Senior Quality Engineer (Contract)

Aptyx•Tempe, AZ

19h•Onsite

About The Position

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.

Requirements

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.
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.

Nice To Haves

ASQ Certification (CQE, CQA, or CQM) preferred.
Experience with SPC, MSA, and statistical tools (Minitab preferred).

Responsibilities

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.
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.