Quality Assurance Engineer

Job Title: Design Assurance EngineerJob DescriptionThis hands-on Design Assurance Engineer position focuses on leading an ISO-compliant risk management remediation initiative within a regulated medical device environment. You will take ownership of remediation planning and execution, drive alignment of risk management activities with design controls and post-market surveillance, and close identified gaps to ensure compliance readiness. The role is highly execution-focused and well-suited for a contributor who enjoys personally remediating risk files, updating procedures, and collaborating closely with cross-functional teams in a fast-paced, compliance-driven setting.ResponsibilitiesLead end-to-end remediation of risk management processes and risk files to ensure alignment with ISO-based risk management requirements and current regulatory expectations.Plan, own, and execute the overall risk remediation strategy, including defining deliverables, timelines, and priorities for closing identified gaps.Review, update, correct, and complete existing risk files to address deficiencies and ensure they meet compliance and audit readiness standards.Integrate risk management activities with design controls, Design History Files (DHFs), and product lifecycle documentation to maintain traceability and consistency.Collaborate closely with Quality Assurance, Regulatory Affairs, Engineering, and Post-Market Surveillance teams to gather inputs and ensure risk documentation reflects design, regulatory, and field performance information.Ensure risk management outputs appropriately incorporate post-market data, including complaints, trending, and corrective or preventive action (CAPA) inputs when applicable.Drive documentation-heavy activities with high attention to detail, ensuring all risk-related records are accurate, complete, and audit-ready.Support preparation for regulatory inspections, audits, and internal assessments by providing clear, well-structured risk management documentation.Identify process improvements in risk management and design assurance practices and contribute to updates of procedures and work instructions.Work independently with minimal supervision, taking ownership of remediation deliverables and driving projects to closure within agreed timelines.Essential SkillsMinimum of 4 years of robust, hands-on experience in medical device risk management, with a preference for 5–8 years of experience.Direct, practical experience applying ISO-based risk management principles in a regulated medical device environment.Proven background in risk file remediation, including personally updating, correcting, and closing gaps in risk documentation rather than only providing theoretical guidance.Strong understanding of design controls and how risk management activities integrate across the product lifecycle and DHFs.Demonstrated experience working cross-functionally with Quality Assurance, Regulatory Affairs, Engineering, and Post-Market Surveillance teams.Ability to work independently, manage priorities, and fully own risk remediation deliverables from planning through completion.High attention to detail and strong documentation skills suitable for a compliance-driven, documentation-heavy role.Additional Skills & QualificationsExperience supporting FDA and EU MDR regulatory frameworks for medical devices.Prior involvement in audit findings, gap assessments, or remediation programs related to risk management or design assurance.Exposure to post-market trending, complaints handling, or CAPA processes and how they feed into risk files.Comfort operating in a fast-paced environment with clear, outcome-focused deliverables.Strong collaboration and communication skills to work effectively with design, regulatory, quality, and post-market teams.Work EnvironmentThis role operates within a fast-paced, compliance-driven medical device environment that emphasizes rigorous documentation and cross-functional collaboration. The position offers on-site work in Louisville, CO, with flexibility for hybrid or fully remote arrangements, enabling you to contribute effectively regardless of location. You will work closely with design, regulatory, quality, and post-market teams, often engaging in detailed reviews of technical and quality documentation. The environment favors proactive, hands-on contributors who enjoy owning visible compliance initiatives and delivering clear, measurable remediation outcomes.Job Type & LocationThis is a Contract to Hire position based out of Louisville, CO.Pay And BenefitsThe pay range for this position is $55.00 - $72.00/hr.RequirementsEligibility 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 TypeThis is a fully remote position.Application DeadlineThis position is anticipated to close on May 29, 2026.About ActalentActalent 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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.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.