Quality Engineer - Medical Device - Greater Boston Area
Seeking a Quality Engineer looking to be an impact player on the Quality team
This client is Global market leader for its type of device
About Our Client
This company is a market leader in class 1 & class 2 medical device. They have grown significantly from the smaller company they were a few years ago and are looking to expand.
- CAPA - Conduct failure investigations, root-cause analysis, and corrective action implementation. Provides leadership and technical expertise for effective Root Cause Analysis
- Provide Quality Engineering support to New Product Development Projects - Support Risk Management activities, lead review and updates to Risk Management File.
- ISO 13485, ISO9001
- Develop and implement quality improvement with working knowledge of Quality standards and systems.
- SOME domestic travel mainly within the first year only (up to 10%)
- Support Manufacturing Lean initiatives.
- Participate/ Lead project teams and attend board meetings.
The Successful Applicant
- 2+ years related experience in a regulated environment
- B.S in Science or Engineering
- Trained Lead Auditor preferred
- Background in Medical Device needed
- Experience in Supplier Quality desired
- Strong oral and written communication skills
What's on Offer
- Competitive Compensation
- Team Oriented Work Environment
- Structured Growth Plan
- Bonus opportunity
- Strong benefits package - medical dental vision etc.