"Alerted.org

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

+ Provide quality engineering support to US Operations to ensure compliance with FDA regulations.

+ Act as the first line support for quality issues and recommend quality improvements.

+ Conduct and document root cause investigations of non-conforming processes and products.

+ Facilitate Material Review Board meetings.

+ Participate in or lead Corrective and Preventive Actions as appropriate.

+ Review sampling techniques, methods, rationale, and test methods to ensure appropriateness.

+ Review quality content in change control for products and processes.

+ Review and author validation documents and validate processes.

+ Initiate Change Requests to update documentation and processes.

+ Perform data analysis, write summary reports, and other technical memoranda.

+ Coordinate and support calibration activities, ensuring equipment is appropriately calibrated.

+ Address out-of-calibration issues.

+ Maintain applicable Quality Management System instructions.

+ Support and participate in internal and external audits.

+ Conform with the Code of Conduct and all local Compliance Standards.

+ Conform with the Quality/EHS Policy.

+ Perform other duties as assigned.

Essential Skills

+ 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.

+ Strong computer skills, including proficiency in Microsoft Office (Word, Excel, PowerPoint).

Additional Skills & Qualifications

+ 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.

+ 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 Oct 10, 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 [email protected] (%[email protected]) for other accommodation options.