Quality Engineer III
Fujifilm
- Bothell, WA
- $110,000 per year
- Permanent
- Full-time
- Innovative thinker, knowledgeable and intensely committed to ensure that products we supply conform to the FDA Quality System Regulation and ISO 13485.
- Takes lead of implementing standard approaches to problem solving and
- prevention. Devises creative approaches to solving problems encountered.
- Take lead on new product development in ensuring compliance with Quality System requirements.
- 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.
- Oversee Risk Management activities including Failure Mode and EffectsAnalysis.
- Lead the MRB process for discrepant material investigations and decisions.
- Support supplier qualification and monitoring.
- Review complex complaints and complaint trends and participate in failure investigations.
- Support development and continuous improvement of quality system procedures.
- Report to management on quality issues and trends.
- Available to be on calls in the morning or evening with global contract manufacturers and suppliers in other time zones.
- BS in Mechanical/Electrical/Industrial Engineering or equivalent experience required.
- At least 4-7 years of experience working within a Medical Device Manufacturer.
- 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.).
- 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 detail-oriented with strong written and oral communication skills.
- Ability to travel 10% domestically and internationally as needed.
- $78,0000 - $110,000 depending on experience + variable pay opportunity
- Insurance:
- Medical, Dental & Vision
- 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