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About the job

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!