Sr Quality Systems Specialist - Design Control_

Top Needs:+ Design Control+ Class III medical device experience+ Understanding of FDA regulations 21 CFR 820 210/211 as applicable and Part 11, specifically related to CAPA requirements.Team You’ll Be Supporting: The Structural Heart and Aortic integrated operating unit focuses on minimally-invasive approaches to restore proper structure and function of the heart and aorta.Day-to-Day Responsibilities:+ Participate in Quality System process activities across multiple sites, including quality system projects and initiatives.+ Understand FDA regulations (21 CFR 820 210/211) and Part 11, with a specific focus on CAPA.+ Manage CAPA activities, including corrective actions and effectiveness strategies.+ Conduct root cause investigations for Quality System compliance issues and analyze investigation findings.+ Support the development and implementation of Quality System procedures.+ Travel locally and internationally for approximately 10 days.Hard Skills:+ Design Control+ Class III medical device experience+ Understanding of FDA regulations (21 CFR 820 210/211) and Part 11+ Familiarity with Quality System documentation systems (e.g., Agile) and audit documentation systems (e.g., Trackwise)+ Ability to review technical documentation+ Knowledge of quality tools and process improvement techniquesSoft Skills:+ Strong influence management skills+ Ability to collaborate constructively across all functions of the organization+ Skill in educating others about Quality Systems and the Audit programJob Type: This is a contract position with a duration of 52 weeks. This role can be remote (for the right experience), but hybrid is ideal.About ActalentActalent 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 & InclusionAt 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 peopleThe 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.