Quality Assurance Associate

The Quality Assurance Associate supports a robust quality system by managing product complaints, conducting investigations, and ensuring compliance with applicable regulations and internal procedures. This role independently handles customer inquiries, performs detailed complaint evaluations, supports regulatory reporting, and contributes to process improvements that enhance product quality and customer satisfaction.

Responsibilities

• Independently field inquiries received by phone, electronic, or verbal correspondence and determine whether they qualify as complaints in accordance with applicable standard operating procedures.
• Document reported issues accurately and completely, following all relevant SOPs and quality system requirements.
• Provide technical support and remote troubleshooting guidance to users and customers as needed.
• Review associated records independently and contact users and customers to collect detailed information on treatments, product performance, and functionality.
• Conduct periodic follow-up with customers and internal stakeholders to ensure timely closure of complaints.
• Manage customer relationships and expectations throughout the complaint investigation process, maintaining clear and professional communication.
• Independently complete complaint investigations, including coordinating or executing product returns and subsequent evaluations as required.
• Review manufacturing records and other relevant documentation as part of complaint investigations, ensuring proper approvals are obtained prior to closure.
• Develop practical solutions to a variety of moderately complex problems related to product quality and performance.
• Conduct statistical analysis of complaint trends and provide insights that support quality improvement initiatives.
• Support the training program by training users on the complaint process, tools, and methods used to assess and investigate complaints.
• Support and, when appropriate, identify operational changes to improve efficiencies in all aspects of complaint handling.
• Sometimes lead investigations associated with product deviations, product non-conformances, corrective and preventive actions (CAPAs), scrap, and rework, and analyze data to identify root causes and opportunities for quality improvement.
• Update internal operating procedures and specifications through the document change process to reflect process improvements and regulatory requirements.
• Support and participate in internal quality system audits by providing documentation, explanations, and follow-up actions.
• Support external quality system audits by assisting with preparation, participating in audit activities, and implementing corrective actions as needed.
• Evaluate complaints to determine whether submission of a Medical Device Report (MDR) or other Vigilance Report is required based on regulatory criteria.
• Prepare and submit MDRs and Vigilance Reports within required regulatory timelines, ensuring accuracy and completeness of information.

• Experience in quality assurance or other regulated industry or similar experience (preferred).
• Knowledge of quality principles and practices, including inspection activities (inspect*).
• Familiarity with FDA regulations and expectations for regulated products.
• Understanding of Good Manufacturing Practices (GMP).
• Understanding of Good Laboratory Practices (GLP).
• Experience or exposure to medical device (Med* Device) quality or regulatory environments.
• Strong technical writing skills, with the ability to document investigations, complaints, and reports clearly and accurately (required).
• Strong general problem-solving skills and the ability to develop solutions to moderately complex issues (required).
• Ability to manage multiple priorities and work effectively despite interruptions (required).
• Customer service skills, including the ability to manage customer expectations and maintain professional communication.
• Proficiency with Microsoft Excel for tracking, trending, and statistical analysis of complaint data.

• Bachelor of Science (BS) in a Physical Science or Engineering, or equivalent experience (required).
• Experience working within a quality system in a regulated industry, such as medical devices, pharmaceuticals, or related fields (preferred).
• Experience supporting or participating in internal and external quality system audits.
• Experience with complaint handling processes, including documentation, investigation, and closure.
• Familiarity with Medical Device Reporting (MDR) and Vigilance reporting requirements and timelines.
• Ability to adapt to constant and sometimes sudden changes in role, processes, or organizational priorities.
• Strong interpersonal and communication skills for collaborating with cross-functional teams and training users on complaint processes.
• Attention to detail and accuracy in documentation, data analysis, and regulatory reporting.

This is a first-shift position with core hours of 7:00 a.m. to 3:30 p.m., Monday through Friday, with an additional hour of work per day expected. There may be occasions when work of up to four hours on Saturdays is requested; while this is typically voluntary, candidates should be comfortable and capable of working Saturdays as required. The work environment supports a family-oriented culture where team members actively support one another and collaborate to achieve shared goals. The organization regularly undergoes change, so the ideal candidate is comfortable working in a dynamic environment where responsibilities and processes may evolve. The role operates within a regulated quality system environment, using standard office and computer-based tools such as Microsoft Excel, and involves frequent communication by phone and electronic correspondence with customers and internal teams.

Job Type & Location

This is a Contract position based out of Sturtevant, WI.

The pay range for this position is $24.00 - $26.00/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)

This is a fully onsite position in Sturtevant,WI.

This position is anticipated to close on Jul 10, 2026.

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.

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 process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.

Salary : $24 - $26