Manpower Engineering is partnering with a leader in the Medical Device industry for a Senior Quality Manager! **Job Title: Senior Quality Manager** **Location: Fridley, MN** **Pay: $135,000 - $160,000 plus 15% bonus** **Duration: DIRECT HIRE** The position acts as the Site Head of Quality responsible for leading the R&D quality team, ensuring compliance with applicable regulations, industry standards, and customer requirements for pre-market activities. This position will provide overall quality engineering strategy and objectives for new product development and serial production as well as process improvements to the quality management systems. The role plays a crucial role in fostering a culture of quality excellence, promoting problem-solving, and driving continuous improvement across the organization. As a leader, you will oversee a team of professionals, providing mentorship, coaching, and guidance to ensure the achievement of performance targets and strategic objectives at both the department and organizational levels. This position entails serving as the representative of the Fridley quality department to senior management, external entities, and regulatory authorities. It includes the direct oversight of White Bear Lake and Fridley R&D quality and indirect oversight of Fridley quality systems. The role necessitates a global outlook across all quality programs and the ability to establish priorities in alignment with overarching objectives. **Key Responsibilities:** + Serving as the site Management Representative with responsibility and authority for ensuring the quality management system is effectively defined, implemented and maintained at the site in compliance with all applicable regulations and standards including ISO 13485 and FDA QSRs. + Defining quality objectives and set priorities for quality improvement initiatives in alignment with R&D and top objectives. Develop a quality strategy and establish plans to consistently monitor and achieve predetermined objectives. + Leading R&D quality including support on quality strategy/planning for new development projects, risk management, design and phase reviews, design transfer, and DHF reviews. Ensure project requirements are aligned with project scope and complexity to enhance efficiency in project execution. + Providing quality support for serial production ensuring adequate production controls to meet product and customer requirements. + Driving overall compliance in development processes, fostering a seamless connection between design control deliverables and production and process controls. + Ensuring risk management processes are fully integrated into development processes and support production and process controls. + Working with R&D to understand priorities, ensure availability of appropriate resources and support project team execution excellence. + Partnering with Operations quality and engineering to foster alignment and ensure a successful transfer to production at any receiving site. + Coordinating management reviews, present performance data, identify improvement opportunities, and aligning on overall QMS effectiveness. + Identifying areas of QMS to improve new product development project speed and efficiency and implement action plans to address them. + Engaging with cross-functional teams to establish quality, reliability and product development strategies. Identify areas for improvement and develop action plans to address them. + Coordinating and participating in internal and external audits to monitor the effectiveness of quality systems. Ensuring all corrective actions are effective and verified. + Providing support and oversight for high-risk and/or high-priority quality issues, assisting in complex decision-making and problem-solving to ensure team and organizational success. + Developing communications, education and training to instill a quality always mindset in every coworker activity. **Required Qualifications:** + Bachelor's degree in Engineering or related scientific discipline. + Minimum of 7 years related professional level experience. + Minimum of 2 years of supervisory experience. + In depth knowledge of regulatory requirements and their interpretation such as current Good Manufacturing Practices. + Medical device manufacturing, EN ISO 13485 and/or FDA QSR and/or MDSAP standards experience strongly preferred. + Internal audit and Six sigma working knowledge preferred. ASQ certified QE a plus; Must have working technical knowledge of systems and statistics. + Promotes continuous improvement, respectful of coworkers, embraces high quality standards, and pays attention to detail. + **Benefits:** • Comprehensive Medical, Dental, and Vision plans.• PTO/Vacation• Paid Parental Leave• 401k with Company Match 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 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th 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.