Quality Associate II - Onsite Weekdays

Zvh; Kentucky; On-site; USD 88,000 - 122,000; Full time

Benefits offered by this job

Health coverage

Dental coverage

401(k) plan

ESPP

Job summary

Baxter is seeking a Compliance & Records Management QAII at the Medina, NY site. The role focuses on QA compliance, internal/external audits, and managing the global entity review and periodic review processes to ensure regulatory alignment and top quality across operations.

Responsibilities include leading audit readiness, maintaining the Quality Management System (ISO 13485, 21 CFR Part 820), training staff, and coordinating with cross-functional teams to drive continuous improvement in

Qualifications

• Bachelor's degree required.
• MS in science/engineering a plus.
• Minimum of 3+ years of experience in Quality with emphasis on oversight of regulation and compliance in a medical device/pharmaceutical setting.
• Must be experienced with interpreting quality system regulations.
• Audit experience is preferred.
• Knowledge of FDA regulations and ISO 13485.
• Proficient with Microsoft Office Suite.
• Strong verbal and written communication, problem solving and conflict resolution skills.
• Ability to manage multiple priorities with minimal supervision.

Responsibilities

• Ensure compliance with Regulations and corporate processes to achieve business results.
• Develop and maintain the Quality Management System (QMS) per regulatory standards (ISO 13485) and business needs.
• Understand and ensure conformance to FDA QSR (21 CFR Part 820), ISO 13485:2016, Canadian Medical Devices Regulations, and Baxter policies.
• Manage site certifications and liaise with external bodies on registrations.
• Oversee audit lifecycle: planning, scheduling, reporting, CAPAs, and NCRs.
• Write, review, and revise SOPs to meet regulatory requirements.
• Serve as SME in Quality compliance and provide training to staff.
• Lead Audit Readiness efforts and the internal audit program.
• Manage global compliance programs like Global Entity Review and Periodic Review.
• Analyze QMS KPIs for management reviews and drive continuous improvement.
• Support investigation activities and CAPA closure.
• Other duties as assigned.

Skills

Bachelor's degree

MS in science/engineering

Quality oversight

Regulatory knowledge

FDA regulations

ISO 13485

Audit experience

Root cause analysis

Document control

Communication skills

Education

Bachelor’s degree

MS in science/engineering

Tools

Microsoft Office

Job description

About Baxter

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.

Role Overview

Your role at Baxter The Compliance & Records Management, QAII is responsible for site QA Compliance, Internal/External Audits, Site Audit Readiness and all aspects of hosting Audits, Regulatory Intelligence (GOC), Management of the Global Entity review and Periodic Review processes, QA site Model, and other Quality System items as assigned. Main responsibilities include ensuring compliance with Regulations and corporate processes. Additional responsibilities related to Records Management include serving as the Site Records Management Coordinator and Subject Matter Expert. Important: This position is located in Medina, NY and is designed as an onsite role, with an encouraged presence of five (4) days per week to foster collaboration, innovation, and connection across the team. Baxter is seeking candidates who reside within a reasonable commuting distance and are able to regularly support the business through in-person engagement and partnership at the Medina site.

Key Responsibilities

• This position’s primary responsibility is ensuring compliance with Regulations and corporate processes such that desired business results are achieved.


• Develop and sustain the Quality Management System in line with the required regulatory and industry standards (ISO 13485) and business requirements.


• Understand and ensure conformance to regulations per FDA Quality System Regulation (21CFR Part 820), ISO 13485:2016, Canadian Medical Devices Regulations SOR/98-282, as well as Baxter Global Policies and Procedures applicable to elements of the Quality System.


• Manage site certifications, external registration requirements. Liaise with external bodies on matters relating to registration.


• Manage various aspects of the audit lifecycle including planning, scheduling, notification, executing, hosting, issuing reports, evaluating responses, requesting clarifications, issuing and closing CA/PA’s.


• Write, review, analyze and revise Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc.


• Serve as Subject Matter Expert (SME) in Quality compliance by maintaining a high level of expertise in current regulatory requirements.


