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- Manchester, NH
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Senior Quality Engineer - Process Validation
DEKA Research & Development Corp. • Manchester, NH
Posted 1 month ago
DEKA employs a team of over five hundred professionals, whose engineering, design, manufacturing and quality expertise make DEKA a hot spot for creating innovative solutions and advanced technologies. Located about an hour from Boston, the beach, and the mountains, DEKA is one of the leading research and development companies in the country and is the birthplace of some of the most innovative and life-changing products of our time
We’re in search of a Senior Quality Engineer to lead Manufacturing Quality operations in a dynamic, fast paced medical device research, development, and manufacturing environment. This role is the crucial link from design to manufacturing and will have high visibility within our organization. This is a terrific opportunity to utilize your quality skills on a dedicated team that strives to create solutions to improve the lives of many. Are you passionate about making a positive impact on the world? Do you want to make a difference with your work? At DEKA you can.
How will you contribute?
- Work with Project Managers and leads to transition products from development into a manufacturing environment, for internal and external customers, including Design Transfer and Manufacturing Process Validation (Installation Qualification, Operation Qualification, and Performance Qualification)
- Provide guidance and assistance on manufacturing processes for new and existing manufacturing lines
- Assist in the creation of PFMEAs and Control Plans for manufacturing processes
- Participate in the creation of Device Master Records (DMR) and Device History Records (DHR)
- Responsible for the maintenance of Device History Record and ensuring tracking and configuration is maintained
- Manage the Material Review Board (MRB) meetings and ensure the timely resolutions of nonconformities
- Lead EN ISO 13485 audits and contribute in FDA and other regulatory inspections for their respective area(s)
- Manage Quality System procedures for manufacturing QA operations and MRB
- Other responsibilities as required, including the potential for managing exempt and/or non-exempt employees
What does our ideal candidate have?
- B.A or B.S. in relevant technical field or equivalent; MS in Engineering desired but not required
- At least 3 years’ of applicable process quality/design transfer experience. Medical Device field is preferred
- Knowledge of and experience being audited to 21 CFR 820 and ISO 13485 (2016 preferred)
- CQA and/or CQE desired but not required
- Demonstrated organizational and time management skills including the ability to work on many projects simultaneously
- Detail oriented but have the ability to maintain the big picture
- Good oral and written communication skills
- Computer and database skills and knowledge