Senior Quality Engineer

Location: Tempe, AZ Department: Quality Reports To: Site Leadership / Operations Director Position Type: Full-Time | Contract (Temporary – Through October 2026
- Exempt)

Aptyx is seeking a Senior Quality Engineer (Contract) to lead the Quality function at our Tempe site during a transitional period. This individual will serve as the senior on-site quality authority, overseeing quality operations, ensuring regulatory compliance, supporting production and transfer activities, and guiding the quality team to maintain operational excellence.

This is a high-impact leadership role responsible for stabilizing and strengthening the Quality Management System (QMS), supporting production output, managing facility transfer activities, and ensuring compliance with FDA and ISO requirements within a medical device manufacturing environment.

• Serve as the on-site Quality lead and Management Representative, providing daily direction to Quality Inspectors, QE's and Technicians.
• Oversee production quality activities including in-process inspection, final release, and lot history record review.
• Lead Material Review Board (MRB) activities and disposition of nonconforming product.
• Ensure timely release of product to meet customer delivery commitments.
• Provide coaching, training, and performance oversight of quality staff during the contract period.

• Ensure compliance with ISO 13485, and FDA 21 CFR Part 820 requirements.
• Maintain site readiness for internal, customer, and regulatory audits.
• Lead and/or support internal audits and corrective action initiatives.
• Drive CAPA and Complaint investigations, root cause analysis, and implementation of effective corrective actions.
• Support risk management activities including PFMEA updates and control plan alignment.

• Lead and support quality oversight of product and process transfers from one building/facility to another, ensuring regulatory compliance and process integrity.
• Partner with Operations, Engineering, and Validation teams to support equipment moves, process re-qualification, and documentation updates.
• Ensure proper execution of IQ/OQ/PQ or revalidation activities associated with facility transfers.
• Update risk assessments, control plans, inspection methods, and quality documentation as required due to transfer activities.
• Provide hands-on quality engineering support across production and new product transfer activities.
• Review and optimize inspection methods, sampling plans, and quality documentation.
• Monitor and analyze quality metrics; provide trend reporting to site leadership.
• Ensure process controls, SPC, and data analysis are effectively implemented and sustained.

• Oversee supplier quality performance, including corrective action management and material disposition.
• Support PPAP reviews and supplier qualification activities as needed.
• Evaluate customer complaints and returned product investigations.

• Bachelor's Degree in Engineering, Life Sciences, or related technical discipline or equivalent work experience (10 years).
• 5+ years of experience in medical device manufacturing quality.
• 3+ years in a senior or lead quality role.
• Direct experience supporting facility transfers, line moves, or manufacturing site transitions strongly preferred.
• Strong working knowledge of ISO 13485, FDA 21 CFR Part 820, and risk management principles.
• Demonstrated experience leading CAPA, root cause investigations, and audit readiness initiatives.
• Experience supporting production environments with urgency and operational accountability.
• ASQ Certification (CQE, CQA, or CQM) preferred.

• Strong leadership presence with ability to guide teams during transition.
• Advanced problem-solving and analytical skills.
• Experience with SPC, MSA, and statistical tools (Minitab preferred).
• High sense of urgency and accountability.
• Excellent written and verbal communication skills.
• Ability to balance strategic quality oversight with hands‑on floor engagement.
• Strong cross-functional collaboration skills during operational transitions.

• Maintain compliance with FDA, ISO 13485, and applicable regulatory standards.
• Ensure adherence to company Quality Management System procedures.
• Support continued certification and site registration requirements.

• Combination of office and cleanroom/manufacturing floor environment.
• Regular standing, walking production floor, and reviewing documentation.
• Occasional lifting up to 25 lbs.
• Use of inspection equipment and computer systems.

This is a temporary contract position expected to run through October , 2026- with potential for extension based on business needs.