Medical Device Quality And Compliance Specialist

Job Description

Job Description

Job Title: Medical Device Quality and Compliance Specialist Job Description

We are seeking a Medical Device Quality and Compliance Specialist experienced in complaint handling, MDR reportability assessments, post-market surveillance, CAPA support, audit readiness, and risk-based documentation. The ideal candidate will engage in cross-functional collaboration across Quality, Regulatory Affairs, Clinical, R&D, Operations, and business stakeholders. This role requires 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.

• Handle and assess medical device complaints and MDR reportability.
• Conduct post-market surveillance activities and support CAPA processes.
• Ensure audit readiness and maintain risk-based documentation.
• Collaborate with Quality, Regulatory Affairs, Clinical, R&D, Operations, and business stakeholders.
• Manage quality-system documentation and eMDR/FDA reporting workflows.
• Provide regulatory decision rationale and maintain audit-ready records.

• Strong expertise in medical device quality assurance and regulatory compliance.
• Proficiency in technical writing and corrective action plans.
• Experience with FDA medical device reporting, including 21 CFR Part 803.
• Ability to handle complaint systems and manage documentation.

• Strong technical writing, analytical thinking, and attention to detail.
• Proficiency in Microsoft Office Suite, regulatory databases, tracking tools, SAP, TrackWise, FDA eSTAR, ESG/eMDR workflows, and GUDID/UDI-related systems.
• Ability to interpret technical, scientific, complaint, and product information.
• Experience in project coordination and managing multiple deadlines in a regulated environment.

This position is within a large medical device company, working in a dynamic and busy team environment with tight deadlines. The day-to-day activities can change frequently, requiring adaptability and strong teamwork skills.

This is a Contract position based out of Vernon Hills, 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 Vernon Hills,IL.

This position is anticipated to close on Jul 31, 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 View email address on ziprecruiter.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.