Medical Device Quality And Compliance Specialist

Job Description

Job Description

Job Title: Medical Device Quality and Compliance Specialist Job Description

As a Medical Device Quality and Compliance Specialist, you will be responsible for handling complaints, conducting MDR reportability assessments, supporting post-market surveillance, ensuring audit readiness, and managing risk-based documentation. You will collaborate cross-functionally with teams in Quality, Regulatory Affairs, Clinical, R&D, Operations, and other business stakeholders. This role requires practical exposure to FDA medical device reporting expectations, including 21 CFR Part 803, complaint-handling requirements, quality-system documentation, eMDR/FDA reporting workflows, regulatory decision rationale, and maintaining audit-ready records.

Responsibilities

• Handle and assess complaints related to medical devices.
• Conduct MDR reportability assessments and support post-market surveillance activities.
• Ensure audit readiness and manage risk-based documentation effectively.
• Collaborate with cross-functional teams including Quality, Regulatory Affairs, Clinical, R&D, Operations, and business stakeholders.
• Maintain audit-ready records and ensure compliance with FDA medical device reporting expectations and 21 CFR Part 803.

Essential Skills

• Experience in medical device quality assurance and regulatory compliance.
• Strong technical writing skills and ability to create quality-system documentation.
• Proficiency in audit, technical writing, corrective action plans, and complaint handling.
• Familiarity with eMDR/FDA reporting workflows and regulatory decision-making.
• Ability to interpret and translate technical, scientific, complaint, and product information.

Additional Skills & Qualifications

• Proficiency with Microsoft Office Suite, including Excel, Word, and PowerPoint.
• Experience with regulatory databases, tracking tools, complaint systems, SAP, TrackWise, and FDA eSTAR.
• Ability to manage multiple deadlines in a regulated environment.
• Strong analytical thinking, attention to detail, and organizational skills.

Work Environment

This role is set within a large medical device company, where you will work as part of a large team with tight deadlines. The work environment is dynamic, with day-to-day tasks frequently changing, providing a busy and fast-paced atmosphere.

Job Type & Location

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

Pay and Benefits

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)

Workplace Type

This is a hybrid position in Vernon Hills,IL.

Application Deadline

This position is anticipated to close on Aug 14, 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 us.fitly.work 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.