Quality Design Assurance Engineer
Description / 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
Insure that FDA and other regulatory knowledge and experience is applied to risk and testing assessments
Investigation and review of customer complaints, ensuring that root cause investigations are thorough and corrective / preventive actions are robust
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
Collect, analyze & report on quality system metrics:
CAPA, complaint trends, manufacturing trends, etc.
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
Minimum of 3-5 years of quality experience in medical device industry in electro-mechanical systems and/or cardiovascular devices preferred
Demonstrates strong knowledge of quality engineering policies, principles and best practices and FDA/ISO requirements
Takes initiative and demonstrates leadership and team work
Softworld, Inc. Engineering