Senior Quality Engineer - Medical Devices (Onsite, Utah)

Grove Technical Resources; Utah; On-site; USD 90,000 - 120,000; Part time

Job summary

Grove Technical Resources seeks a Senior Quality Engineer/Quality Engineering Consultant to provide hands-on quality leadership in a medical device manufacturing environment. You will own complex investigations, drive containment strategies, and partner with Manufacturing Engineering to stabilize high-risk processes.

The role requires senior experience in quality systems, CAPA, SCARs, and process validation, with a focus on molding, extrusion, welding, and packaging.

Qualifications

• Bachelor's degree in engineering, Quality, or a related technical discipline.
• Strong experience as a Quality Engineer in a regulated medical device manufacturing environment.
• Senior-level experience leading quality investigations and resolving complex manufacturing issues.
• Strong knowledge of root cause analysis, nonconformance investigations, SCARs, CAPA, and audit remediation.
• Experience with process validation and equipment qualification.

Responsibilities

• Provide senior-level quality engineering support and technical guidance to a developing Quality team.
• Assess current quality processes, team capabilities, and areas requiring improvement.
• Lead and support investigations involving nonconformances, SCARs, audit findings, customer complaints, and manufacturing issues.
• Drive investigations beyond operator error to identify systemic root causes and effective corrective actions.
• Develop and implement process controls and containment strategies to stabilize operations.
• Support the resolution and closure of a backlog of quality investigations and documentation.
• Apply structured root cause analysis, CAPA, and continuous improvement methodologies.
• Support manufacturing processes including molding, extrusion, gluing, welding, tipping, over molding, assembly, packaging, and labeling.
• Investigate issues involving exposed wire, cold braid, tipping flash, sealing, labeling, sterilization, line clearance, and other manufacturing defects.
• Partner with Manufacturing Engineering to evaluate equipment-related issues and determine process/quality controls.
• Support process validation, equipment qualification, and validation activities.
• Utilize quality data and statistical methods, including SPC, to monitor and improve processes.
• Work with internal and external suppliers on quality issues, investigations, and SCARs.

Skills

Quality leadership

Root cause analysis

CAPA

Audit remediation

SPC

Cross-functional collaboration

Independent leadership

Investigations management

Education

Bachelor's degree in engineering/Quality/related technical discipline

Job description

Grove Technical Resources seeks a Senior Quality Engineer/Quality Engineering Consultant to provide hands-on quality leadership in a medical device manufacturing environment. You will own complex investigations, drive containment strategies, and partner with Manufacturing Engineering to stabilize high-risk processes.

The role requires senior experience in quality systems, CAPA, SCARs, and process validation, with a focus on molding, extrusion, welding, and packaging.