Quality Project Manager

Job Title:

Quality Program Manager Job Description The Quality Program Manager leads complex quality initiatives across a portfolio of projects to achieve broad program goals within a medical device manufacturing environment. This role plans and manages program schedules from inception through delivery, defines and reports on the program roadmap and success metrics, and drives continuous improvement in cost, performance, and timelines. The Quality Program Manager oversees a team of quality engineers, manages stakeholder engagement, and ensures compliance with applicable quality and regulatory standards while proactively identifying and mitigating risks. Responsibilities Lead and manage quality programs from initial planning through successful delivery, ensuring alignment with overall business and quality objectives. Plan, implement, and maintain detailed program schedules, tracking progress, dependencies, and milestones across multiple quality projects. Define, maintain, and communicate the program roadmap, including scope, timelines, resource needs, and key success metrics. Monitor and report program status, development issues, and risks to stakeholders in a clear and timely manner. Identify, assess, and monitor areas of risk within the program and implement effective risk mitigation strategies. Drive continuous improvement initiatives to enhance cost efficiency, quality performance, and schedule adherence across projects. Build, manage, and track program budgets, ensuring resources are allocated effectively and financial targets are met. Facilitate communication and coordination among cross-functional project teams to ensure alignment and timely issue resolution. Manage stakeholder engagement and satisfaction by setting expectations, providing regular updates, and incorporating feedback into program plans. Lead a team of approximately 10 quality engineers, providing direction, coaching, and support to ensure high performance and professional development. Oversee quality assurance activities, including audits, investigations, and root cause analyses related to product discrepancies and non-conformances. Ensure effective management of non-conformances (NCMR) and product discrepancies, driving timely and thorough investigations and documentation. Lead and oversee Corrective and Preventive Actions (CAPA), ensuring robust root cause analysis, action planning, implementation, and effectiveness checks. Ensure compliance with FDA regulations, ISO standards, and Good Manufacturing Practices (GMP) within all program activities. Oversee and support change control processes to ensure changes are properly evaluated, documented, and implemented without compromising product quality or compliance. Utilize TrackWise or similar quality systems to manage investigations, CAPAs, change controls, and related quality records. Apply quality engineering principles to support product and process improvements, risk mitigation, and compliance activities. Prepare clear, accurate, and well-structured technical and quality documentation, including reports, protocols, and summaries. Maintain awareness of industry trends, regulatory expectations, and internal processes that impact quality programs and component projects. Collaborate with engineering, manufacturing, and other functions to resolve quality issues and improve product and process performance. Essential Skills Bachelor's degree. 5 to 10 or more years of relevant experience in quality, program management, or a related field. Proven experience managing quality projects or programs within a regulated environment, preferably medical devices or healthcare products. Strong quality assurance expereince, including audits, investigations, and root cause analysis. Hands-on experience with non-conformances (NCMR) and product discrepancy management. Demonstrated expertise in CAPA management, including investigation, root cause analysis, and implementation of corrective and preventive actions. Working knowledge of FDA regulations and expectations related to quality systems and medical products. Familiarity with ISO standards applicable to medical devices or healthcare products. Experience with Good Manufacturing Practices (GMP) in a manufacturing setting. Proven program management and project management skills, including scheduling, budgeting, and status reporting. Ability to coordinate multiple projects and stakeholders simultaneously in a fast-paced environment. Strong written communication and technical writing skills for clear documentation and reporting. Experience leading and developing engineering or quality teams. Proficiency with TrackWise or similar electronic quality management systems. Solid understanding of quality engineering principles and methodologies. Strong analytical and problem-solving skills, including structured root cause analysis. Effective stakeholder management and communication skills across all levels of the organization. Additional Skills & Qualifications Experience in the medical device industry or with medical products and services. quality engineering. Experience in project coordination within cross-functional teams. Demonstrated ability to drive continuous improvement in cost, performance, and schedule. Experience with risk mitigation strategies in a regulated environment. Ability to interpret and apply internal processes and best practices to complex quality programs. Work Environment This role operates on-site in a manufacturing environment that produces and markets innovative medical products and services for the healthcare industry. The facility focuses on products with inherent safety features designed to address critical healthcare challenges, such as opioid-related issues, hospital-acquired malnutrition, and hazardous drug exposure. The Quality Program Manager works closely with engineering, manufacturing, and quality teams, leading a group of approximately 10 quality engineers. The environment emphasizes regulatory compliance, use of electronic quality systems such as TrackWise, and adherence to FDA, ISO, and GMP standards. The on-site setting involves regular interaction with production areas, quality laboratories, and office spaces, with a strong culture of safety, collaboration, and continuous improvement. Job Type & Location This is a Contract position based out of Irvine, CA. Pay and Benefits The pay range for this position is $79.00 - $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 fully onsite position in Irvine,CA.

Application Deadline This position is anticipated to close on May 13, 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.