Senior Design Quality Specialist
$88k - $121kBaxter
This is where your 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 This position is for the Design Quality Specialist supporting the Baxter Clinical Nutrition Medical Device disposables product platform. Provides design quality support to the sustaining product development team to ensure compliance of the required DHF deliverables, resulting in the development of safe and effective medical devices.
What you will be doing
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. #LI-RS1 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. 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. 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.
Your role at Baxter This position is for the Design Quality Specialist supporting the Baxter Clinical Nutrition Medical Device disposables product platform. Provides design quality support to the sustaining product development team to ensure compliance of the required DHF deliverables, resulting in the development of safe and effective medical devices.
What you will be doing
- As Quality Reviewer performs document reviews to support design and labeling change controls.
- Collaborate with teams to provide mentorship for meeting Baxter QMS Requirements and External Quality Standards as appropriate.
- Conducts complaint trend analysis and analyzes data from various sources (Non-Conformances, Field Corrective Actions, and Complaints) to drive decisions.
- Facilitates small project teams as needed to accomplish team objectives.
- Supports Quality internal and external audits as the need arises.
- Applies DMAIC tools to investigate non-conformances and participates in (CAPA) related activities, including CAPA ownership.
- Bachelor's degree in Engineering, Science, or a related technical discipline.
- 3-5 years related engineering/science/quality experience.
- Preferred: Prior experience in product development, design and/or testing within medical device industry
- Ability to travel up to approximately 10% as needed,
- Solid understanding of FDA Regulations, Design Controls and Change Control requirements.
- Display a technical understanding of engineering and product development principles and procedures.
- Possess basic understanding of DMAIC investigation tools.
- Familiarity with Minitab required.
- Experience in working with cross-functional teams, including technical and non-technical work.
- Ability to organize and present technical information with minimal assistance.
- Demonstrates solid organizational skills and ability to work independently.
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. #LI-RS1 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. 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. 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.
Vacancy posted 4 days ago
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