ISO 13485 Registered

Employment Opportunities

Sr. Quality Engineer

Stellartech is looking for a Senior Quality Engineer to join our QA Team.

Responsibilities:

  • Perform quality engineering development activities for new product designs by assisting Engineering in the preparation of design and development plans, Design History File documentation, and Design History File preparation.
  • Review and approve Device Master Record documentation for new product design and maintenance, including: bills of material, assembly procedures, manufacturing operations, assembly diagrams, test procedures, component specifications, labeling, and operator’s manuals.
  • Perform ongoing quality engineering activities on current products to improve product designs and/or manufacturing processes including participation in NCM, Complaint, and CAPA investigations and actions as necessary.
  • Assist in process validation activities for new and current products.
  • Assist in maintenance and improvement of the Quality System with guidance of QA Management, including internal audits, external audits, and quality improvement activities. 
  • Assist Engineering in the preparation and execution of verification and validation protocols and verification and validation test reports for new products and changes to current products.
  • Participate in Hazard Assessment, Failure Mode and Effect Analysis, and risk management analysis, as required, for new and current products.
  • Participate in external safety test agency testing and preparation of Risk Management file and checklists.
  • Participate in usability engineering and assist engineering with the creation of usability engineering file documents.
  • Perform quality engineering activities for design changes to existing product designs by assisting engineering in the preparation of plans and DHF documentation.
  • Perform an IEC 62304 audits for software development activities.
  • Assist manufacturing in NPI activities.
  • Create SOP’s and update exiting SOP’s.
  • Participate in and/or conduct design reviews.
  • Assist in the preparation of regulatory submissions to the U. S. FDA and other regulatory agencies.
  • Review and approve Device History Records for finished device release as required.
  • Serve as a technical resource for technicians, assemblers, and other Stellartech personnel.

Skills & Qualifications:

  • A bachelor’s degree in Quality Engineering, Quality Assurance, Biomedical Engineering or an equivalent degree from an accredited institution is required and 4+ years’ experience in medical device quality engineer related work or equivalent experience in quality system such as ISO 9001; or Master’s degree with 2+ years’ experience
  • Demonstrated understanding of medical device design and process controls per FDA Quality System Requirements (QSRs) and ISO 13485
  • Demonstrated understanding of required standards / regulations impacting medical devices
  • Team-oriented professional with good interpersonal skills who is hands-on with a high energy approach to work
  • Ability to communicate ideas and information clearly, effectively, and frequently (verbal and written)
  • Ability to prioritize and execute tasks in a timely manner without direct supervision
  • ASQ CQE certification is a plus

To inquire about these opportunities, please contact us at jobs@stellartec.com

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