Quality Assurance Engineer

Job Title: Quality Assurance Engineer **M-F and 2/2/3 schedule 6pm 6:10am**Job DescriptionThe Quality Assurance Engineer plays a key role in ensuring the safe, compliant, and efficient production of infant formula within a highly regulated, GMP-controlled manufacturing environment. This role responds to and investigates quality deviations, leads root cause analysis, supports production teams on the manufacturing floor, and produces detailed technical deviation reports to enable timely and compliant product release. The position requires strong scientific writing skills, the ability to juggle multiple investigations simultaneously, and a coaching mindset to build relationships and improve quality practices across the operation.Responsibilities

• Respond to quality management system (QMS) deviations that occur during the production process and manage them through to resolution.
• Conduct thorough root cause analyses using tools such as 5 Whys Analysis, Gemba Walks, Fishbone (Cause-and-Effect) Diagrams, and other standard problem-solving methodologies.
• Ensure that product is not released when a deviation has occurred until investigations and corrective actions are completed and documented in accordance with procedures.
• Investigate consumer complaints related to product quality and document findings and outcomes in a clear and comprehensive manner.
• Serve as one of the primary quality representatives on the manufacturing floor, maintaining strong relationships with production crews and leadership to coach and guide team members on quality expectations.
• Provide support to production operations, working closely with 3050 production team members as well as production supervisors, maintenance supervisors, and other leaders to address quality issues and prevent recurrence.
• Spend significant time on the manufacturing floor to support deviations, observe processes, and verify that production staff follow standard operating procedures (SOPs) and good manufacturing practices (GMPs).
• Participate in daily shift huddles to review priority deviations, align on investigation plans, and determine additional support needed, such as swabbing, non-routine interventions, and other quality-related activities.
• Perform GMP walks and floor audits to identify potential deviations and opportunities for improvement, and communicate findings constructively to production teams.
• Support the batch release team by reviewing batch documentation, identifying and correcting paperwork errors, and ensuring records meet compliance requirements.
• Write detailed deviation reports as a primary desk responsibility, including incident descriptions, root cause analysis, corrective and preventive actions, and timelines for completion.
• Use TrackWise or similar deviation management software to document incidents, manage workflows, and ensure all required reviews and approvals are completed within established timelines.
• Update and revise SOPs in systems such as OpenText to reflect process changes, investigation outcomes, and continuous improvement initiatives.
• Manage multiple deviations simultaneously, including those with differing complexity and timelines, and ensure completion within required timeframes (e.g., multiple deviations closed within 30 days).
• Collaborate with supervisors and cross-functional teams to review deviation descriptions and investigation findings before finalizing documentation and moving investigations forward.
• Act as a coach and partner on the manufacturing floor, helping production staff understand quality requirements and viewing quality as a support function rather than a policing role.
• Audit manufacturing activities and documentation to detect potential or actual deviations, and initiate investigations as needed to protect product quality and compliance.
• Contribute to continuous improvement efforts by identifying recurring issues, proposing process improvements, and supporting implementation of preventive measures.
• Communicate clearly and professionally with all departments, explaining what happened, why it happened, and how processes can be improved, while actively seeking information and asking questions to fully understand operations.

Essential Skills

• Bachelors degree in Life Sciences or a related scientific discipline.
• 12+ years of food manufacturing experience in a GMP-regulated environment.
• 12+ years of GMP experience, preferably in food, pharmaceutical, biotechnology, or medical device industries.
• At least 1 year of quality experience with a solid understanding of compliance requirements in complex food manufacturing operations.
• Strong scientific and technical writing skills, including the ability to produce in-depth deviation reports that may extend to 15 pages or more.
• Demonstrated ability to lead or participate in deviation investigations, identify root causes, and outline corrective and preventive measures.
• Proficiency in conducting root cause analysis using tools such as 5 Whys Analysis, Gemba Walks, and Fishbone (Cause-and-Effect) Diagrams.
• Experience working in a food manufacturing environment under GMP, with a clear understanding of SOPs and quality standards.
• Strong verbal and written communication skills, with the ability to collaborate effectively across multiple departments and levels within the organization.
• Ability to organize and manage multiple tasks and changing priorities to meet investigation and project deadlines.
• Comfort working in a fast-paced, high-scrutiny environment (e.g., infant formula regulated by the FDA) with multiple concurrent deviations and investigations.
• Self-motivated, proactive, and willing to ask questions to fully understand processes and uncover root causes.
• Ability to build strong working relationships and adopt a coaching mindset to support and guide production teams on quality practices.
• Comfort being on your feet for most of the shift and working in both standard manufacturing and hot environments such as dryer rooms.

Additional Skills & Qualifications

• Demonstrated understanding and application of continuous improvement methodologies and root cause analysis beyond basic tools.
• Experience working with SAP systems in a manufacturing or quality context.
• Any experience with PCQI (Preventive Controls Qualified Individual) in human food is beneficial.
• Experience using TrackWise or similar deviation management software to document and manage investigations.
• Experience updating and maintaining SOPs and other controlled documents in systems such as OpenText.
• Background in pharmaceutical industry, biotechnology, or medical device manufacturing in addition to food manufacturing is a plus.
• Prior experience leading deviation investigations from start to finish, including root cause determination and preventive action planning, is highly desirable.
• Demonstrated ability to thrive on night shifts or in environments with less on-site leadership, using autonomy as an opportunity to build skills and ownership.
• Proven track record of building trust with production teams and shifting perceptions of quality from enforcement to partnership and coaching.
• Interest in developing a long-term career in quality, with openness to progressing into specialized or leadership roles over time.

Work EnvironmentThis role operates in a blended environment, with approximately 50% of time spent on the manufacturing floor and 50% in an office setting. On the floor, the Quality Assurance Engineer works closely with production crews, supervisors, maintenance, and other leaders, often standing and walking for extended periods and spending time in areas such as dryer rooms where conditions can be hot. The environment is highly regulated, focused on infant formula production under strict FDA and GMP oversight, requiring consistent adherence to SOPs, GMPs, and detailed documentation practices. Office-based work centers on writing deviations, updating SOPs in systems like OpenText, and managing investigations in TrackWise or similar software. The schedule follows a 2/2/3 pattern, meaning you work roughly half of the days in a year and enjoy a three-day weekend every other week, with opportunities to use a small amount of PTO to create extended periods off. Night shift work offers significant exposure and responsibility due to fewer leaders on site, providing strong skill-building opportunities and autonomy. The quality team includes multiple roles such as validation, quality control, internal auditing, SAP quality, change control, food safety, batch release, quality hygienists, associate quality engineers, QA technicians, QC technicians, methods coordinators, and R&D professionals, creating a collaborative and supportive culture. Team members support one another, and there is a strong emphasis on development and internal promotion, with many individuals progressing from quality engineering and night shift roles into advanced or supervisory positions. Benefits during contract periods can include accrued paid time off and paid holidays, contributing to a balanced and sustainable work experience. Job Type & LocationThis is a Contract to Hire position based out of Eau Claire, WI. Pay and BenefitsThe pay range for this position is $25.00 - $35.58/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.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) Job Type & LocationThis is a Contract to Hire position based out of Eau Claire, WI. Application DeadlineThis position is anticipated to close on Nov 10, 2026. Workplace TypeThis is a fully onsite position in Eau Claire,WI.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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

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