Quality Systems Manager

Job Title:

Quality Systems Manager Job Description Responsible for the effective and accurate coordination of all Documentation and Training tasks within the Quality Management System in a medical device, regulated environment. Coordinate the Document control and Training systems to ensure compliance of internal and external requirements. Evaluates Quality system elements identifies gaps and recommends issue resolution to VP of Quality and Regulatory. Ensures the implementation of the operational Quality strategy. Provides leadership in interpretation, teaching, and gains commitment and ownership of Quality initiatives. Responsibilities Oversee daily operation of Quality Systems Team. Identify, support, and develop direct reports to achieve business and quality objectives. Review and approve Change Order (CO) to product, processes, and materials. Promote and support multi-discipline teamwork, i.e., activities that support the quality management system. Support/lead the planning pipeline of quality improvement activities including initiatives to increase product quality; resolve NCMR, Customer Complaint, Audit, and CAPA (related to Operations), decrease inefficiencies and improve risk management. Foster an environment of proactive and continuous improvement approach to Quality. Coordinate daily Document Control responsibilities, including change control processes and ensuring accuracy and timely completion of all change orders for Document Control. Create and maintain documentation such as quality procedures and work instructions. Maintain the Training program, including sending Training notices, sending reminder notices, and tracking the progress of Training. Ensure documents are readily available in electronic format and accessible to all employees. Manage electronic and hard-copy archival system for controlled documents. Oversee scanning and filing of Device History records (DHR). Support external audits by providing needed documentation and potentially acting as a scribe during the process. Oversee the deviations and rework programs. Run the Internal Audit program. Serve as host for External audits. Oversee the Supplier Quality program. Participate in the onboarding process to orient new hires and provide training on the procedure management process as required. Provide metrics to monitor the company quality objectives and the quality management review process. Essential Skills Experience managing and leading teams in a medical device regulated quality systems function. Proficiency in document control training, device history records, change order, NCMR, complaints, audit, CAPA, supplier quality, 21 CFR, EU MDR. Knowledge of eQMS and Greenlight Guru. Understanding of FDA regulations, Quality System Regulations 21 CFR Part 820,

ISO :

2016, EU

MDR, ISO

:2019. 8-10 years of experience in quality assurance in the medical device industry. Experience supporting manufacturing lines. Experience working with new product launch teams. Strong analytical skills with the application of statistical methods (e.g., SPC, DOE, capability analysis, etc.). Additional Skills & Qualifications Bachelor's degree in Engineering or related Science. Experience working with suppliers and the engineering team to test, validate, and qualify new products, processes, procedures, and equipment. Work Environment While performing the duties of this job, the employee is frequently exposed to fumes or airborne particles, moving mechanical parts, and vibration. The employee is frequently exposed to a variety of varying weather conditions, trash, waste, chemicals, and other materials. The noise level in the work environment and facility grounds can be loud. This position is very active and requires standing, walking, bending, kneeling, stooping, crouching, crawling, and climbing all day. The employee must frequently lift or move items over 50 pounds. Specific vision abilities required include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus. Requires travel between buildings as well as to and from retail/wholesale suppliers. May require travel to remote locations. Job Type & Location This is a Permanent position based out of Newbury Park, CA. Pay and Benefits The pay range for this position is $129000.00 - $135000.00/yr. medical vision dental 401k PTO Workplace Type This is a fully onsite position in Newbury Park,CA. Application Deadline This position is anticipated to close on Feb 17, 2026. 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.