Sr. Quality Engineer
Actalent
Key Responsibilities and Duties
• Lead and execute product and process validation activities, including IQ/OQ/PQ protocols, to ensure compliance with internal procedures and regulatory requirements. Provide inputs to process validation activities and process risk decisions (PVMP/PFMEA).
• Conduct thorough risk assessments using tools such as FMEA, risk matrices, and root cause analysis; develop mitigation strategies and ensure ongoing risk control.
• Analyze and trend non-conformances, deviations, and CAPAs to identify systemic issues; lead investigations and implement effective corrective and preventive actions.
• Support sustaining engineering projects, including product/process changes, equipment upgrades, and capacity expansions, ensuring alignment with quality and compliance standards.
• Collaborate cross-functionally with Engineering, Manufacturing, Regulatory Affairs, and Supply Chain to drive quality initiatives and resolve quality-related issues.
• Define and monitor key quality performance indicators (KPIs); prepare and present reports to management with actionable insights.
• Review and approve change controls, validations, and quality documentation as a subject matter expert.
• Continuously improve quality systems, tools, and processes to enhance product quality and operational efficiency.
• Ensure adherence to applicable standards and regulations (e.g., ISO 13485, FDA 21 CFR Part 820, MDSAP), and lead audit readiness activities.
• Support Quality system training and participates in the development of training programs regarding all aspects of producing quality products.
Seeking candidate with:
+ Bachelors degree in a life science or engineering discipline.
+ Medical device manufacturing experience
+ 2+ years of experience for the QE II opening and 5+ years experience for the SR role.
+ CAPA and nonconformance experience
+ Validation experience IQ,OQ,PQ
Pay and Benefits
The pay range for this position is $50.00 - $60.00/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 fully onsite position in Northfield,IL.
Application Deadline
This position is anticipated to close on Jul 3, 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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.
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