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Quality Engineer

Oxenham Group LLC

Egan, MN

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JOB DETAILS
SKILLS
Accreditation Standards, Analysis Skills, Change Control, Code of Federal Regulations, Continuous Improvement, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Customer Support/Service, Document Control, FDA (Food and Drug Administration), Health Canada, ISO (International Organization for Standardization), Leadership, Maintain Compliance, Manufacturing, Medical Equipment, Promotional Products, Quality Engineering, Quality Management, Regulations, Regulatory Submissions, Research & Development (R&D), Risk Management, Surveillance, Team Player
LOCATION
Egan, MN
POSTED
30+ days ago
The Quality and Regulatory Specialist supports our client by providing end to end regulatory and quality leadership across a diverse medical device portfolio. The role ensures full compliance with FDA, EU MDR, Health Canada, and additional international regulatory frameworks while driving the maintenance and continuous improvement of a globally compliant Quality Management System. This position manages the preparation, submission, and lifecycle maintenance of regulatory filings and serves as a primary interface with regulatory authorities, notified bodies, and certification agencies.
The Specialist plays a central role in sustaining ISO 13485 and 21 CFR Part 820 compliance through document control discipline, audit support, nonconformance management, training, and change control oversight. The position partners closely with R and D, operations, clinical, and manufacturing teams to guide design control execution, risk management rigor, post market surveillance requirements, and the compliant review of labeling, promotional materials, and product changes. The role also supports complaint handling, vigilance reporting, and CAPA activities that protect product quality and regulatory standing.
Success in this position requires two to four years of medical device regulatory or quality experience, strong technical comprehension of ISO and FDA standards, and demonstrated capability navigating regulatory submissions in a fast paced environment. The ideal candidate brings analytical precision, cross functional collaboration skills, and the ability to translate evolving regulatory expectations into clear internal requirements. This is a growth oriented position for a professional who wants to expand regulatory depth while contributing directly to product quality, market access, and operational excellence.

About the Company

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Oxenham Group LLC

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