Job Title: Quality Assurance Engineer Job Description The Quality Assurance Engineer will ensure compliance with FDA and other regulatory standards for medical device manufacturing. The role involves developing and implementing quality assurance procedures, conducting audits, and managing non-conformances and CAPA processes. Additionally, the engineer will collaborate with cross-functional teams to resolve quality issues and participate in risk management activities. The position also includes maintaining quality documentation and driving continuous improvement initiatives. Responsibilities + Ensure compliance with FDA and other relevant regulatory standards for medical device manufacturing. + Develop and implement quality assurance procedures for product design, development, and manufacturing. + Conduct internal and external audits of quality systems to ensure adherence to quality standards. + Coordinate the activities for Quality Management System (QMS) review and present the supporting data and metrics. + Review and approve manufacturing process changes impacting product quality, including changes to equipment and software. + Participate in risk management activities (FMEA, risk analysis) to identify potential product risks and implement corrective actions. + Manage non-conformances, CAPA (Corrective and Preventive Action) processes, and root cause analysis. + Collaborate on the investigations of customer complaints, ensure timely and accurate closure, and issue reports back to affected customers. + Work with cross-functional teams to resolve quality issues, including R&D, manufacturing, and regulatory departments. + Develop and maintain quality documentation, including process validation protocols, technical reports, and device history records. + Monitor and analyze quality data to identify trends and drive continuous improvement initiatives. + Co-lead with R&D and Manufacturing Engineering the product, process, and software validation activities (IQ, OQ, PQ) to ensure the product meets the required specifications. + Co-lead with Sourcing the supplier qualification process and conduct regular audits to ensure that supplied components and raw materials meet quality requirements. + Provide tools and training on quality systems and procedures for internal teams. + Ensure proper calibration and maintenance of quality inspection equipment. + Other duties as assigned. Essential Skills + Bachelor's Degree in Engineering (Mechanical, Industrial, Biomedical). + 7+ years experience in quality engineering within medical devices. + Understanding of regulatory requirements including FDA 21 CFR 820. + Experience with quality management systems (master control). + Proficiency in root cause analysis and corrective action (CAPA) processes. Additional Skills & Qualifications + Master control QMS experience. + Certified Quality Engineer (CQE) or equivalent certification is a plus. + Lead auditing experience for notified bodies (China, Australia, Canada). Pay and Benefits The pay range for this position is $93000.00 - $103000.00/yr. • 35% 401K Match• 160 hours PTO• Full medical benefits• Wellness reimbursement• Childcare reimbursement• Sam Club / Costco membership reimbursement• EAP• 30% HSA match Workplace Type This is a fully onsite position in Indianapolis,IN. Application Deadline This position is anticipated to close on Feb 11, 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. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are 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 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 process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.