Senior Manager, Quality

Senior Manager, Quality

Heraeus Medevio

Location Fridley – Minnesota

Permanent

Full Time

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 at White Bear Lake and Fridley and serial production at Fridley. 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 Medevio objectives.

What You Get To Do Every Day:

• 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 Medevio 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 Medevio 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.
• Other duties may be assigned as required.

What We’re Looking For:

• 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.
• Ability to clearly communicate to a variety of audiences.
• 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.
• Distinguished and consistent display of leadership by example in accordance with Medevio Core Values.  Leads by participative management.

Medevio is committed to providing competitive total compensation and benefits packages. The expected base salary hiring range for this position is between $130,000.00 and $160,000.00, based upon a full-time schedule. This is a good faith estimate on the applicable range. Base salaries are determined by taking a variety of factors in account, including, but not limited to, candidate qualifications, geographic locations, market conditions and internal equity. This position is bonus eligible, with a target bonus of 15% of base salary depending upon company and individual performance. Our total compensation package also includes eligibility for comprehensive medical, dental, and vision coverage, a 401(k) plan with company match, education reimbursement, paid parental leave and paid time off.