Principal Engineer, Quality

Posted 5 Days Ago
Be an Early Applicant
Skaneateles, NY
104K-143K Annually
Senior level
Healthtech • Other
The Role
As a Principal Engineer in Quality at Baxter, you will ensure compliance and provide quality guidance, evaluate regulatory risks, conduct investigations, support supplier improvement projects, analyze quality data, and collaborate with engineering and procurement teams to maintain quality standards.
Summary Generated by Built In

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.

#LI-LS1

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.

The Company
HQ: Deerfield, IL
35,858 Employees
On-site Workplace
Year Founded: 1931

What We Do

Every day, millions of patients, caregivers and providers around the world rely on Baxter’s leading portfolio of diagnostic, critical care, nutrition, kidney care, hospital and surgical products and solutions. For 90 years, we’ve been making an impact at the critical intersection where innovations that save and sustain lives meet the healthcare providers who make it happen. With products, therapies and digital health solutions available in more than 100 countries, Baxter’s employees worldwide are now building upon the company’s rich heritage of medical breakthroughs to advance the next generation of transformative healthcare innovations.

We welcome Hillrom to Baxter, where we are uniting to advance patient care worldwide. We’re building on the strengths of two historically innovative and socially responsible companies that will better serve our patients, customers and communities.

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