Manager, QA Compliance

This is whereyour 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 position is responsible for oversight and management of the Quality Management System and Quality Compliance

Quality Management System (QMS). The primary responsibility of this role is the establishment and maintenance of the Baxter-Medina QMS to ensure compliance with all applicable QMS requirements, including 21 CFR Part 820 and related FDA requirements, ISO 13485:2016 and related regulations and standards, other relevant international requirements, as well as Baxter corporate QMS requirements. This individual works closely with Management with Executive Responsibility (MWER) and Quality Management Representative (QMR) to ensure that:

What You'll Be Doing

• The appropriate organizational structure, resources, responsibilities and processes, policies, procedures, documents and records have been established and are maintained to meet the QMS requirements.

• The QMS is suitable for all operations including, manufacture, packaging, labeling, storage, and distribution; and

• The QMS is effective in maintaining the quality, safety and effectiveness of Baxter-Medina products.

Document Control & Records Management. This role is responsible to establish and maintain an effective document control system, and to ensure all documents required under the QMS are established and maintained appropriately. This role is also responsible to establish and maintain an effective records management system, and to ensure all records required under the QMS are maintained appropriately.

Training. This role is responsible to establish and maintain an effective personnel training system to ensure training requirements are established and maintained and training is conducted and documented in a timely and effective manner.

Internal Quality Audit. This role is responsible for establishing and maintain an effective internal audit system to ensure the QMS complies with established QMS requirements and determine its effectiveness.

Establish metrics and key performance indicators (KPIs) and ensure appropriate data is available to measure the effectiveness of quality assurance efforts and track progress towards digital transformation goals.

• Manage a team of quality assurance professionals, providing guidance, mentorship, and support to drive continuous improvement.

• Stay current with industry trends, emerging technologies, and best practices in quality assurance and digital transformation.

• Communicate effectively with senior leadership and stakeholders, providing regular updates on quality assurance activities, milestones, and achievements.

• Drive a culture of quality and innovation, fostering collaboration, creativity, and accountability across the organization.

• - Ensures compliance with all applicable regulatory and corporate QMS requirements.

• Manages direct reports and works closely with all other functions to maintain the suitability and effectiveness of the QMS.

• Ensures the proper review and approval of all new and revised QMS documents prior to issuance including periodic review of documents for adequacy or necessary updates.

• Establishes and maintains appropriate metrics and measures, including for document control, records management, change control, and ensures data analyses is in accordance with applicable procedures to identify issues and trends to initiate and execute corrective and preventive action where indicated.

• Supports external quality audits, including regulatory inspections, as the QMS subject matter expert and through provision of document control and records management services.

• Manages the internal quality audit process to ensure audits are conducted when required by qualified individuals, corrective action is taken where necessary, audit results are documented and reported appropriately.

• Ensures the efficiency, effectiveness and compliance of the document change control process, and that change control records/files are clear, concise and complete, and include documented premarket regulatory impact assessments where indicated.

• Ensures all records (hard copy and electronic) are appropriately identified, and stored in a controlled and secure manner, and are retrievable in a compliant, efficient and timely manner.

• Performs other duties as assigned

What You'll Bring

• BS degree in science or engineering.

• Minimum of 5-8 years of experience in Quality, Manufacturing, Engineering or related field in the medical products industry, which should include 1-2 years 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.

• 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.

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%).

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $112,000 - $154,000 - annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

\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 accommodation 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:

• Working in close proximity to other employees.

• Working in an environment that is temperature and humidity controlled.

US Benefits at Baxter (except for Puerto Rico)

This is where your well-being matters. 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.For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter

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.

Know Your Rights: Workplace Discrimination is Illegal

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

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