Site Quality Manager (Onsite - Flemington, NJ)

Solventum • Us, NJ

11d • 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 a Site Quality Manager 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: Management Representative with responsibility and authority to ensure Quality Management Systems (QMS) requirements are established, and effectively and efficiently maintained.

Requirements

• Bachelor’s Degree or higher AND seven (7) years of combined regulatory, quality, laboratory and/or manufacturing environment experience within a heath care regulated industry in a private, public, government, or military environment OR High School Diploma/GED AND eleven (11) years of combined regulatory, quality, laboratory and/or manufacturing environment experience within a heath care regulated industry in a private, public, government, or military environment
• Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).

Nice To Haves

• Master’s degree or higher in a science or engineering discipline
• People leader experience
• Proven ability to lead cross-functional teams and collaborate
• Proven ability to lead audit/inspection activities
• Experience leading continuous improvement projects
• Strong statistical acumen
• Change Management experience of programs with significant strategic importance

Responsibilities

• Conducts Operational planning to support the overall Quality strategy for the site and actively participates on the Plant Operating Committee (POC).
• Plans, organizes and directs all quality activities and policies at the site.
• Establishing leadership and shared ownership for the Quality Culture within the site.
• Assuring all products released to the market meet their specification and comply with relevant regulatory requirements (medical device and combination products).
• Applying continuous improvement methodology to drive prevention of quality nonconformances and deviations, reduced variation in product and process, improved customer satisfaction, and operational excellence across the site.
• Preparing for, managing, and following-up on quality and regulatory audits/inspections conducted by external agencies, notified bodies, customers, and internal functions.
• Guiding the plant and business with appropriate risk-based decision making around deviations and change control.
• Implementing quality and regulatory strategies aligned to global regulations and business strategic plans.
• Developing the Team to deliver solutions for highly complex and multi-faceted problems, which require ingenuity, creativity, innovation, and strong analytical skills.
• Networking effectively across all business stakeholders and sister plants within the business to share key learnings and capitalize on best practices.

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, etc.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees