Our client, a leader in the medical device industry, is seeking a Senior Quality Engineer to join their team. As a Senior Quality Engineer, you will be part of the Quality Engineering department supporting cross-functional product development teams. The ideal candidate will have exceptional attention to detail, strong communication skills, and a creative problem-solving mindset which will align successfully in the organization. **Job Title:** Senior Quality Engineer **Location:** Bellevue, WA (Hybrid, onsite 3 days a week preferred) **What's the Job?** + Provide Quality Engineering leadership for software and hardware product development teams, ensuring compliance with design control and risk management. + Establish and nurture strong relationships with cross-functional product development team members to optimize the success of development projects. + Lead the development and maintenance of the Risk Management File (RMF), including risk management plans, hazards analysis, and risk management reports. + Provide Quality Engineering input, review, and approval of the Design History File (DHF) and associated documentation. + Support the successful transfer and hyper-care phase of design modifications into production and field deployment. **What's Needed?** + 8+ years of progressive Quality Engineering experience in the medical device industry with hands-on support for hardware and software development. + Experience with FDA CFR 820, ISO 13485, ISO 14971, and IEC 60601 series. + Exceptional verbal and written communication skills and presentation skills. + Proficient in Microsoft Office, Adobe Acrobat, and statistical analysis tools. + Must be comfortable working in a high-growth company with rapidly evolving needs. **What's in it for me?** + Opportunity to lead and influence quality engineering practices in a dynamic environment. + Collaborate with talented professionals across various disciplines. + Engage in meaningful work that impacts patient safety and product quality. + Professional development opportunities in a rapidly evolving industry. + Work in a hybrid model that promotes work-life balance. **Upon completion of waiting period consultants are eligible for:** + Medical and Prescription Drug Plans + Dental Plan + Vision Plan + Health Savings Account + Health Flexible Spending Account + Dependent Care Flexible Spending Account + Supplemental Life Insurance + Short Term and Long Term Disability Insurance + Business Travel Insurance + 401(k), Plus Match + Weekly Pay If this is a role that interests you and you'd like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you! **About ManpowerGroup, Parent Company of: Manpower, Experis, Talent Solutions, and Jefferson Wells** _ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands –_ **_Manpower, Experis, Talent Solutions, and Jefferson Wells_** _–_ creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2023 ManpowerGroup was named one of the World's Most Ethical Companies for the 14th year - all confirming our position as the brand of choice for in-demand talent. ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.