Site Quality Leader (Irvine, CA)

SOLVENTUM • Irvine, CA

1d • Onsite

About The Position

At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best. Because people, and their wellbeing, are at the heart of every scientific advancement we pursue. We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Because at Solventum, we never stop solving for you. The Impact You’ll Make in this Role As the Site Quality Leader for the Irvine, California facility within the Dental Solutions Business, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by: Serving as the manufacturing site Quality Management Representative and leading the site Quality team by providing expert-level Quality function leadership, guidance, and direction to your team on the Quality Body-of-Knowledge for end-to-end product and process quality assurance programs, procedures, and controls from new product development through post-market improvements for medical devices Leading the Irvine Site Quality team by directly supervising quality engineering professionals and supervisors (including objective setting and performance management) as your team effectively and efficiently interprets product and performance data and trends, responds to customer needs and requirements, resolves nonconformances, and interprets and supports business objectives to drive continuous improvement by defining guidelines, methods, and priorities, initiating and approving improvement projects to enhance product and process capabilities, and creating solutions for complex and multi-faceted problems Identifying and leading improvement opportunities to proactively ensure compliance to all applicable internal, domestic, and international quality regulations and competent authority requirements, including but not limited to, US 21 CFR 820, ISO 13485, ISO 14971, EU MDR, Health Canada, ANVISA, COFEPRIS, MHRA, TGA, NMPA, PMDA, etc. Providing guidance to internal teams and cross-functional personnel in the development and implementation of quality strategies for regulated medical devices, while maintaining effective Quality metric performance by defining and executing activities to enhance product quality, reduce process variances, and resolve signals and decreases in performance Providing influential peer leadership as part of the Site Leadership Team to drive improvements in compliance, risk management, product and process quality, quality culture, and predictive quality using industry-leading technologies, systems, and improvement tools for process control & monitoring, structured problem solving, and trend analysis with timely and effective signal resolution

Requirements

• Bachelor’s degree or higher AND (10) years of Medical Device, Pharmaceutical, or Combination Product experience in a Quality function in a private, public, government or military environment.
• Three (3) years of quality management experience, demonstrating effective team leadership, adherence to compliance standards, value optimization, and mitigation of operational risks.
• Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).

Nice To Haves

• ASQ Certified Quality Engineer, ASQ Certified Manager of Quality/Organizational Excellence, or Certified Six Sigma Black Belt
• Skills including, but not limited to, Competent Authority Interaction and Influence, External Audit Readiness & Management, Medical Device, Nonconforming Material Control, Customer Interaction and Support, Quality Engineering, Process Validation, Process Control & Monitoring, Risk Reduction, Continuous Process and Product Improvement, Field Actions & Recalls, and Organizational Leadership
• Demonstrated successful organizational influence in areas including, but not limited to, compliance excellence, continuous improvement, product-related risk mitigation, and process capability and efficiency enhancement
• Strong verbal and written communication skills with the ability to provide diligent, concise, and fact-based communication to Executive Management, cross-functional peers, and your direct report team
• Strong leadership, decision-making, problem-solving, continuous improvement, and management skills with the demonstrated ability to create momentum and deliver results in a timely manner by prioritizing personal workloads, as well as providing guidance, direction, and oversight to others

Responsibilities

• Serving as the manufacturing site Quality Management Representative and leading the site Quality team by providing expert-level Quality function leadership, guidance, and direction to your team on the Quality Body-of-Knowledge for end-to-end product and process quality assurance programs, procedures, and controls from new product development through post-market improvements for medical devices
• Leading the Irvine Site Quality team by directly supervising quality engineering professionals and supervisors (including objective setting and performance management) as your team effectively and efficiently interprets product and performance data and trends, responds to customer needs and requirements, resolves nonconformances, and interprets and supports business objectives to drive continuous improvement by defining guidelines, methods, and priorities, initiating and approving improvement projects to enhance product and process capabilities, and creating solutions for complex and multi-faceted problems
• Identifying and leading improvement opportunities to proactively ensure compliance to all applicable internal, domestic, and international quality regulations and competent authority requirements, including but not limited to, US 21 CFR 820, ISO 13485, ISO 14971, EU MDR, Health Canada, ANVISA, COFEPRIS, MHRA, TGA, NMPA, PMDA, etc.
• Providing guidance to internal teams and cross-functional personnel in the development and implementation of quality strategies for regulated medical devices, while maintaining effective Quality metric performance by defining and executing activities to enhance product quality, reduce process variances, and resolve signals and decreases in performance
• Providing influential peer leadership as part of the Site Leadership Team to drive improvements in compliance, risk management, product and process quality, quality culture, and predictive quality using industry-leading technologies, systems, and improvement tools for process control & monitoring, structured problem solving, and trend analysis with timely and effective signal resolution

Benefits

• Solventum offers many programs to help you live your best life – both physically and financially.
• To ensure competitive pay and benefits, Solventum regularly benchmarks with other companies that are comparable in size and scope.
• Medical, Dental & Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences and Retirement Benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level