Job Description
We are seeking a dedicated QA Risk Manager to oversee risk processes throughout the product lifecycle, ensuring compliance with standards and regulatory requirements. This role involves collaboration with cross-functional teams, focusing on product quality, process reliability, new product development, validation, complaint investigations, and CAPA support. The position requires providing regular guidance to ensure adherence to risk management procedures and regulations.
ResponsibilitiesPlan and execute product risk management activities in a matrixed environment.Lead cross-functional discussions with R&D and design team members to identify, estimate, evaluate, control, and document product hazards.Monitor risk controls and verify their effectiveness throughout the product lifecycle.Conduct periodic reviews of risk management processes and quality system deliverables.Lead remediation efforts for updating risk management documents and implementing risk processes.Evaluate risk acceptability based on analysis outcomes and lead efforts to identify and document risk control measures.Perform and document Risk Reviews to communicate results to cross-functional teams.Lead internal and external audits for risk-related matters.Make recommendations to management regarding the adequacy and effectiveness of the QMS.Support the QA team with risk management responsibilities.Mentor and coach team members on risk management processes.Essential SkillsMinimum of 5 years’ experience in risk management, quality assurance, and regulatory compliance in the life sciences industry.Experience with IVD and/or medical devices is preferred.Strong knowledge of US, EU, and international regulations regarding risk management.Strong planning, communication, project management, analytical, organizational, and time management skills.Additional Skills & QualificationsCompleted undergraduate degree in life science, engineering, biomedical or relevant field.Certifications in Risk Management, Quality Assurance, Quality Engineering are preferred.ASQ (CQA, CQE, etc.) or Lead Auditor Certification preferred.Sound knowledge of quality engineering principles including risk management, reliability engineering, process and systems validation, root cause investigation, trend analysis, and statistical methods.Strong leadership and interpersonal skills.Demonstrated adaptability, flexibility, independence, and resourcefulness.Work Environment
This role is based in the Chicago/Lake Forest/Schaumburg and Dallas areas, with a preference for candidates accessing one of the facilities in these locations. For exceptional candidates, remote work is considered. If local, the expectation is to be in the office at least two days a week. Direct interaction with matrix partners is encouraged to foster effective working relationships.
Pay and Benefits
The pay range for this position is $70.00 - $80.00/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 Dallas,TX.
Application Deadline
This position is anticipated to close on Aug 7, 2025.
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 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 due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.