Quality Engineer (MN)
Quality Engineer (MN)
Full-time
Mounds View, MN
Description
Excel Engineering is seeking a team-oriented, highly motivated Quality Engineer for our Mounds View, Minnesota office.
As a Quality Engineer, you will provide hands-on quality engineering and compliance support to pharmaceutical and medical device manufacturing clients. This role partners with client quality, manufacturing, validation, and regulatory teams to ensure compliance with FDA, EU, and international regulations while driving continuous improvement, risk reduction, and operational excellence across the product lifecycle.
You may support multiple client sites and projects, contributing expertise in quality systems, GMP compliance, risk management, validation, audits, and remediation activities.
Primary Responsibilities
- Support development, implementation, and maintenance of Quality Management Systems (QMS) compliant with:
- FDA 21 CFR Parts 11, 210/211, 820 (QMSR)
- ISO 13485, ISO 9001 (as applicable)
- EU MDR/IVDR and EU GMP requirements
- Author, revise, review, and approve quality documentation, including SOPs, work instructions, and quality records.
- Ensure alignment with data integrity and documentation best practices (ALCOA+).
- Provide quality oversight for pharmaceutical and medical device manufacturing operations.
- Support deviations, nonconformances, investigations, and root cause analyses.
- Lead or support CAPA development, execution, and effectiveness checks.
- Partner with manufacturing, engineering, and automation teams to assess the quality impact of process changes.
- Support risk management activities in accordance with ISO 14971 and ICH guidelines.
- Participate in or lead:
- Process validation and revalidation
- Equipment and system qualification (IQ/OQ/PQ)
- Computer System Validation (CSV) / Computer Software Assurance (CSA)
- Review and approve validation protocols and reports from a quality perspective.
- Support supplier qualification, audits, and quality agreements.
- Review and approve change controls, ensuring regulatory and quality impact assessments are complete.
- Assist with technology transfers and new product introductions (NPI).