Senior Quality Director - Medical Devices & Compliance

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

Job summary

Baxter International Inc. in Hayward, CA, seeks a Most Senior plant-level Quality Management Representative to develop and deploy the plant's quality system and ensure regulatory compliance before product release.

You will lead the Quality organization, oversee batch review and product release, and drive CAPA, Design Controls, and Post-Market Surveillance while partnering with global teams to meet business objectives.

Qualifications

• Bachelor's degree in science, engineering, or related technical discipline.
• 10+ years in Quality, Manufacturing, or related field within medical products.
• 7+ years of management experience in a regulated environment.
• Experience with regulatory compliance and medical device standards.
• Ability to work in ISO 7/ISO 8 cleanroom environments.

Responsibilities

• Serve as the Management Representative for Quality and lead the Quality organization within a large manufacturing facility.
• Build and develop a high-performing Quality team with a clear vision and mission.
• Oversee batch review and product release activities.
• Fulfill the responsibilities of PRRC and ensure conformity before release.
• Ensure Post-Market Surveillance obligations are fulfilled.
• Drive continuous improvement across processes and systems.
• Collaborate with stakeholders across functions and global locations.
• Serve as primary quality representative with customers and regulators.

Skills

Regulatory compliance

Leadership

Quality systems

CAPA

GMP

Data analysis

Cross-functional

Education

Bachelor's degree

Advanced degree preferred

Tools

QMS (Quality Management System)

Regulatory inspections

Job description

Baxter International Inc. in Hayward, CA, seeks a Most Senior plant-level Quality Management Representative to develop and deploy the plant's quality system and ensure regulatory compliance before product release.

You will lead the Quality organization, oversee batch review and product release, and drive CAPA, Design Controls, and Post-Market Surveillance while partnering with global teams to meet business objectives.