DEKA Research & Development
Project Quality Engineer
DEKA Research & Development, Manchester, New Hampshire, us, 03103
We are seeking a Project Quality Engineer to provide Quality Leadership on a dynamic, fast paced medical device research and development team.
How you will make an impact as a Project Quality Engineer:Work cooperatively with cross functional design team leads and project management to determine the best approach for on-going compliance with applicable SOPs and regulations, such as 21 CFR 820 and ISO 13485:2016.Use experience within product development or production of medical devices, to provide guidance and assistance in the development of new products.Use experience with engineering and technology to identify and ensure compliance with applicable standards and regulations.Participate in and lead Risk Management activities in accordance with ISO 14971:2019, such as:
Reviewing and approving Risk Management Plans.The development, implementation, and approval of Hazard Analyses, FMECAs, and other Risk Analysis documentation.Support risk analysis during product anomaly reviews.
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.
Assist in the development, review, and approval of Design History File documentation:
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 Anomaly Management Plans.Evaluate and approve proposed design changes.Drive quality as a culture through system and process improvements.Provide reliability and statistical analysis.Participate in internal and external audits.Interface with partners on quality topics.How you will be successful in this role:
Bachelor’s degree in an engineering discipline
A degree in a related STEM discipline (Physics, mathematics, etc.) may be considered with sufficient professional experience.
Minimum 5-8 yrs. of experience in Medical Device Quality Engineering
Experience in new product development strongly preferred.
Experience with compliance, with applicable standards and regulations such as 21 CFR 820, ISO 13485:2016, and ISO 14971:2019 required.
Experience supporting EU fielded product is a plus.
Experience developing and leading quality system procedures required.Experience with direct responsibility for Risk Analysis and Design Transfer is preferred.Experience supporting regulatory body submissions preferred.Experience participating in internal and external audits preferred.
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How you will make an impact as a Project Quality Engineer:Work cooperatively with cross functional design team leads and project management to determine the best approach for on-going compliance with applicable SOPs and regulations, such as 21 CFR 820 and ISO 13485:2016.Use experience within product development or production of medical devices, to provide guidance and assistance in the development of new products.Use experience with engineering and technology to identify and ensure compliance with applicable standards and regulations.Participate in and lead Risk Management activities in accordance with ISO 14971:2019, such as:
Reviewing and approving Risk Management Plans.The development, implementation, and approval of Hazard Analyses, FMECAs, and other Risk Analysis documentation.Support risk analysis during product anomaly reviews.
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.
Assist in the development, review, and approval of Design History File documentation:
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 Anomaly Management Plans.Evaluate and approve proposed design changes.Drive quality as a culture through system and process improvements.Provide reliability and statistical analysis.Participate in internal and external audits.Interface with partners on quality topics.How you will be successful in this role:
Bachelor’s degree in an engineering discipline
A degree in a related STEM discipline (Physics, mathematics, etc.) may be considered with sufficient professional experience.
Minimum 5-8 yrs. of experience in Medical Device Quality Engineering
Experience in new product development strongly preferred.
Experience with compliance, with applicable standards and regulations such as 21 CFR 820, ISO 13485:2016, and ISO 14971:2019 required.
Experience supporting EU fielded product is a plus.
Experience developing and leading quality system procedures required.Experience with direct responsibility for Risk Analysis and Design Transfer is preferred.Experience supporting regulatory body submissions preferred.Experience participating in internal and external audits preferred.
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