Production Quality Engineer

Overview

The Production Quality Engineer is responsible for establishing, maintaining, and improving the quality systems and production quality processes required for compliant medical device manufacturing.

This role is quality-focused first, with primary responsibility for ensuring compliance with ISO 13485 and FDA QMSR requirements, while also supporting hands-on problem solving within production operations.

The ideal candidate is a practical, execution-oriented Quality Engineer who is comfortable working directly on the production floor, investigating issues, and driving them to resolution. While the role interfaces with manufacturing, engineering, and supply chain, the core expectation is strong ownership of quality engineering responsibilities.

Job Description

Quality Systems & Regulatory Compliance (Primary Responsibility)

• Develop, implement, and maintain quality system processes aligned with:
• ISO 13485:2016
• FDA QMSR / 21 CFR Part 820
• Author and maintain quality documentation, including:
• SOPs
• Work instructions
• Forms and records
• Support and maintain compliance of a predominantly electronic (paperless) QMS
• Ensure adherence to good documentation practices (GDP) and 21 CFR Part 11 (as applicable)
• Support annual FDA establishment registration and device listing activities; assist with preparation, maintenance, and coordination of regulatory submissions, including 510(k) support, technical file/design dossier support, and submission documentation coordination with Regulatory Affairs, as applicable
• Support internal audits and external audits (FDA, ISO certification, MDSAP readiness)

Nonconformance, CAPA & Issue Resolution

• Investigate nonconforming product and process deviations
• Lead and support CAPA activities, including:
• Root cause analysis (RCA)
• Corrective and preventive actions
• Effectiveness verification
• Support complaint investigations and ensure feedback into manufacturing and process control
• Drive timely and complete resolution of quality events

Production Quality & Hands-On Problem Solving

• Work directly with production and technicians to:
• Investigate product and process issues
• Identify sources of variation and failure modes
• Implement corrective actions
• Ensure production processes meet defined quality requirements
• Support real-time decision-making on product disposition and quality concerns
• Identify and escalate risks to product quality or regulatory compliance
• This role requires a “get your hands dirty” mindset, including active engagement in troubleshooting and issue resolution on the production floor.

Process Validation & Control

• Develop, execute, and maintain:
• IQ/OQ/PQ validation activities
• Support process changes and assess validation impact
• Ensure processes remain in a validated state
• Support development and maintenance of control plans and process monitoring methods

Risk Management

• Support risk management activities aligned with ISO 14971
• Participate in:
• Process FMEA (PFMEA)
• Risk assessment for manufacturing and process changes
• Ensure risk-based decision making in quality and production activities

Supplier Quality (Supporting Role)

• Support incoming inspection processes and acceptance criteria
• Assist in supplier issue investigations and corrective actions
• Collaborate with supply chain and engineering to ensure material quality

Cross-Functional Collaboration

• Partner with:
• Manufacturing
• Engineering
• Supply Chain
• Regulatory / Quality teams
• Provide quality input on:
• Design changes
• Manufacturing processes
• Product performance issues
• Support design transfer and production readiness as needed

Supplier Quality & Material Control

• Support supplier selection, qualification, and evaluation
• Oversee incoming inspection and acceptance criteria
• Participate in supplier audits and drive supplier corrective actions as needed
• Ensure material quality supports consistent production outcomes

Training & Workforce Development

• Train and support technicians performing assembly, testing, and inspection
• Develop training materials and ensure competency and training effectiveness
• Promote best practices in documentation, quality, and process adherence