Senior Manager, Quality

Baxter International Inc. • Medina, NY

1d • $136,000 - $187,000

About The Position

This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride. Your Role at Baxter This is where your creativity addresses challenges You are creative, thorough, and a heads-down do-er. You embrace a challenge and truly apply the collaborative powers of your team to produce great results. You are motivated by work that is never the same from one day to the next. As a Senior Manager, you are unafraid of navigating through necessary internal processes to facilitate a product you deeply believe in. You can absorb and act on complex procedures and data and train your team or peers if needed. You take pride in getting things done quickly without sacrificing safety or quality. Your Team at Baxter Within Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it is sure to touch a portion of our global operation. The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always. The Quality function values both working together as a team and independently. We draw energy from working in a plant or an office where there are opportunities to collaborate. As the company evolves, so does the way our team approaches work as it strives to create top-of-the-line products. We build relationships with each other to get work done. Building these relationships is easy because we all share common traits of being reliable, ethical, and caring. We lean on our colleagues for their expertise and hold each other accountable. We feel empowered to speak up when there's a new insight or opportunity to improve something. This open dialog builds trust within the team and helps create a better product for our customers.

Requirements

• BS degree in science or engineering.
• Minimum 5 years’ experience in Quality, Manufacturing, Engineering or related field in the medical products industry.
• Minimum 1 year of supervisory experience.
• Extensive knowledge of relevant FDA, Health Canada and other international regulatory QMS requirements.
• Demonstrated knowledge of current regulatory interpretations of QMS requirements and current industry best practices.
• Ability to multi-task effectively.
• Understand simple and complex measurement equipment and their capabilities/limitations.
• Proficient in computer system use, including but not limited to Microsoft Office Suite and QMS software.
• Strong analytical and problem-solving skills.
• Ability to manage/supervise a team of employees.
• Good communication and leadership skills.
• Good interpersonal/communication/influencing/negotiation skills.

Responsibilities

• Responsible for oversight of Quality Operations, including Quality systems, Process Validation activities and resources.
• Responsible for ensuring compliance of the following Quality Operations of the facility to the Quality Manual, Health Canada, Corporate and ISO requirements: Validation, Product Release, Final Inspections, Calibration, root cause investigations.
• Partner with Quality Systems and Production personnel to ensure robust investigations are performed and mitigating actions are identified and implemented.
• Provide front line day to day management, coaching and technical support on product quality issues to ensure GMP, regulatory and procedural compliance.
• Provide support for the Quality technical review/approval of department related procedural changes, and validations/protocols.
• Responsible for hiring, training, and coaching (including performance management activities) all direct reports as well as succession planning activities for the Quality Operations team.
• Manage the activities of the Quality Operations team to ensure that quality operations are performed in compliance with all the applicable regulatory and corporate QMS requirements.
• Provides front line day to day management, coaching and technical support on product quality issues to ensure GMP, regulatory and procedural compliance and maintain high standards of quality to ensure root cause and preventative measures are identified and corrective and preventative actions are taken.
• Provides support for the Quality technical review/approval of department related procedural changes, and validations/protocols.
• Remains current with respect to regulatory trends and divisional issues.
• Partners with facilities, divisions, and regions to ensure knowledge sharing and successful implementation of Quality improvement initiatives.
• Supports and participates in internal/external quality audits, including regulatory inspections, as an overall QMS subject matter expert as well as their direct areas of responsibility.
• Serves as subject matter expert for the Medina Operational Quality and Process Validation systems.

Benefits

• Baxter offers comprehensive compensation and benefits packages for eligible roles.
• Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance.
• Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching.
• We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave.
• Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits.
• Join us and enjoy the competitive compensation and benefits we offer to our employees.

What This Job Offers

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