Quality Engineer (MN)

Excel Engineering, Inc.•Mounds View, MN

61d•$80,000 - $120,000•Onsite

About The Position

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.

Requirements

Bachelor’s degree in Engineering, Life Sciences, or a related technical field.
3+ years of quality engineering experience in pharmaceutical and/or medical device manufacturing.
Strong working knowledge of: FDA and international GMP regulations, ISO 13485 and/or FDA QMSR, CAPA, deviations, change control, and risk management
Experience supporting audits and regulatory inspections.
Excellent technical writing and documentation skills.
Ability to write and speak in the English language.
Willingness to travel up to 10% of the time.

Nice To Haves

Consulting or multi-site support experience.
Experience with automation, manufacturing systems, or computerized systems.
Knowledge of CSA, data integrity, and validation best practices.
ASQ certification (CQE, CQA) or equivalent.
Experience supporting both pharma and medical device client.
Engineer in Training (EIT) registration or ability to obtain registration.

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).