Quality Engineer

DEKA Research & Development•Manchester, NH

55d•Onsite

About The Position

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.

Requirements

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.
Ability to multitask and carry tasks through to completion.
Ability to manage multiple sources of data and develop reports.

Nice To Haves

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

Responsibilities

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.