Principal Engineer, Quality

Responsible for compliance, validation and providing Quality guidance for process/area responsibilities. Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Baxter quality practices. Leads and conducts root cause investigations for multi-group projects in the development of continuous improvement and corrective / preventative action philosophies and strategies.

Your Team at Baxter:

Within Quality Ops, 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 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.

We form relationships with each other to get work done. Building these relationships is easy because we all share common traits of being reliable, ethical, and caring. We lean on our colleagues for their expertise and hold each other accountable. We feel empowered to speak up when there's a new insight or opportunity to improve something. This open dialog builds trust within the team and helps create a better product for our customers.

What You’ll Be Doing:

• Support supplier improvement projects to meet deadlines and document results for closure.

• Perform supplier related investigation activities and implement corrective actions for the site across several commodities and suppliers.

• Assist in analysis of data from various quality inputs (may include but no limited to: Field Actions, Complaints, Non-conformance reports, DPPM) to determine trends and systemic issues.

• Apply operating practices and problem-solving methodology to perform root cause investigation analysis. Document actions within appropriate quality system (NCR, CAPA, SCAR).

• Participate product complaint trending meetings for responsible areas. Analyze returned components, recommend corrective actions, and follow-up on cross-functional team responses and implementation of corrective actions.

• Escalate supplier related issues to principal engineers and manager for assistance to implement mitigation actions and address non-conformities as needed.

• Collaborate with internal engineering and procurement teams to create qualification plans and complete qualification reports for new components or component changes.

• Assist in supplier qualification process (including but not limited to: risk review, document review, audits) to ensure that suppliers meet quality requirements and can provide compliant material and/or services.

• Work with internal engineering, quality, and receiving inspection teams to create and maintain inspection plans. Support receiving inspection team review material and clarify requirements per specifications as needed.

What You’ll Bring:

• Minimum of a Bachelors Degree in Engineering with a minimum of 7+ years related experience, or 4+ years related experience with an advanced degree or proven performance and increasing responsibility within Quality roles.

• Ability to work optimally with multi-department and multi-site teams

• Ability to lead and organize sophisticated technical problems

• Good written and oral communication skills, excellent attention to details

• Strong team leader with leadership skills and focus on results

• Strong scientific analysis and troubleshooting skills

• Knowledge of GMP/manufacturing environment and regulatory compliance for the manufacturing of bulk and finished products and current industry standards related to sterilization, cleaning and other validation processes

• Must have the ability to manage people, encourage teamwork and drive decisions.

• Six Sigma black belt or ASQ CQE certification highly desirable.

• Prior experience interacting with the FDA and other regulated industries is a must.

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 $104,000 - $143,000 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, commission, and/or 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.

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