Manager, Quality Operations Details

Manager, Quality Operations

BAXTER - Medina, NY

Employment Type : Full-Time

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission.

SUMMARY:

This position is responsible for the Baxter-Medina Quality Management System including the Operations 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 and maintain high standards of quality to ensure root cause and preventative measures are identified and corrective and preventative actions are taken.
• Provide support for the Quality technical review/approval of department related procedural changes, and validations/protocols.
• Responsible for recruiting, training, and coaching all direct reports.

ESSENTIAL FUNCTIONS:

• 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.
• Manages the hiring, training, and development of Quality staff. Develops, coaches and mentors direct reports to achieve defined quality goals and results. Ensures that effective programs are in place for all direct reports to facilitate development and to ensure compliance to set standards. Develops direct reports to optimize resources and build team effectiveness. Apply decision-making skills in situations involving broad, pervasive and long-term impact.
• Performs other duties as assigned.

QUALIFICATIONS, KNOWLEDGE AND SKILLS REQUIRED:

• 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.
• Good project management skills.

EDUCATION/EXPERIENCE REQUIRED (minimum):

• BS degree in science or engineering.
• 5+ years experience in Quality, Manufacturing, Engineering or related field, in the medical products industry, which should include 1-2 years of supervisory experience.

PHYSICAL DEMANDS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee:

• Able to sit, stand, walk throughout the workday.
• This position may also require periodic business travel car/plane (less than 10%).

WORK ENVIRONMENT:

Work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

This is a manufacturing environment regulated by the FDA and many other work rules to prevent damage to the product we manufacture. Some of those work rules include but are not limited to:

• Wearing a static protective smock at all times while in the work area
• Working in close proximity to other employees.
• Working in an environment that is temperature and humidity controlled.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.