Senior Quality Engineer - Tempe - Aequor

    Aequor
    Aequor Tempe

    23 hours ago

    Upper Management / Consulting
    Description

    Senior Quality Engineer

    Onsite in Tempe, Arizona

    Contract Role until Oct 2026 with Possible Extension

    Our client is seeking a Senior Quality Engineer (Contract) to lead the Quality function at their 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.

    Regulatory & QMS Compliance

    • 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.

    Manufacturing, Process & Facility Transfer Quality

    • 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.

    Supplier & External Quality Support

    • 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.

    Qualifications

    • 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.

    Skills & Competencies

    • 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.

    Regulatory Requirements

    • 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.

    Physical & Work Environment

    • 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.

    Contract Duration

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


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