Quality Engineer - Medical Devices QMS & CAPA Lead

Barry-Wehmiller; Tucson (AZ); On-site; USD 75,000 - 110,000; Full time

Job summary

Machine Solutions, Inc. in Tucson, AZ seeks a Quality Engineer to support product, process, and quality system performance in a regulated medical device environment.

You will own QMS processes, calibration, CAPA, and supplier quality while partnering with Production, Engineering, Supply Chain, and Quality to prevent issues and improve yields. You will lead document control, audits, and supplier quality activities, applying structured problem solving and risk management to ensure compliance with

Qualifications

• Bachelor’s degree in Engineering, Quality, Manufacturing, or a related technical field (or equivalent experience).
• 3+ years of quality engineering experience in a regulated or highly controlled manufacturing environment.
• Experience within a formal QMS, including document/change control and calibration/measurement equipment control.
• Demonstrated root cause analysis and CAPA experience, and familiarity with nonconformance and risk management processes.

Responsibilities

• Own and administer the site document change control process (ISO 9001 Clause 7.5), including revision control, approval routing, distribution, and obsolescence.
• Maintain the master document list and engineering change orders (ECOs/ECNs), ensuring only current-revision documents are available at points of use.
• Coordinate cross-functional review and approval of document changes with Quality, Engineering, Production, and Supply Chain.
• Control external-origin documents (customer specs, regulatory standards, calibration certificates) and enforce record retention requirements.
• Own and administer the site calibration program for inspection, measuring, and test equipment, ensuring equipment is calibrated within required intervals.
• Coordinate internal/external calibration activities, investigate out-of-tolerance conditions, and assess potential product impact.
• Perform or support measurement system analysis (MSA/Gauge R&R) and qualification of new inspection equipment.
• Provide day-to-day quality engineering support to manufacturing, troubleshooting product and process issues alongside Production and Engineering.
• Lead or support NCR, CAPA, and RCA investigations using structured tools (5-Why, Fishbone, 8D, fault-tree) and verify corrective action effectiveness.
• Analyze defects, nonconformances, scrap, and rework data to identify trends and drive improvements in first-pass yield.
• Monitor warranty trends and field return data to identify recurring failure modes and drive corrective actions back into manufacturing and design.
• Support supplier qualification, performance monitoring, and approval of new or alternate suppliers and component changes.
• Lead or support supplier corrective action requests (SCARs), including root cause review and effectiveness verification.
• Analyze incoming inspection and supplier quality data to identify risks and establish risk-based supplier controls.
• Participate as an internal auditor; support planning, execution, and follow-up of internal audits and audit readiness.
• Support customer, registrar, and regulatory audits, including ISO 9001/ISO 13485 certification audits.
• Coordinate and complete supplier and customer quality questionnaires and compliance documentation.
• Support investigation of customer complaints and field quality issues, feeding lessons learned back into manufacturing.

Education

Bachelor’s degree in Engineering, Quality, Manufacturing, or a related technical field (or equivalent experience)

3+ years of quality engineering experience in a regulated or highly controlled manufacturing environment

Tools

MasterControl

ETQ

M1

Infor LN

Minitab

Job description

Machine Solutions, Inc. in Tucson, AZ seeks a Quality Engineer to support product, process, and quality system performance in a regulated medical device environment.

You will own QMS processes, calibration, CAPA, and supplier quality while partnering with Production, Engineering, Supply Chain, and Quality to prevent issues and improve yields. You will lead document control, audits, and supplier quality activities, applying structured problem solving and risk management to ensure compliance with