Senior Design Quality Engineer

• Job Title:Senior Design Quality Engineer
• Company Name:Biomerics
• Location:Salt Lake City, UT
• Position Type:Full Time, Employee
• Competitive Salary & Benefits

Company Overview: Biomerics is a leading and innovative polymer solution provider to the medical device and biotech industries. We manufacture biomaterials, extrusions, injection-molded components, and finished medical devices for many of the world's leading medical device corporations. We partner with our customers to increase their profitability through material technology, operational excellence, and premier market-based customer service.

Position Summary: The Senior Design Quality Engineer supports the Design and Development group to ensure devices, components, and materials in development comply with Biomerics SOP's and applicable regulatory standards.

Job Responsibilities:

• Manage projects and provide project support from the Quality function
• Interact effectively with customers, suppliers, and internal resources
• Risk Management, identify risks and develop mitigation actions
• Lead or support design and process validations (DV, IQ, OQ, PQ)
• Quality System maintenance and improvement
• CAPA ownership and/or support

Desired Skills

• Strong communication, presentation, and project management skills
• Root cause analysis
• Technical writing
• Statistical Analysis (Six Sigma preferred)
• Microsoft Office and Minitab Statistical Analysis software (or equivalent)
• Ability to develop effective, positive interpersonal relationships, and lead a cross-functional team.
• Effectively employ problem-solving tools/methodology
• High sense of urgency and commitment to execution
• Driven, energetic, self-assured professional with high personal integrity

Qualifications

• Bachelor's Degree in Engineering or related science discipline
• Engineering experience with a Medical Device company
• Knowledge of Design Controls (FDA 21 CFR 820.30)
• Experience with design, process, and test method validations (DV, IQ, OQ, PQ, TMV)
• Experience with Risk Management (Risk Management Plans, FMEA's) and associated standards (ISO 14971:2019)
• Familiar with Quality Management Systems (FDA 21 CFR 820 and ISO 13485:2016)
• Experience working in cross-functional teams and driving projects to completion

Biomerics offers the following benefits: Medical/Dental/Vision Insurance, Short-Term Disability, Long-Term Disability, Life Insurance, Paid Vacation Days, 9 Paid Holidays, 401k, Onsite Fitness Facility