Medical Device Quality And Compliance Specialist

Job Description

Job Description

Job Title: Medical Device Quality and Compliance Specialist

Hybrid role! Monday and Friday will work from home and Tuesday, Wednesday and Thursday will be in office.

We are looking for people that can virtual interview this week and start next week or the week after!

• Seeking 1+ year of experience in any of the following areas: complaint handling, MDR reportability assessments, post-market surveillance, CAPA support, audit readiness, risk-based documentation, and cross-functional collaboration across Quality, Regulatory Affairs, Clinical, R&D, Operations, and business stakeholders. Brings practical exposure to FDA medical device reporting expectations, 21 CFR Part 803, complaint-handling requirements, quality-system documentation, eMDR/FDA reporting workflows, regulatory decision rationale, and audit-ready records.

Required

• Strong technical writing, analytical thinking, attention to detail, prioritization, organization, documentation accuracy, project coordination, and ability to manage multiple deadlines in a regulated environment.
• Ability to interpret technical product information and translate it into regulatory decisions or documentation.
• Microsoft Office / Excel / Word / PowerPoint, regulatory databases, tracking tools, complaint systems, SAP, TrackWise, ETQ Reliance, RIMS/Veeva Vault, FDA eSTAR, ESG/eMDR workflows, and GUDID/UDI-related systems where applicable.

Job Type & Location

This is a Contract position based out of Mettawa, IL.

The pay range for this position is $35.00 - $35.00/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 hybrid position in Mettawa,IL.

This position is anticipated to close on Aug 19, 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 [email protected] 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.