Quality Engineer

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

Location: Utah

Work Arrangement: 100% onsite

Employment Type: Contract / Consulting

About this position

We are seeking a Senior Quality Engineer / Quality Engineering Consultant to provide hands-on quality leadership and technical support within a medical device manufacturing environment.

This is an excellent opportunity for a senior-level Quality Engineer who can hit the ground running, take ownership of complex quality investigations, reduce investigation backlogs, strengthen manufacturing controls, and help stabilize a high-risk medical device product line.

Key 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 simple "operator error" conclusions to identify systemic root causes and effective corrective actions.
• Develop and implement appropriate process controls and containment strategies to stabilize manufacturing operations.
• Support the resolution and closure of a significant 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 closely with Manufacturing Engineering to evaluate equipment-related issues and determine appropriate process and quality controls.
• Support process validation, equipment qualification, and validation activities associated with process or equipment changes.
• Utilize quality data and statistical methods, including SPC, to monitor and improve manufacturing processes.
• Work with both internal and external suppliers on quality issues, investigations, and SCARs.

Manufacturing Environment

The facility manufactures high-risk medical devices used in cardiac procedures. Products are vertically integrated and may involve:

• Plastic molding and extrusion
• Tubing and reinforced tube construction
• Tipping
• Welding and bonding
• Over molding
• Sealing
• Packaging and labeling
• Third-party sterilization

Required 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.
• Experience working with manufacturing processes such as molding, extrusion, welding, bonding, gluing, or assembly.
• Strong understanding of medical device quality systems and regulated manufacturing practices.
• Experience using SPC/statistical analysis to evaluate and control manufacturing processes.
• Ability to work independently and provide technical leadership to a developing team.
• Strong written and verbal communication skills.
• Comfortable interacting directly with customers and serving as the quality representative for a product line.
• Demonstrated ability to quickly assess problems, establish priorities, and drive issues to resolution.

Preferred Qualifications

• Previous leadership, mentoring, or manager-level Quality Engineering experience.
• Experience in a contract manufacturing environment.
• Experience supporting high-risk or Class II/III medical devices.
• Supplier quality and SCAR experience.
• Experience with manufacturing process improvement and error-proofing.
• Lean/Six Sigma or similar continuous improvement experience.