Sr. Quality Engineer
Stellartech is looking for a Senior Quality Engineer to join our QA Team.
- 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 firstname.lastname@example.org