Supervisor I, Quality Systems
Company: BAXTER
Location: Moraga
Posted on: August 7, 2022
Job Description:
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. SummaryThis role
supports the Quality Systems Manager on meeting key quality
deliverables. This position is responsible for direct oversight of
functional teams including Document Control, Training, and Batch
Release. Additional responsibilities include driving Change Control
System and involving the customer complaints management system to
ensure products and services are provided per customer
requirements. Manage multiple projects and provide support for
other Quality Systems such as NCR/CAPA, Complaints, and Quality
Audits. Must be able to work with Product / Process development
teams, Manufacturing, and support groups at all levels. The
position requires interaction with corporate and other Baxter sites
and requires a solid understanding of Quality system elements.
Preferred to have strong understanding of medical Device
regulations as it relates to document control, training, batch
release, quality audits, complaints, MDR, Adverse events and change
control.Essential Functions
- Review change control projects and provide the quality
approvals for them.
- Share the change control metrics with the departments
- Provide metrics for Document Control, Training, and Batch
Release teams
- Organize follow up meetings with change control project owners
and department managers
- Coordinate CCB meeting and generate meeting minute notes.
- Perform impact assessment when needed
- Conduct in-depth complaint investigations
- Approve the complaint evaluation conclusion documents
- Participate in compliance risk evaluation meetings and
distribute the meeting notes
- Provide oversight and support of batch release process
- Implements or maintains quality systems procedures and
standards
- Understands and assures conformance to regulations and company
procedures
- Supports internal and external audits
- Identifies and manages continuous improvement projects with the
objective of achieving quality, reliability, and cost improvements.
- May initiate nonconformance reports, and be involved in the
investigation
- Responsible for coaching, training, and development of junior
level employees in change control and as a master trainer
- May work in special projects/teams May perform other duties as
assigned.Qualifications
- Good understanding of medical device regulations, supervisory
and project management skills, knowledge or experience in document
control, training, batch release, change control, risk management,
NCR/CAPA, and complaint investigations
- Strong analytical and problem-solving skills
- Leading/supporting the other departments and /or teams
- Good communication and leadership skillsEducation
- BS in relevant Science or engineering and 8 years of experience
in GMP
- Supervisory or group/team leader experience 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 OpportunityBaxter 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 . 067133
Keywords: BAXTER, San Francisco , Supervisor I, Quality Systems, Other , Moraga, California
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