The Quality Engineer will be responsible for cross-functional Quality Assurance and Quality Engineering activities associated with all Abiomed products and processes.
Principle Duties and Responsibilities:
Provide Quality Engineering support in the design, development, market release, and post market release of single use medical implants and/or hardware (Product Specifications, Risk Assessments, V&V, etc.)
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
Represent Quality Assurance on Product Development Teams, Engineering Change Orders (ECO) and Material Review Board (MRB)
Act as an effective team member in the execution of Quality functions in compliance with FDA QSRs (Design Control, CAPA…), ISO 13485, MDD, CMDR, CMDCAS and other national and international quality and regulatory requirements and standard
Collect, analyze, interpret and report on quality system metrics: CAPA, complaint trends, manufacturing trends, etc.
Execution of both Internal and/or External supplier audits
Skills/Requirements
Job Qualifications:
BS in Engineering discipline (ME, Plastics or Biomedical); MS preferred
1- 5 years of experience in a Quality Engineering role in the medical device field
Demonstrated experience with formal problem-solving methodologies and deductive skills
Experience supporting the design and manufacture of disposable, consumable and/or implantable medical devices
Experience designing mechanical (implantable, consumable, disposable) medical devices is a plus
Clinical/field experience with catheter-based or cardiac assist devices is a plus
Strong statistical / data analysis skills (e.g., Minitab)
Six Sigma knowledge and/or demonstrated practical statistics knowledge is a plus
Ability to Communicate ideas and information clearly, effectively, and frequently (oral and written)
Ability to exercise judgment to determine methods, techniques and evaluation criteria for obtaining results
Execute tasks in a timely manner without direct supervision; Able to prioritize tasks
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.
