Quality Engineer

Job Title: Quality EngineerJob Description The Quality Manager is a leadership position responsible for contributing significantly to the Quality Assurance and Regulatory team. In this role, you will be a critical team member contributing to the execution of the company strategy and Quality Management System (QMS) for an evolving medical device company. This role provides Regulatory Affairs leadership with significant time spent managing product regulatory strategy, licensing, market authorization, and registration tasks and documents. You will maintain regulatory filing documents required by various countries and jurisdictions and work alongside cross-functional management teams to support products, services, and Quality Systems. Day to day responsibilities: - Understand and perform duties and responsibilities according to the company's QMS - Lead and execute regulatory strategies to protect and enhance profitability - Develop, implement, maintain, and improve regulatory processes ensuring compliance with all applicable regulatory requirements - Provide regulatory leadership on new product registrations, modified/enhanced products, transferred products, and acquisition activities - Perform and/or direct coordination and preparation/submission of any/all documents for regulatory submissions, inspection responses, and regulatory agency notifications when required - Provide direction and coaching to specialists to meet regulatory requirements as scheduled and resolve technical or operational issues - Collaborate with external regulatory authorities, competent authorities, authorized representatives/sponsors, importers/distributors, and notified bodies partnering with cross-functional stakeholders to ensure alignment and effective execution of regulatory strategy to achieve business objectives - Lead interactions with regulatory agencies as part of strategy development and support of regulatory application and document reviews - Provide guidance to all team members on regulatory requirements for planning and contingencies ensuring compliance with all applicable regulations - Provide status reports to executive management - Support internal quality and external regulatory authority or notified body audits as required - Perform regulatory review and approval of product and manufacturing changes for compliance with applicable regulations when required - Continually provide and contribute towards company and process improvements to the QMS Hard Skills Bachelor's degree in Engineering Prior experience with regulatory affairs / regulatory compliance Experience working within medical device or pharmaceutical industry (preferably 3+ years) Soft Skills Leadership experience in leading people and/or projects Ability to work cross-functionally Strong problem-solving skills Job Type This is a Contract-to-Hire position with a duration of 12 Month(s). Work Site This is a fully on-site position in Schoolcraft, Michigan. Work Environment You will work 40-45 hours a week and report to the Director of QA/RA. Occasional evening work may be required for correspondence with customers, distributors, and regulatory bodies. You will work cross-functionally with engineering and lead another QA/RA engineer on the team. 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 [email protected] (%[email protected]) for other accommodation options.