Address
Form of workThis 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
This position is responsible for overseeing the Quality Computer Systems Management (CSM) Program at the Hayward facility. This position ensures all computer systems used by site personnel are appropriately evaluated for regulatory and quality risks and are qualified/validated to the appropriate level. This position will also provide Quality software support in new equipment/systems, process improvements, compliance projects, and for manufacturing support.
What you'll be doing
• Design/configure, validate, and implement computer systems for use by Hayward personnel. Contribute to global projects and rollouts when necessary.
• Maintain a master list of all computer system assets for the site with appropriate level of detail (including GAMP category, risk levels, etc.).
• Lead and participate Data Integrity initiatives for the site.
• Assist in dashboarding/reporting when requested by Site Leadership, et al. Develop dashboards for metrics using common data visualization tools (e.g., Tableau, ThinkCell, PowerBI, Excel Pivot Charts, etc.).
• Write, review, analyze and revise Standard Operating Procedures (SOPs), as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc.
• Review and approve validation protocols and reports as they relate to computer systems.
• Lead and assist in Quality System records, including non-conformance (NCR) investigations, corrective and preventive actions (CAPAs), and Change Control.
• Lead continuous improvement projects focused on manufacturing and quality processes.
• Perform gap assessment on quality computer system processes.
• Perform standard engineering assignments which are typically a significant portion of a larger project.
• Monitor and report project costs including capital and cross-functional expenses. Estimate cost affected by design and/or policy changes. With supervisor, recommend capital expenditure and production methods for existing or enhanced products or processes.
• Perform data and statistical analysis.
Participate in multi-site projects in the role of contributor, coordinator, or lead.
What you'll bring
• BS in Engineering or Computer Science or equivalent
• 3 - 5 years in Quality Engineering, or 3-5 Years in an IT-related position and other similar experience where technical expertise in computer systems is a must; preferably in a highly regulated industry. Software Validation experience preferred.
• Experience in POMS, SQL Server Management Studio, Visual Basic Analysis, HTML, C++ etc is preferred.
• Industry experience with applicable medical device (21CFR820, ISO13485, CMDR, MDD) and/or biologics regulations desirable
• Must be very detailed oriented with a high quality of work
• Excellent written and oral communication skills
• Knowledgeable in current Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP)
• Working knowledge of FDA regulations (Part 820, 211), ISO 13485, and other applicable regulations.
• Must be able to provide solutions that reflect understanding of customer needs, regulatory requirements, business objectives, and cost implications.
• Must demonstrate effectiveness in ability to train others, drive results, and meet deadlines.
Proficient in Microsoft Office applications (e.g. Word, Excel, etc)
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 $72,000 - $99,000 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 bonus. 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-KV1
The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.
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.
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
This position is responsible for overseeing the Quality Computer Systems Management (CSM) Program at the Hayward facility. This position ensures all computer systems used by site personnel are appropriately evaluated for regulatory and quality risks and are qualified/validated to the appropriate level. This position will also provide Quality software support in new equipment/systems, process improvements, compliance projects, and for manufacturing support.
What you'll be doing
• Design/configure, validate, and implement computer systems for use by Hayward personnel. Contribute to global projects and rollouts when necessary.
• Maintain a master list of all computer system assets for the site with appropriate level of detail (including GAMP category, risk levels, etc.).
• Lead and participate Data Integrity initiatives for the site.
• Assist in dashboarding/reporting when requested by Site Leadership, et al. Develop dashboards for metrics using common data visualization tools (e.g., Tableau, ThinkCell, PowerBI, Excel Pivot Charts, etc.).
• Write, review, analyze and revise Standard Operating Procedures (SOPs), as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc.
• Review and approve validation protocols and reports as they relate to computer systems.
• Lead and assist in Quality System records, including non-conformance (NCR) investigations, corrective and preventive actions (CAPAs), and Change Control.
• Lead continuous improvement projects focused on manufacturing and quality processes.
• Perform gap assessment on quality computer system processes.
• Perform standard engineering assignments which are typically a significant portion of a larger project.
• Monitor and report project costs including capital and cross-functional expenses. Estimate cost affected by design and/or policy changes. With supervisor, recommend capital expenditure and production methods for existing or enhanced products or processes.
• Perform data and statistical analysis.
Participate in multi-site projects in the role of contributor, coordinator, or lead.
What you'll bring
• BS in Engineering or Computer Science or equivalent
• 3 - 5 years in Quality Engineering, or 3-5 Years in an IT-related position and other similar experience where technical expertise in computer systems is a must; preferably in a highly regulated industry. Software Validation experience preferred.
• Experience in POMS, SQL Server Management Studio, Visual Basic Analysis, HTML, C++ etc is preferred.
• Industry experience with applicable medical device (21CFR820, ISO13485, CMDR, MDD) and/or biologics regulations desirable
• Must be very detailed oriented with a high quality of work
• Excellent written and oral communication skills
• Knowledgeable in current Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP)
• Working knowledge of FDA regulations (Part 820, 211), ISO 13485, and other applicable regulations.
• Must be able to provide solutions that reflect understanding of customer needs, regulatory requirements, business objectives, and cost implications.
• Must demonstrate effectiveness in ability to train others, drive results, and meet deadlines.
Proficient in Microsoft Office applications (e.g. Word, Excel, etc)
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 $72,000 - $99,000 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 bonus. 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-KV1
The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.
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.
