Sr. Supervisor Quality Compliance

Baxter•Irvine, CA

21h•Onsite

About The Position

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. Supervise and coordinate the activities of multiple sections or departments within the Quality organization, ensuring product quality and compliance with regulations and Baxter quality policies. Serve as a thought leader, subject matter expert, and coach on various quality systems elements, driving excellence in quality management, including but not limited to Document and Change Control Process, Training, Quality Management Review, Change Review Board, internal, corporate / external audits and regulatory inspections, audit readiness, PROSite Model and Risk Management, projects, etc. Ensure suitability and effectiveness of the Irvine Quality Systems and compliance with applicable domestic and international regulations, directives, and standards.

Requirements

Bachelor’s degree in engineering, Science or related field.
3+ years of Quality, Manufacturing, Engineering or related field which should include 2+ years of NCR/CAPA experience.
1-2 years of supervisory experience.
Experience of coordinating and supporting Document Control, Internal Audit, CAPA and Non-conformance.
Thorough knowledge of applicable procedures, specifications, regulations and standards.
Strong analytical and problem-solving skills.
Ability to manage/supervise a team of employees.
Good interpersonal/communication/influencing/negotiation skills.
Strong command of problem-solving techniques and ability to coach others in their application.
Good project management skills.
Must be able to write clearly and informatively, edit work for spelling and grammar, presents numerical data effectively, able to read and interpret written information.
Good communication skills- able to speak clearly, listen and get clarification, present information to internal audience and regulatory bodies’ auditors.
Working knowledge of FDA quality system regulations

Responsibilities

Oversee the daily operations of a section or department, ensuring product quality, performance, and safety meet regulatory requirements and company standards.
Develop, implement, and maintain quality systems procedures to ensure compliance with regulatory requirements and company standards within the section or department.
Develop, maintain, and update inspection documentation procedures to ensure compliance with product regulations and company standards.
Coordinate site audit-readiness activities, including internal, corporate and external audits and regulatory inspections, to ensure compliance and assess risk within the organization.
Coordinate and facilitate site inspections by regulatory agencies and Notified Bodies and serve as the primary point of contact during inspections.
Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; address any issues or concerns that may arise.
Identify opportunities for process improvements and implement changes to enhance efficiency, productivity, and quality within the organization.
Collaborate with the Quality organizations and site to achieve business targets and meet key performance indicators (KPIs).

Benefits

comprehensive compensation and benefits packages for eligible roles
medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
educational assistance programs
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
paid parental leave
commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)
childcare benefits