The Principal Quality Engineer will engage and drive quality and quality related engineering initiatives on product development and manufacturing projects for the Mechanical Engineering department 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.
Lead multi-functional post-market release teams to address and resolve specific quality issues.
Act as an effective leader or 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
Job Qualifications:
BS degree in mechanical engineering. MS Preferred.
12 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 desired.
ABIOMED is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Veteran/Disabled.
