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Senior Quality Engineer, Medical Device
- BS in Engineering highly preferred
- Growing medical device company with excellent leadership team
About Our Client
This company is a contract manufacturing medical device company located near Franklin, MA. While it is a smaller organization, the atmosphere is friendly and collaborative and boasts a very strong learning environment. This company is quickly becoming well known for its top quality products. Due to growth, company is looking for a Senior Quality Engineer to assist in mentoring others and lead technical quality issues.
The Senior Quality Engineer will participate in directives that include:
- Provide guidance to engineering staff and other personnel and ensure that design control requirements are being met in an effective manner, including those for design verification, validation, specification and procedure development, risk management, and design review.
- Identify and manage corrective actions relating to Design History Files for commercialized product
- Familiar with components of the design history file, development phase deliverables and how they are inter-connected.
- Identifies and manages risk throughout the development process with the use of FMECA and/or other risk management tools.
- This includes leading the Risk management efforts of the design process and working with design team and management team on managing product and process risks.
- Provides input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested.
The Successful Applicant
The Senior Quality Engineer should have:
- BS in Engineering Degree
- 4+ years of experience in quality engineering
- Initiative and desire to learn
- Excellent communication skills, both written and verbal
What's on Offer
- Great team environment
- Opportunity to learn within medical device
- Competitive compensation package
- Work/Life balance