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).

Education and Experience

• 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.

Required Qualifications

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.

Preferred Qualifications

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.

We offer…

• Growth & Development: Ongoing continuing education, hands-on training, and opportunities to expand your skills.
• Career Advancement Support: Assistance in earning professional certifications and pursuing further education.
• Retirement Benefits: 401(k) plan with employer matching.
• Comprehensive Health Coverage: Medical, dental, vision, and life insurance options.
• Wellness Focus: Access to programs designed to support your overall well-being.
• Work–Life Balance: Paid time off and flexible work environment
• Flexibility & Trust: A flexible schedule and work environment built around mutual trust and accountability.
• Share the Talent, Share the Rewards: We value great people recommending great people, which is why our employee referral program is designed to reward you continuously

We offer a competitive salary and great benefits. At Excel Engineering, we’re proud of our positive, high-performing culture where teamwork, continuous improvement, and a service-oriented mindset help us do our best work every day. If you enjoy a fast-paced and rewarding environment, you’ll love being part of our team!

Excel Engineering, Inc. is proud to be an Equal Opportunity Employer. We welcome and consider all qualified applicants without regard to race, color, religion, national origin, sex, sexual orientation, gender identity, disability, age, veteran status, marital status, or any other protected characteristic.

We value diverse perspectives and believe they strengthen our work, our teams, and the solutions we deliver to clients. We encourage candidates from backgrounds traditionally underrepresented in engineering to apply. If you need accommodations during the application or interview process, please contact our Human Resources team at ExcelHR@exceleng.net.