
  • Participate in Configuration Management initiatives.
  • Support new product development in ensuring compliance with Quality System requirements.
  • Review/approve engineering changes on behalf of QA.
  • Participate in Corrective and Preventative activities.
  • Partner with R D and Operations in the development of verification and validation protocols for product designs and manufacturing processes.
  • Identify, plan, and participate in the implementation of process improvements.
  • Support Risk Management activities including Failure Mode and Effects Analysis.
  • Support the MRB process for discrepant material investigations and decisions.
  • Support Supplier Qualification and monitoring.
  • Review complex complaints and complaint trends and assist in failure investigations.
  • Support development and continuous improvement of quality system procedures.
  • Lead Quality related projects and Host Review Meetings.
  • Report to management on quality issues and trends.
  • BS or MS degree in Mechanical/Electrical/Industrial Engineering.
  • At least 2-4 years of experience working within the Quality organization of a Medical Device Manufacturer, Aerospace, Pharma, or other highly regulated industry.
  • Applications of Lean principles such as Value Stream Mapping, Standard Work, 5S, Kaizen.
  • Experience with domestic and overseas manufacturing and working directly with Contract Manufacturers and strategic vendors.
  • Experience with product lifecycle management (P/N creation, BoM creation, ECO generation and management, AVL management, etc.).
  • Quality engineering background and experience with AQLs, product inspections, vendor qualifications and audits.
  • Proficient in MS Office programs (Word, Excel, PowerPoint), Visio, MS Project; experience with document templates and scientific reference software is desirable.
  • Must be meticulous with strong written and oral communication skills.
  • $85,000.00 - $107,000.00/yr depending on experience.
  • Medical, Dental & Vision Insurance.
  • Life & Company paid Disability.
  • Retirement Plan (401k): 4% automatic Company contribution, Fujifilm matches 50 cents for every dollar you contribute, up to 6% of your salary.
  • Paid Time Off: You can accrue up to three (3) weeks of PTO in your first year of employment.
  • PTO increases based on years of service.
  • Employee Choice Holidays: Four (4) additional paid days off, based on date of hire in the calendar year.
  • Paid Holidays: Eight (8) paid holidays per year.
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