The Senior 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 leader or 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.
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.
Execution of both Internal and/or External supplier audits
Skills/Requirements
Job Qualifications:
BS in Engineering discipline (ME, Plastics or Biomedical); MS preferred.
8 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.
ASQ certifications (CQE, CRE, CQA) or Six Sigma Black Belt are a strong plus.
Clinical/field experience with catheter-based or cardiac assist devices is a plus.
Strong statistical / data analysis skills (e.g., Minitab).
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.
Must be proficient in Microsoft Office Suite. Working knowledge of SAP desired.
Abiomed (NASDAQ: ABMD) is a pioneer and global leader in healthcare technology and innovation, with a mission of RECOVERING HEARTS AND SAVING LIVES. Abiomed CEO, Chairman, and President, Michael R. Minogue, has focused the company’s efforts on developing ground-breaking technologies designed to assist or replace the life-sustaining pumping function of the failing heart. The Company’s portfolio of products and services offer healthcare professionals an array of choices across a broad clinical spectrum. From the world’s first total replacement heart to the World’s Smallest Heart Pump, 1/100th the size of the heart with rapid and simple insertion, Abiomed is dedicated to finding ways to bring the most advanced and beneficial technology to patients and physicians.
ABIOMED is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Veteran/Disabled.
