Sr Design Quality Engineer
This position is responsible for various quality design engineering functions in support of development such as design assurance engineering activities, as well as manufacturing process development, risk management, design validation and verification, statistical analysis with an emphasis on Medical Devices single use devices, reusables and software.
Primary Duties and Responsibilities:
The following duties and responsibilities are intended to be representative of the work performed by the incumbent(s) in this position and are not all-inclusive. The omission of a specific duty or responsibility will not preclude it from the position:
Support and Lead Design Assurance engineering activities in support of Abiomed’s Product Development and Life Cycle processes including design controls, quality planning, risk assessments/analysis/management, design reviews, test method development and validation, design and process verification and validation test plans and reports, post-market monitoring, investigations, follow-up and reporting.
Ensure that Design controls are compliant with all relevant regulations (FDA, 13485, PMDA).
Assure complaince to ISO 60601.
Ensure that FDA and other regulatory knowledge and experience is applied to risk and testing assessments.
Work with manufacturing engineering to ensure necessary process controls are in place for design changes.
Review and approve Engineering Change Orders (ECO) and support the material review board (MRB) processes as needed.
Act as an effective team member in the execution of Quality functions in compliance with FDA QSRs (Design Control, CAPA, etc), ISO 13485, MDD, CMDR, CMDCAS and other national and international quality and regulatory requirements and standard.
Contribute to the design, development and implementation of product assurance plans providing feedback to corrective and preventative actions to engineering, manufacturing, service and field operations and supplier performance.
Develop statistically sound sampling plans and perform data analysis.
Assess reliability growth strategies in both systems and software and provide input to the engineering teams.
Bachelor degree in Engineering or Sciences is required, Masters preferred.
5+ years of quality experience.
Experience in the medical device industry as well as cardiovascular devices highly preferred.
Demonstrates strong knowledge of quality engineering policies, principles and best practices and FDA/ISO requirements.
Takes initiative and demonstrates leadership and team work.
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