Relievant’s Quality Engineer will be helping to advance the company’s minimally invasive low back pain technology. This position is responsible for quality assurance department deliverables and addressing supplier quality issues in alignment with the company’s strategic goals, objectives, resources and priorities.
Essential Responsibilities / Functions:
- Initiate, process and assist in the investigation and closing of Complaints.
- Take responsibility for assigned Corrective and Preventive Actions (CAPAs) performing investigations, creating Corrective Action Plans and Verification Plans, Implementing Corrective Action Plans, and Verifying Effectiveness of the Actions.
- Work with Suppliers to add and/or maintain them on the Approved Supplier List.
- Work with Suppliers to initiate, process and close Supplier Corrective Actions (SCARs).
- Function as a contributing member of multidisciplinary project teams in the design, development, and manufacturing of energy based and non-energy based spinal products.
- Develop and assist others in the development of Quality System documents such as protocols, procedures, work instructions, and equipment specifications.
- Own the responsibility for Equipment Calibration and Maintenance compliance.
- Develop and complete Quality System records as required for the return of product (RGAs), inspection of product (QTMs), and accurate maintenance of required Logs.
- Train to and execute Quality System processes in alignment with the Quality System and all applicable regulatory and quality standards.
- Assist other members of QA and RA with the Engineering Change Order system as needed.
- Able to travel to vendors, labs, and customers as-needed.
- 2+ years of experience in quality engineering.
- 2+ years of experience in the medical device industry.
- Experience with quality management systems in FDA, ISO 13485, and MDD/MDR regulatory environment.
- Demonstrated understanding of an engineering discipline.
- Demonstrated experience in producing effective and timely quality assurance deliverables.
- Versatility, flexibility, and a willingness to work within constantly changing priorities in an early commercialization stage company with enthusiasm.
- Solid understanding of quality engineering principles and quality assurance systems.
- Proficient with using personal computers (Mac preferred) and common spreadsheet, word processing, and email applications.
- Quality Engineering certification(s) a plus.
- BS or MS in Engineering.
We are proud to offer our employees an excellent compensation and benefits package and we are an equal opportunity employer.
For more information or to apply, please contact firstname.lastname@example.org.