Manufacturing Quality Assurance Engineer

Join our onsite dynamic team at DEKA and be at the forefront of driving quality excellence! As our Manufacturing QA Engineer, you'll be a key player in our collaborative environment, working hand-in-hand with cross-functional teams to ensure the highest standards of quality and compliance.
As a Manufacturing QA Engineer you will contribute in the following areas:

• Perform in-process, final inspection, and related service activities while gaining an in-depth understanding of DEKA products and technologies.
• Collaborate with engineering team to drive timely inspections and process improvements. Ensure all manufacturing-related quality deliverables are met on-time and without compromising safety or efficacy.
• Facilitate the Material Review Board for the dispositioning of non-conforming materials, including cross-functional coordination and process improvements
• Initiate and drive investigation of corrective action, exception, and CAPA requests related to Manufacturing Quality.
• Review and approve quality records to ensure accuracy, completeness, and compliance with defined processes and adherence to GDP standards per ISO 13485 regulations.
• Develop trending and analysis of data for monthly reporting and management review meetings
• Support internal and external audits.

As a key contributor to our teams the following skills are required:

• Preferred BS degree in Engineering/Science with 3+ years of experience in Medical Device Manufacturing or a similar regulated industry (i.e. Aerospace, Defense, etc.)
  • or 7+ years of experience in medical device manufacturing in lieu of a degree
• Knowledge of FDA's Quality System Regulations (QSR's) and/or ISO 13485 and ISO14971
• Excellent interpersonal skills and the ability to effectively collaborate with others
• Broadly applicable knowledge regarding the design, development, and production lifecycles of a product
• Demonstrated ability to problem solve with a deep understanding of engineering fundamentals

About DEKA:

One hour from the beach, Boston, and the mountains, the historic Amoskeag Millyard once housed the largest textile mills in the world. It is now home to DEKA Research and Development, where we are taking the same innovation and cutting-edge technology into the modern age.

Behind DEKA’s brick walls sits a team of professionals who strive to make a difference every day through thoughtful engineering, design, and manufacturing. Here at DEKA, some of the most innovative and life-changing products of our time are created, and new ideas are always welcome and explored.

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