The Senior Quality Engineer is responsible for providing high level of hands-on technical quality engineering support for new programs and sustaining projects, internal nonconformances and external complaints investigation process.
Primary Duties and Responsibilities:
Review new and modified electromechanical and software design control documentation for quality characteristics, including manufacturability, serviceability, testability, reliability, and regulatory requirements.
Ensure that product development projects and changes to existing products are conducted in compliance with FDA Quality System Regulations.
Partner with electrical engineering and software engineering to develop product risk management file (risk management plan, risk assessments, DFMEA, and risk management report).
Review of customer complaints and CAPA investigations, ensuring that root cause investigations are thorough and corrective / preventive actions are robust.
Participates in the MRB and conducts and approves the necessary review of proposed disposition to identify/implement any required changes to the quality system or quality plan.
Review and approve change orders related to product/process changes, including approval of procedures and work instructions for manufacturing and inspection.
Participate when appropriate in internal GMP and supplier audits.
Identify quality assurance metrics; analyze and report trends to programs.
Provide product, project, and procedural guidance by anticipating product and manufacturing quality needs and implementing solutions to completion.
Skills/Requirements
Job Qualifications:
Masters degree in sciences and engineering plus 2 years of experience in electromechanical devices/ software firmware or Bachelors degree in sciences and engineering plus 5 years of experience in electromechanical devices /software firmware
Working knowledge of electronics, PCB, software control and user interfaces
ASQ CRE or CSQE is preferred, demonstrated application of reliability principles, and software verification principles
Familiar with IEC 60601, UL and other medical device product specific industry standards
Familiar with ISO 13485 quality system requirements and FDA quality system regulations 21CFR 820
Medical device industry experience is desired
Superior analytical, statistical, and communication skills (written, verbal and presentation)
Ability to work under time constraints
Ability to prioritize effectively and focus on results
ABIOMED is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Veteran/Disabled.