• Provide training and coaching to local employees and others as needed on relevant area(s).


• Assist other quality areas in the successful performance of these activities when required.


• Lead Audit Readiness efforts for the site and ensures compliance to regulatory requirements.


• Manage the site Internal Audit Program, participate in audits and/or qualify/oversee alternate Site auditors, plans for corrective and preventive actions related to internal audit findings or gaps identified in the QMS.


• Manage Site Compliance programs such as Global Observation Certification, Global Entity Review, and Periodic Review.


• Strategize quality improvement activities in collaboration with other departments.


• Manage activities of self in achieving defined quality goals in an efficient, accurate and timely manner.


• Provide detail analysis of the QMS KPIs for management review meetings and other platforms as needed.


• Balance cost, quality, people, and delivery objectives to meet plant goals utilizing standard enterprise management system.


• Ensures KPIs are met by working to overall plan, including management of, and reporting.


• Support in failure investigation activities (CAPA projects) to identify the root cause, develop appropriate corrective/preventive actions and approve CAPA’s, NCR’s.


• Other duties, tasks or projects as assigned.

Records Management Duties

• Maintaining an inventory of stored Records, ensuring Records are indexed and tracked for ease in retrieval, managing Records submitted to and/or stored with third party storage suppliers and evaluating Records to determine their destruction eligibility.


• Maintain an inventory of stored Records.


• Ensure Records are indexed and tracked for ease in retrieval.


• Ensure Records are archived/stored in appropriate locations (both electronic and physical).


• Track storage submissions and retrieval activities for records submitted to and/or stored with offsite storage providers.


• Monitor/adhere to Legal Hold Orders.


• Annually evaluate Records to determine their destruction eligibility.


• Periodically (at least annually) review trigger dates to enter known dates that have occurred.


• Prepare and route destruction eligibility reports/lists for review by Functional Leaders.


• Upon approval, destroy Records in a timely fashion in compliance with Baxter’s policies and procedures.


• Other duties, tasks or projects as assigned.

Required Qualifications

• Bachelor’s degree required.


• MS in science/engineering a plus.


• Minimum of 3+ years of experience in Quality with emphasis on oversight of regulation and compliance, or related field with a medical device/pharmaceutical company or similar regulated industry, preferred.


• Must be experienced with interpreting quality system regulations.


• Audit experience is preferred.


• Working knowledge of Quality Systems and related requirements and standards, including 21 CFR Part 820, ISO 13485, preferred.


• Knowledge of risk management, root cause analysis, corrective and preventive action and document control.


• Demonstrated use of quality and root cause analysis tools, principles, and methodologies including statistical tools.


• Proficient with computers and in the use of Microsoft Office Suite.


• Strong verbal / written communication skills, problem solving and personal conflict resolution skills.


• Strong attention to detail with the ability to independently organize workload, perform under strict deadlines and changing priorities with minimal supervision.


• Project management skills and must be able to handle multiple projects concurrently.


• Ability to communicate with all levels within the organization.


• Able to demonstrate responsiveness to customer needs, within job scope.


• Knowledge of Food & Drug Administration (FDA) Regulations and application of Good Manufacturing Practices.


• Comprehension of design methodology, product configuration and complex manufacturing processes.


• Ability to excel in a team-oriented environment.

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. While performing the duties of this job, the employee: Must be able to sit, stand, bend, stretch and walk throughout the workday. Must be able to lift at least 20 lbs. Work well under tight deadlines.

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. This is a manufacturing environment regulated by the Food & Drug Administration (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: Wear a static protective smock and Personal Protective Equipment (PPE) at all times while in the designated work areas. Work in close proximity to other employees. Work in an environment that is temperature and humidity controlled. Work in an environment that is temperature and humidity controlled.

Location & Travel

This position is located in Medina, NY and is designed as an onsite role, with an encouraged presence of five (4) days per week.

Compensation

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 $ $88,000-$121,500 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.

Benefits

• 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.


• 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.

Legal and Diversity Statements

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.

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.