Senior Quality Leader — Plant Operations

Baxter Healthcare; Hayward (CA); On-site; USD 160,000 - 220,000; Full time

Benefits offered by this job

Medical and dental coverage from day 1

ESPP (Employee Stock Purchase Plan)

401(k) Retirement Savings Plan with 2:

Paid time off 20-35 days

Parental leave

Employee discounts

Job summary

Baxter Healthcare in Hayward, CA is seeking a Senior Quality Executive to lead plant-level quality management and deploy the quality system across the site. You will ensure regulatory compliance, drive CAPA and design controls, and oversee cross-functional teams to sustain product quality and process improvements.

The role requires extensive GMP knowledge, strategic leadership, and collaboration with global teams. Competitive compensation, and eligibility for discretionary bonuses are noted.

Qualifications

• Bachelor's degree required in Science, Engineering or related field.
• Minimum of 10 years in Quality, Manufacturing or related field in medical products.
• Minimum of 7 years of management experience.

Responsibilities

• Serve as the Management Representative for Quality and lead the Quality organization within a mid-to-large manufacturing facility.
• Build and develop a high-performing Quality organization aligned with business growth and global expansion.
• Oversee batch review and product release activities.
• Fulfill PRRC responsibilities and ensure device conformity per MDR before release.
• Ensure Post-Market Surveillance obligations are fulfilled.
• Direct large-scale programs and drive divisional and corporate quality initiatives.
• Manage regulatory inspections and audits and comply with quality policies.

Skills

Regulatory knowledge

Leadership

Cross-functional collaboration

Analytical skills

Communication

Education

Bachelor's degree in Science/Engineering

Advanced degree preferred

Job description

Baxter Healthcare in Hayward, CA is seeking a Senior Quality Executive to lead plant-level quality management and deploy the quality system across the site. You will ensure regulatory compliance, drive CAPA and design controls, and oversee cross-functional teams to sustain product quality and process improvements.

The role requires extensive GMP knowledge, strategic leadership, and collaboration with global teams. Competitive compensation, and eligibility for discretionary bonuses are noted.