Quality Engineer - New Product Development
11911 North Creek Parkway South Bothell, WA 98011
Position Title: Quality Engineer
Position Description: Protingent Staffing has an exciting direct hire opportunity with our client in Bothell, Washington for an experienced Quality Engineer. This candidate will need a minimum of 2 yrs. of NPD Quality experience. An EE or ME background is ideal.
- Support design and process changes for current product and provide input and approval of qualification protocols and reports.
- Assist product development teams with activities such as design requirements, verification testing methods, reliability analysis, protocols and reports, and help ensure the team is in compliance with applicable processes and regulations.
- Lead or participate in risk management activities following ISO 14971 with tools appropriate for various stages of the product life cycle including FMEA, PFMEA, and Use Error Hazard analysis.
- As assigned, participate or lead electrical compliance certification process for IEC 60601-1 third edition including ISO 62304 software compliance activities
- Prepare and analyze quality metrics as needed for Quality Management Reviews or as deemed necessary to assist in identification of failure trends.
- Participate in the creation, implementation, and teaching of new or improved quality system processes.
- Responsible for QA activities such as material bio-compatibility testing and sterilization validations as assigned.
- Support equipment and process validation (IQ/OQ/PQ) by participating in the development of studies and validation protocols to assess manufacturing capability/reliability.
- Perform or coordinate failure investigations and prepare failure investigation reports.
- Recommend, plan and lead assigned corrective and preventive actions for continuous improvement.
- Participate in complaint investigations, complaint closure, analysis of complaint trends, and other complaint department activities as needed.
- Conduct nonconforming material investigations and dispositions as required.
- Must have BS degree in Engineering or equivalent degree/experience
- Minimum two (2) years quality engineering experience on the development side of the medical device industry. Ideally an EE or ME background.
- Direct experience with FDA QSR, MDD & ISO 13485 compliance for manufacture of medical devices
- Working knowledge of Design Controls and ISO 14971 Risk Management best practices
- Strong verbal communication skills and effective writing skills required
- Ability to excel in a team oriented environment
- Certified Quality Engineer (CQE), Certified Reliability Engineer (CRE), or Six Sigma Black Belt (CSSBB) status desired
About Protingent: Protingent is a niche provider of top Engineering and IT talent to Software, Electronics, Medical Device, Telecom and Aerospace companies nationwide. Protingent exists to make a positive impact and contribution to the lives of others as well as our community by providing relevant, rewarding and exciting work opportunities for our candidates.
I have worked in Technical staffing for over 17 years in the Pacific NW primarily, and Nationally. My specialty is finding candidates for contract, contract to hire and direct hire jobs in Technical & Engineering fields for some of the greatest Hardware & Software product development companies around. I listen to what you are looking for and will ensure your resume looks great. I am honest and communicative throughout the hiring process. I am passionate about putting our Veterans back to work, and helping underrepresented people get into STEM careers.