The Senior or Principal Quality Engineer will engage and drive quality and quality related engineering initiatives on product development and manufacturing projects as well as for post-market safety activities including the evaluation of product complaints, investigation and resolution of post-market related product issues, product trending and periodic reporting.
Primary Duties and Responsibilities:
Responsible for developing and executing quality and risk plans to ensure requirements are met during product development and product launch
Work closely with suppliers and various internal functional groups in areas of quality including process development and the corrective actions
Responsible for 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
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.
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, interpret and report on quality system metrics: CAPA, complaint trends, manufacturing trends, etc.
Execute both Internal and/or External supplier audits
Develop statistically sound sampling plans and perform data analysis
Skills/Requirements
BS degree in engineering or scientific discipline required; MS preferred
5+ years of experience in a Quality Engineering role in the medical device industry
Experience supporting the design and manufacture of disposable, consumable and/or implantable medical devices
Demonstrated experience with formal problem-solving methodologies and deductive skills
ASQ, CQE, CRE, CQA and/or Six Sigma Black Belt preferred
Strong statistical / data analysis skills (e.g., Minitab)
Ability to Communicate ideas and information clearly, effectively and frequently (oral and written)
Ability to exercise independent judgment in methods, techniques and evaluation criteria for obtaining results
Ability to act independently to determine methods and procedures
Must be proficient in Microsoft Office Suite; Working knowledge of SAP is desired
ABIOMED is an Equal Employment Opportunity/Affirmative Action employer. We are committed to the policy of providing equal employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, veteran status, disability or national origin.