Relievant’s Quality Engineer II will be helping to advance the innovative and practical solutions associated with the diagnosis and treatment of vertebrogenic pain. This position is responsible for quality assurance department deliverables and addressing quality issues in alignment with the company’s strategic goals, objectives, resources, and priorities. This individual will support a growing environment focused on mitigating quality risks that may impact Relievant Medsystems, Inc. and its customers.
- Our corporate office is in Edina, MN. We provide a hybrid work model that includes days working from our corporate office and remotely.
- Initiate, process, and assist in the investigation and closure of Complaints in a timely manner.
- Perform hands on failure analysis on product received from the field to determine root cause.
- Communicate failure analysis results to a cross functional team to drive root cause determination and trending analyses.
- Writes and reviews complaint investigation reports and provide technical input towards material, product, manufacturing, and design improvements.
- Take responsibility for assigned Corrective and Preventive Actions (CAPAs) performing investigations, creating Corrective Action and Verification Plans, Implementing Corrective Action Plans, and Verifying Effectiveness of the actions.
- Develop and complete Quality System records as required for the return of product (RMAs), inspection of product (QTMs), and accurate maintenance of required Logs.
- Support supplier quality audits, internal audits, and external audits as needed.
- Function as a technical member of multidisciplinary project teams in the design, development, and manufacturing of energy based and non-energy based spinal products.
- Work with Suppliers to add and/or maintain them on the Approved Supplier List.
- Develop and assist others in the development of Quality System documents such as protocols, procedures, work instructions, and equipment specifications.
- Respond to changes in regulations by updating protocols, procedures and work instructions to maintain compliance.
- Train to and execute Quality System processes in alignment with the Quality System and all applicable regulatory and quality standards.
- Able to travel to vendors and labs as needed.
Education and Experience:
- BS or MS in Engineering.
- 2+ years of experience in quality engineering.
- 2+ years of experience in the medical device industry preferred.
- Experience with quality management systems in FDA, ISO 13485, and MDD/MDR regulatory environment strongly preferred.
- QMS preferred.
- Demonstrated understanding of an engineering discipline.
- Problem solving skills are required.
- Knowledge or some education in producing effective and timely quality assurance deliverables.
- Versatility, flexibility, and a willingness to work within constantly changing priorities in a rapidly growing 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.
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 add the name of the position in the subject line along with your resume to: firstname.lastname@example.org.