Quality Associate II, Training & Document Control

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. 

Your Role at Baxter

This is where your creativity addresses challenges!

This position is responsible for Document Control and Training Requirements. Identify and assess regulatory and quality risk in activities and processes according to regulatory agency rules and guidelines and Baxter quality practices.

This position manages and maintains the day-to-day document change control process for processes related information within their department. The position also has responsibility to work closely with various managers at the facility to monitor, manage and maintain a central computerized training database of all employees at the facility.

Your Team

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.

What You'll Be Doing

Documentation:

• Ensures efficient processing of document and change management systems for the Quality Management System.

• Supervise the functional activities and employees associated with the creation, revision, issuance, review and storage of controlled quality records in compliance with GDP's. Ensure documents, forms, and records are accurate and complete.

• Ensures that records of changes to documents are maintained in accordance with regulatory requirements.

• Ensures documents of external origin (e.g., Regulations and Standards) are identified and evaluated for impact to the organization.

• Provide training, guidance and coaching in the areas of responsibility for direct reports, internal and external customers.

• Maintain Quality Metrics for document control, activities for Management Review and makes recommendations for improvement.

Training:

• Manages and monitors training completion via BaxU.

• Works with Managers and/or Lead Trainers to ensure training plans are developed for every job description and updated as necessary.

• Works with Human Resources to ensure Job Descriptions are written and updated as necessary.

• Works with other Baxter facility Learning Professionals as needed to ensure training is being managed in a uniform manner.

• Manage and communicate training metrics.

• Work with managers to organize/schedule training events as needed.

• Works with managers and external vendors to obtain Grant funding for training.

• Supports internal and external audits as needed.

What You'll Bring

• BS in business, science, or engineering is required.

• 3+ years’ experience in Quality with a medical device/pharma or other regulated industry.

• Experience in development and maintenance of a training documentation database.

• Working knowledge of other medical device regulatory requirements (US, Canada and Europe) is highly desirable.

• Excellent organizational, presentation, and verbal/written communication skills.

• Attention to detail.

• Ability to multi-task and work well under pressure.

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.

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 $76,000 - $104,500 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. 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.

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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.
                                                                                                                                                               
EEO is the Law 
EEO is the law - Poster Supplement 
Pay Transparency Policy

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.