DEKA R&D has an immediate opening for a Quality Engineer to work in the Quality Department in a dynamic Medical Device Research and Development environment.  The position reports to the Quality Manager.  We are seeking a Quality Engineer to provide Quality guidance in a dynamic, fast-paced medical device research, development, and manufacturing and distribution environment.

How you will make an impact:

• Work cooperatively with cross functional design team members and project management to determine the best approach for on-going compliance with applicable SOPs and regulations, such as 21 CFR 820 and ISO 13485

• Participate in and lead Risk Management activities in accordance with ISO 14971

• The development, implementation, and approval of Hazard Analyses, FMEAs, and other Risk Analysis documentation.

• Lead investigations including root cause identification, corrective actions, and verification of effectiveness, through use of data analysis, inductive and deductive reasoning, and problem solving skills.

• Coordinate the efforts of individuals and teams performing investigations.

• Use experience within manufacturing and monitoring of medical devices, to provide guidance in Root Cause Analysis and CAPA.

• Use experience with engineering and technology to identify and ensure compliance with applicable standards and regulations.

• Ensure the accurate documentation / recording of information to be used in communication with partners and regulatory bodies.

• Prepare detailed work plans and procedures such as Validation Plans.

• Evaluate and approve proposed design or manufacturing process change.

• Drive system and process improvements.

• Provide reliability and statistical analysis.

• Participate in internal and external audits.

How you will be successful in this role:

• Bachelor’s degree in an engineering or related STEM discipline. Additional training and experience may be considered in lieu of degree.

• Minimum 2-5 yrs. of experience as QE in a regulated manufacturing environment.

• Must be detail oriented and have strong communication both written and verbal.

• Experience with compliance, with applicable standards and regulations such as 21 CFR 820, ISO 13485, and ISO 14971 is preferred.

• Ability to:

• Multitask and carry tasks through to completion

• Manage multiple sources of data and develop reports

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 & 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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