Supplier Quality Assurance Lead (Injection Molding Expert)

This is whereyour work makes a difference.

At Baxter we believe every personregardless of who they are or where they are fromdeserves 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 jobyou 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 Baxters 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 supplier performance review supplier audits and supplier quality development.

What you will be doing

Supplier Development:

• Improve/develop quality systems at selected suppliers for QMS and product quality improvement
• Execute SCAR management effective and timely closure and review/risk assessment of supplier quality notifications and their escalation to SCARs and NCR where needed
• Collect trend and report supplier performance metrics
• Manage and oversee Supplier CAPA including root cause identification and effective and timely closure
• Develop and/or deliver training and process improvement to internal teams and suppliers.

Supplier Qualification / Maintenance:

• Perform qualification of component and medical device combination device suppliers.
• Conduct and oversee supplier audits-qualification and re-qualification including finding closure.
• Evaluate and improve the effectiveness of purchasing controls and supplier quality processes and procedures.
• Assist in preparing for and defending Purchasing Controls in inspections by external agencies or internal Baxter audits of Purchasing Controls processes.
• 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

• Bachelors 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. Experience with other commodities relevant to medical devices or pharmaceuticals may also be considered.
• Experience in root cause analysis corrective and preventive action methods; Expertise/experience in problem solving with quality tools such as: 6-sigma / 8-D / CAPA / FMEA / 5WHY etc.
• Experience with data analysis and reporting using basic Excel toolkit and advanced statistical /process packages such as Minitab or Visio and PowerPoint
• Knowledge of medical device regulations e.g. ISO 13485 FDA cGMP other global or regional equivalent
• Working knowledge of US and International cGMP
• Experience in Product/process development and/or supplier quality improvement
• Injection molding and device manufacturing
• 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
• 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
• Willingness to travel within North and South America (up to 40%)

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 $112000 - $154000 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 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.

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