Quality Engineer

Job Title: Quality Engineer

Location: Taunton, MA

Department: Quality

Reports to: Quality Manager

Position Summary

Aptyx is seeking a Quality Engineer to join the Quality Department at our Taunton, MA Location. This individual will assist in maintaining quality operations, ensuring regulatory compliance, supporting production and transfer activities, and helping the quality team maintain operational excellence.

This is a high-impact 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 13485 requirements within a medical device manufacturing environment.

Key Responsibilities

Quality Engineering

• Assist production quality activities including in-process inspection, final release, and lot history record review.
• Lead Material Review Board (MRB) activities and disposition of nonconforming products.
• Ensure timely release of product to meet customer delivery commitments.
• Interface with customers and suppliers, as required, to resolve quality issues
• Ensure Risks are identified and documented
• Monitor 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.

Regulatory & QMS Compliance

• Assist in ensuring compliance with ISO 13485, and FDA 21 CFR Part 820 requirements.
• Assist in maintaining 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.
• Supports Change Control, works with the Cross-Functional Team for Impact Assessment, and ensures the timely completion of activities while updating relevant documents.

. 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.

Qualifications

• Bachelor's degree in engineering, Life Sciences, or related technical discipline or equivalent work experience (7+ years).
• 5+ years of experience in medical device manufacturing quality.
• 5+ years in a 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 ISO 14971 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

• 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 handheld inspection equipment, vision systems, laser mikes and computer systems.