Production Quality Engineer

Black Canyon Consulting•Bethesda, MD

6d•Onsite

About The Position

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.

Requirements

Experience in establishing, maintaining, and improving quality systems and production quality processes for medical device manufacturing.
Knowledge of ISO 13485 and FDA QMSR / 21 CFR Part 820 requirements.
Experience authoring and maintaining quality documentation (SOPs, work instructions, forms, records).
Experience supporting electronic QMS.
Understanding of good documentation practices (GDP) and 21 CFR Part 11.
Experience supporting regulatory submissions (e.g., 510(k)).
Experience supporting internal and external audits (FDA, ISO, MDSAP).
Experience investigating nonconforming product and process deviations.
Experience leading and supporting CAPA activities (RCA, corrective/preventive actions, effectiveness verification).
Experience supporting complaint investigations.
Experience working directly with production and technicians to investigate issues and implement corrective actions.
Experience with IQ/OQ/PQ validation activities.
Experience supporting process changes and assessing validation impact.
Experience with control plans and process monitoring methods.
Experience supporting risk management activities aligned with ISO 14971.
Experience with Process FMEA (PFMEA).
Experience supporting incoming inspection processes and acceptance criteria.
Experience assisting in supplier issue investigations and corrective actions.
Experience providing quality input on design changes, manufacturing processes, and product performance issues.
Experience supporting design transfer and production readiness.
Experience supporting supplier selection, qualification, and evaluation.
Experience overseeing incoming inspection and acceptance criteria.
Experience participating in supplier audits and driving supplier corrective actions.
Experience training and supporting technicians.
Experience developing training materials.

Nice To Haves

Practical, execution-oriented mindset.
Comfortable working directly on the production floor.
Hands-on problem-solving skills.
Strong ownership of quality engineering responsibilities.
Ability to drive issues to resolution.
Experience with a predominantly electronic (paperless) QMS.
Experience with MDSAP readiness.
Experience with technical file/design dossier support.
Experience with real-time decision-making on product disposition and quality concerns.
Ability to identify and escalate risks to product quality or regulatory compliance.
Experience with supplier quality and material control.
Experience promoting best practices in documentation, quality, and process adherence.

Responsibilities

Develop, implement, and maintain quality system processes aligned with ISO 13485:2016 and 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).
Investigate nonconforming product and process deviations.
Lead and support CAPA activities, including root cause analysis (RCA), corrective and preventive actions, and effectiveness verification.
Support complaint investigations and ensure feedback into manufacturing and process control.
Drive timely and complete resolution of quality events.
Work directly with production and technicians to investigate product and process issues, identify sources of variation and failure modes, implement corrective actions, and 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.
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.
Support risk management activities aligned with ISO 14971.
Participate in Process FMEA (PFMEA) and risk assessment for manufacturing and process changes.
Ensure risk-based decision making in quality and production activities.
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.
Provide quality input on design changes, manufacturing processes, and product performance issues.
Support design transfer and production readiness as needed.
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.
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.