Senior Quality Engineer – Medical Device Quality Lead

Biomerics LLC; Salt Lake City (UT); On-site; USD 85,000 - 100,000; Full time

Job summary

Biomerics LLC in Salt Lake City, UT is seeking a Senior Quality Engineer to lead quality engineering within extrusion, metals, and plastics teams, developing and maintaining methodologies to meet regulatory and customer requirements.

You will drive control plans, validation activities (IQ/OQ/PQ), risk management, CAPA, supplier quality, and audits, while mentoring other team members and promoting a culture of continuous improvement.

Qualifications

• 5-7 years of experience in Quality Engineering within a medical device manufacturing environment.
• Working knowledge of process development and validation.
• Strong knowledge of Quality Systems and regulations (FDA QSRs, ISO 13485, ISO 14971).
• Experience with root cause analysis, CAPA, and risk management.
• Familiarity with statistical tools and methods.
• ASQ certifications (e.g., CQE, CQA) are preferred.

Responsibilities

• Participate in Product Development teams, providing Quality input and support.
• Develop and implement Control Plans, Master Validation Plans, and Inspection Procedures.
• Develop validation strategies, ensuring all applicable requirements are met from planning, protocol definition, leading execution of protocols, analyzing and reporting results, and completing report and gaining necessary approvals to close.
• Leading the development and results analysis of validation plans (IQ/OQ/PQ), Test Method Validation (TMV), Gage R&R, and test protocols to qualify and validate existing product designs, processes, and equipment.
• Determine and recommend sampling plans, equipment requirements, measurement techniques, and training requirements that will ensure specific quality levels.
• Support new product introductions and design changes.
• Support Manufacturing Engineering in the creation, release, and maintenance of DHR, Bill of Materials, and manufacturing specifications.
• Review and approve product documentation.
• Leads preparation of risk management files and reports for product releases, and has primary responsibility for risk management activities from product conception through commercialization.
• Ensure risk management processes are followed and documented.
• Ensure compliance to Biomerics quality standards, policies, and procedures.
• Support external customer and regulatory agency audits.
• Maintain consistent dialogue with customers and teammates to ensure clear communication and expectations.
• Lead investigations for nonconformances and customer complaints.
• Utilize problem solving tools to analyze and identify root causes and implement corrective actions.
• Identify opportunities for process improvement and implement solutions.
• Monitor quality performance metrics and trends.
• Provide leadership and mentoring to other Quality team members.
• Promote a culture of quality and foster a culture of compliance and continuous improvement.

Skills

Problem solving

Analytical skills

Communication

Teamwork

Education

Bachelor's degree

Tools

Microsoft Office

Minitab

Job description

Biomerics LLC in Salt Lake City, UT is seeking a Senior Quality Engineer to lead quality engineering within extrusion, metals, and plastics teams, developing and maintaining methodologies to meet regulatory and customer requirements.

You will drive control plans, validation activities (IQ/OQ/PQ), risk management, CAPA, supplier quality, and audits, while mentoring other team members and promoting a culture of continuous improvement.