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Principal Engineer, Quality

Hillrom
United States, New York, Skaneateles Falls
Nov 01, 2024

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:

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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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.

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