Quality Engineer

Quality Engineer Job Description

The Operations Quality Engineer plays a pivotal role in supporting and maintaining quality compliance within US Operations. This position is responsible for recommending and implementing process improvements to ensure regulatory compliance, with a strong focus on patient safety and product quality. Responsibilities include: providing quality engineering support to US Operations to ensure compliance with FDA regulations, acting as the first line support for quality issues and recommending quality improvements, conducting and documenting root cause investigations of non-conforming processes and products, facilitating material review board meetings, participating in or leading corrective and preventive actions as appropriate, reviewing sampling techniques, methods, rationale, and test methods to ensure appropriateness, reviewing quality content in change control for products and processes, reviewing and authoring validation documents and validating processes, initiating change requests to update documentation and processes, performing data analysis, writing summary reports, and other technical memoranda, coordinating and supporting calibration activities, ensuring equipment is appropriately calibrated, addressing out-of-calibration issues, maintaining applicable quality management system instructions, supporting and participating in internal and external audits, conforming with the code of conduct and all local compliance standards, conforming with the quality/ehs policy, and performing other duties as assigned.

Essential Skills include a Bachelor’s degree in a relevant science or engineering discipline, experience in process validation, change control systems, and sample size determination, familiarity with FMEA and various statistical techniques, proficiency in analytical problem-solving, excellent data analysis skills using statistical tools such as Minitab, effective verbal and written communication skills, ability to manage multiple projects and priorities, and strong computer skills, including proficiency in Microsoft Office (Word, Excel, PowerPoint).

Additional Skills & Qualifications include knowledge of FDA regulations (21 CFR Part 820) and related standards, ability to apply standard techniques and procedures to perform assigned tasks, judgment on details of work and developing skills in the operations quality function, minimum of five years of related experience in medical device manufacturing, experience with continuous improvement, Lean Six Sigma, or similar programs, familiarity with geometric dimensioning and tolerancing, and experience performing internal audits.

Pay and Benefits: The pay range for this position is $45.00 - $70.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: medical, dental & vision, critical illness, accident, and hospital, 401(k) retirement plan – pre-tax and Roth post-tax contributions available, life insurance (voluntary life & AD&D for the employee and dependents), short and long-term disability, health spending account (HSA), transportation benefits, employee assistance program, time off/leave (PTO, vacation or sick leave).

Workplace Type: This is a fully onsite position in Minneapolis, MN. Application Deadline: This position is anticipated to close on Sep 23, 2025.

About Actalent: Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation, and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.