What are the responsibilities and job description for the Senior Quality Engineer (Contract) position at Aptyx?
Location: Tempe, AZ Department: Quality Reports To: Site Leadership / Operations Director Position Type: Full-Time | Contract (Temporary – Through October 2026- Exempt)
Position Summary
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.
Key Responsibilities
Quality Leadership & Department Oversight
This is a temporary contract position expected to run through October , 2026- with potential for extension based on business needs.
Position Summary
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.
Key Responsibilities
Quality Leadership & Department Oversight
- 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.