Job Description
DEKA R&D has an immediate opening for a Sr. Quality Engineer to work in the Quality Department in a dynamic Medical Device Research and Development environment. The position reports to the Director of Quality. We are seeking a Sr. Quality Engineer to provide quality guidance in a fast-paced medical device research, design assurance, manufacturing, and distribution environment.
How you will make an impact:
* Work cooperatively with cross-functional design team members and project management to ensure compliance with SOPs and regulations such as 21 CFR 820 and ISO 13485.
* Apply critical thinking to determine the best approach for quality assurance and compliance.
* Utilize experience in Design Assurance or medical device production to guide new product development.
* Lead and participate in Risk Management activities according to ISO 14971:2019, including developing Hazard Analyses, FMEAs, and other risk documentation.
* Ensure compliance with standards and regulations through engineering and technology expertise.
* Lead investigations to determine root causes and implement corrective actions using data analysis and problem-solving skills.
* Coordinate investigation efforts among teams and individuals.
* Provide guidance on Root Cause Analysis and CAPA based on manufacturing and monitoring experience.
* Maintain accurate documentation for communication with partners and regulatory bodies.
* Prepare work plans such as Master Validation Plans.
* Drive system and process improvements utilizing Six Sigma tools.
* Provide reliability and statistical analyses.
* Conduct test method validations.
* Participate in internal and external audits.
* Interface with partners on quality topics and evaluate proposed design or process changes.
* Manage supplier qualifications and corrective actions according to quality procedures.
* Facilitate review and approval of supplier-initiated changes and communicate them appropriately.
Required Skills & Experience:
* Bachelor’s degree in industrial, mechanical, or related engineering discipline.
* At least 5 years of experience in quality assurance related to medical devices.
* Experience with risk analysis and design transfer in medical devices.
* Knowledge of compliance standards such as 21 CFR 820 and ISO 13485:2016.
* Experience developing and leading quality system procedures.
* Support for regulatory submissions and participation in audits.
* Hands-on experience with supplier qualification, audits, and corrective actions.
* Ability to multitask, manage multiple data sources, and develop reports.
About DEKA:
Located in the historic Amoskeag Millyard, DEKA Research and Development combines innovation and cutting-edge technology to create life-changing products. Our team is dedicated to thoughtful engineering, design, and manufacturing, striving to make a difference every day.
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