Supplier Quality Assurance Lead

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

Saving and Sustaining Lives at Baxter begins with the suppliers who make the many raw materials that form our products. As a Supplier Quality Assurance Lead you will have the opportunity in a high visibility role to ensure that Baxter's suppliers continue to enable our Mission by providing high quality, safe, and effective products. You will work with our Americas Raw Materials suppliers throughout their lifecycle from onboarding, maintenance, to transfer/decommissioning primarily through leading supplier audits and New Product Introduction (NPI) teams.

What you will be doing

• Set Quality system requirements to suppliers, including those for services, indirect quality relevant purchases (non-BOM), and QS requirements for suppliers in global markets.
• Perform Qualification of suppliers to medical device, pharmaceutical, combination devices, and/or biologics standards and oversee their placement on the Approved Supplier List (ASL), including ensuring the creation and maintenance of supporting evidence (Supplier Master File).
• Conduct and oversee supplier audits-qualification and re-qualification, including finding closure; Collect, trend and report supplier quality metrics
• Improve/develop quality systems at selected suppliers for QMS and compliance improvement
• Develop purchasing controls processes, procedures and systems, including those for BOM, non-BOM, services, spare parts and Third Party Finished Goods
• Evaluate and improve the effectiveness of purchasing controls and supplier quality processes and procedures, including Quality Agreements
• Assist in preparing for and defending Purchasing Controls in inspections by external agencies or internal Baxter audits of Purchasing Controls processes; Manage and oversee Purchasing controls CAPA, including root cause identification, and effective and timely closure
• Develop and/or deliver training to internal teams and suppliers.
• Execute SCAR management, effective and timely closure and Review/risk assessment of Supplier Quality Notifications and their escalation to SCARs and NCR where needed
• Accountable for NCR as assigned, conducting NCR timeliness and effectiveness reviews, and trending for corrective/preventive actions,
• Coordinate duties and responsibilities of acquisition or divestiture with the facility, develop/execute/complete associated protocol and ensure that all requirements have been completed and facility is live or divested in the GSQ TrackWise database
• Support Manufacturing, Regulatory, Quality and Purchasing organization for third party suppliers related activities, as applicable.

What do you bring

• Bachelor's degree in life sciences or engineering
• Requires 5+ years of experience in Quality, Manufacturing, Engineering or related field; cross-industry experience a plus (e.g., automotive, aerospace, combination products, pharmaceuticals)
• Manufacturing/Quality experience is preferred in API, excipients and chemicals. Experience with other commodities relevant to medical devices or pharmaceuticals may also be considered.

• Knowledge of pharmaceutical and/or medical device regulations, e.g., ISO 13485, FDA cGMP, MDR, Eudralex, other global or regional equivalent
• Working knowledge of US and International cGMP for API and Excipients
• Experience in Product/process development and/or supplier quality improvement;
• SQA with technical background, a good knowledge of production/quality development and control methods; CtQ definition, DfSS, SPC, APQP, FMEA, Control Plans, etc.
• Auditing skillsets, up to and including certified SQ lead auditor training; Quality Management System auditing, and where possible, special process auditing skills
• Knowledge of Business Acumen; knowledgeable in current and possible future policies, practices, trends, technology, and information affecting his/her industry, business and organization
• Collaboration and Teamwork: Good communications, facilitation, coordination and team skills
• Project management skills managing multiple issues of moderate to high complexity relatively independently with minimal supervision/instructions
• Ability to manage the Quality relationship with assigned key suppliers/stakeholders
• Competence in supporting on-site/off-site supplier quality development including coordination/management of resources
• Multi-tasking skills in a demanding fast paced environment
• Superior time-management skills
• Attention to details and a passion for quality
• Superior written and oral communications skill sets
• Willingness to travel (up to 30%)

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 and long-term incentive. 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.

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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.

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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.

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