Manager, Quality Assurance

Baxter International Inc. • Winton, CA

15d • $112,000 - $154,000 • Onsite

About The Position

As the Quality Assurance Manager at Baxter you will be responsible for Day-to-day activities of Quality Operations, Quality Assurance, including Inspections/ Batch Release, Compliant Investigations and management oversight of NCRs/ CAPA’s. You will also ensure cGMP compliance and Inspection readiness by ensuring quality and compliance are built into day-to-day operations.

Requirements

• BS in science or engineering preferred with 5+ years’ experience in Quality, Manufacturing, Engineering, or related field which should include 1-2 years of supervisory experience in a Medical Device or Pharma Industry.
• Thorough knowledge of applicable procedures, specifications, regulations, and standards.
• Strong leadership skills and demonstrated success in managing mid to large teams. Capable of managing in matrix and ability to interact successfully with multi-functions globally
• Strong analytical and problem-solving skills.
• Ability to manage/supervise a team of employees.
• Good communication and leadership skills.
• Good interpersonal/communication/influencing/negotiation skills.
• Good project management skills.
• Good solid understanding of applicable quality and regulatory standards and regulations
• Comfortable and capable of gowning into an ISO 7/ISO 8 manufacturing environment
• 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.

Nice To Haves

• May perform other duties as assigned

Responsibilities

• Implementation and improvement of Quality Processes that will assure compliance with Regulations, Corporate and Local procedures, and specifications.
• Quality Representative in the manufacturing areas.
• Manage the batch review and release activities.
• Interfaces with regulators during regulatory inspections/ audits.
• Identifies, manages and drives continuous Improvement and MIP projects with the objective of achieving quality, reliability, and cost Improvements.
• Ensure adherence to budget.
• Support change control activities for manufacturing operations.
• Manage the release process, inspection, and batch release activities.
• Oversee, initiate, investigate and approve non-conformance report activities as needed.
• Promote a zero-harm workplace and assure that required EHS resources are available and that all applicable EHS practices and rules are being followed by supervised employees.
• Responsible for adherence to specifications and procedures that have been established to ensure product quality in area of responsibility.
• Interacts frequently with all levels of internal management as well as across functions and franchises.
• Manages overall coaching, training, development and succession plans for the team.

Benefits

• 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
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Manager