Quality Engineer

Quality Engineer Key Responsibilities Support and maintain the Medical Device Quality Management System (QMS) in compliance with FDA and ISO requirements Ensure compliance with

FDA 21 CFR

Part 820 (QSR), ISO 13485, ISO 14971, and applicable international medical device regulations, including MDR Manage the Corrective and Preventive Action (CAPA) process from investigation and root cause analysis through implementation and effectiveness checks Maintain and update Design History Files (DHF), Technical Files, and other quality documentation to support internal and external audits Review and approve validation and verification protocols and reports to ensure compliance with regulatory and quality standards Support risk management activities, including application of

ISO 14971

principles and quality tools such as FMEA Utilize quality engineering tools including FMEA, Control Plans, and Process Flow Diagrams to support product and process quality Coordinate and support sterilization qualification and ongoing maintenance activities related to medical devices Organize and prioritize assigned quality tasks to ensure projects meet timelines and business expectations Develop, execute, and support departmental and company-wide quality training programs Prepare and maintain clear, accurate, and compliant technical documentation and reports Required Qualifications Bachelor's degree in Engineering or a related technical field, or equivalent relevant experience Experience working in an ISO-regulated and/or medical device manufacturing environment Working knowledge of

FDA 21 CFR 820

(QSR), ISO 13485, GMP, and medical device quality system requirements Hands-on experience managing CAPA activities and supporting audit readiness Experience reviewing verification and validation (V&V) documentation, protocols, and reports Strong written and verbal communication skills with demonstrated technical writing ability Proficiency with Microsoft Office applications (Excel, Word, etc.) Preferred Qualifications Background in Risk Management and application of

ISO 14971

methodologies Experience supporting sterilization qualification and validation activities for medical devices Familiarity with international medical device regulations and EU MDR Experience supporting internal and external quality audits Prior experience developing or delivering quality system training Job Type & Location This is a Contract position based out of Phillipsburg, NJ. Pay and Benefits The pay range for this position is $40.00 - $45.00/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 Phillipsburg,NJ.

Application Deadline This position is anticipated to close on Apr 2, 2026. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through: Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people Actalent is an equal opportunity employer. About Actalent Actalent is a global leader in engineering and sciences services. For more than 40 years, we've helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day. Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.