Negotiable
Job DescriptionDEKA RandD 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 and 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.Powered by ..... full job details .....
Negotiable