.. also fabricate and modify parts to make or repair machine tools or maintain industrial machines, applying knowledge of mechanics, mathematics, metal properties, layout, and machining procedures. 2nd shift position Responsibilities: Operating Machine or Equipment – Operate basic equipment and machines .. read more
<b>The Role: </b> <br> <br>ModernaTX, Inc. seeks a Director, Global Combination Product Quality Lead for its Norwood, Massachusetts location.<br> <br> <b>Here's What You'll Do: </b> <br> <ul> <li>Develop and deploy policies, standard operating procedures (SOPs), standard reports, and key performance indicators (KPIs) for management of combination product and medical device feasibility, design controls, risk management, human factors and usability engineering, process development, and verification and validation testing.<br></li> <li>Lead Quality review and approval of all technical documentation for design and development of technical and risk management documentation including planning, traceability matrix, protocols and reports, and risk assessments.<br></li> <li>Partner with Technical Development and Regulatory teams to develop and support global product submissions for Combination products.<br></li> <li>Act as global Quality representative in cross-functional forums to provide support and oversight to internal and external manufacturing and testing facilities for application of the device and combination product Global Quality Management System, policies, SOPs and Standards throughout the lifecycle of products.<br></li> <li>Coordinate deployment and application of design controls supporting risk-based continued process verification and monitoring of lifecycle product quality.<br></li> <li>Provide quality support for significant changes and issue management, such as change controls, deviations, and corrective and preventive actions (CAPAs) across company internal and external manufacturing and testing sites.<br></li> <li>Collaborate with Quality System business process owners to contribute to Global Quality Management System improvement and harmonization initiatives across Global Quality Operations.<br></li> <li>Support leadership with Combo Device compliance direction when strategizing, budgeting, and planning for expansion.<br></li> <li>Support resource planning for all operations under the Quality Management Systems (QMS) for compliance,<br></li> <li>Device development, and Device sustaining.<br></li> <li>Manage activities of direct and indirect reports (two Quality Engineers) in achieving defined quality goals in an efficient, accurate and timely manner.<br></li> <li>May telecommute up to four (4) days per week.<br></li></ul> <br> <b>Here's What You'll Bring to the Table:</b> <br> <ul> <li>Minimum requirements: Requires a minimum of a Bachelor's degree or foreign equivalent in Engineering (Any), Engineering Management, or related field and seven (7) years of progressive, post-baccalaureate experience as a Quality Engineer or related position. Alternatively, employer will accept a Master's degree in fields specified and five (5) years of progressive experience as a Quality Engineer or related role. Experience must include 5 years in the following skills:<br> <ul> <li>Supporting full Product Development lifecycle and post-market monitoring for Combination Products;<br></li> <li>Reviewing design controls documentation for various projects;<br></li> <li>Responsible for developing and maintaining Device History File (DHF), DHF Remediation and Risk Management Files;<br></li> <li>Optimizing Quality Management System (QMS) in accordance with business needs, regulatory guidelines, and quality requirements;<br></li> <li>Local and global device regulatory affairs and submissions;<br></li> <li>Providing support for internal and external audits for devices and combination products.<br></li></ul></li> <li>Position requires up to 10% domestic and/or international travel, fully reimbursed. <br></li> <li>May telecommute up to four (4) days per week.<br></li> <li>Apply at https://modernatx.wd1.myworkdayjobs.com/en-US/M_tx (Job ID: R16241) or email resume and cover letter to careers@modernatx.com with subject line: R16241<br></li></ul> <br> <b>Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:</b> <br> <ul> <li>Highly competitive and inclusive medical, dental and vision coverage options</li> <li>Flexible Spending Accounts for medical expenses and dependent care expenses</li> <li>Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities</li> <li>Family care benefits, including subsidized back-up care options and on-demand tutoring</li> <li>Free premium access to fitness, nutrition, and mindfulness classes </li> <li>Exclusive preferred pricing on Peloton fitness equipment</li> <li>Adoption and family-planning benefits</li> <li>Dedicated care coordination support for our LGBTQ+ community</li> <li>Generous paid time off, including:<br>• Vacation, sick time and holidays<br>• Volunteer time to participate within your community<br>• Discretionary year-end shutdown<br>• Paid sabbatical after 5 years; every 3 years thereafter</li> <li>Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents </li> <li>401k match and Financial Planning tools</li> <li>Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options</li> <li>Complimentary concierge service including home services research, travel booking, and entertainment requests</li> <li>Free parking or subsidized commuter passes</li> <li>Location-specific perks and extras! </li></ul> <br> <b>About Moderna</b> <br> <br>Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. <br> <br>By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.<br> <br>We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.<br> <br>As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.<br> <br>If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.<br> <br>Moderna is a smoke-free, alcohol-free and drug-free work environment.<br> <br>Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!<br> <br>Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.<br> <br>Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.<br> <br>Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.<br> <br>Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer) <br> <br>-<img src="https://counter.adcourier.com/YmJnZW5lcmljLjI2MDMwLjEyNTI0QG1vZGVybmF0eGNvbXAuYXBsaXRyYWsuY29t.gif">