Candidates with medical device manufacturing experience and a hands-on quality mindset will find this role suits a practical, execution-oriented Quality Engineer with a focus on compliance and production floor problem-solving.
Derived from job-description analysis by Serendipath's career intelligence engine.
Original posting from Blackcanyonconsulting via Greenhouse
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
Benefits and Salary
We attract the best people in the business with our competitive benefits package that includes medical, dental and vision coverage, 401k plan with employer contribution, paid holidays, vacation, and tuition reimbursement.
If you enjoy being a part of a high performing, professional service and technology focused organization, please apply today!