Quality Assurance Specialist – GMP/Med Devices

Baxter International Inc.; Hayward (CA); On-site; USD 68,000 - 94,000; Full time

Benefits offered by this job

Medical and dental coverage from day 1

ESPP with stock purchase discount

401(k) Retirement Savings Plan with 公司

Paid holidays

Paid time off 20–35 days

Job summary

Baxter International Inc. is seeking a Quality Assurance Specialist to ensure compliance, product quality, and operational excellence within its manufacturing environment.

You will partner with manufacturing and support teams to maintain robust quality systems and drive continuous improvement to deliver safe, high-quality products. The role emphasizes on-floor QA activities, change control, audits, and data-driven improvement using Lean and Six Sigma principles.

Qualifications

• Bachelor’s degree in a scientific/engineering/manufacturing field or equivalent experience.
• Experience in regulated manufacturing (medical device, pharmaceutical, biologics, or healthcare).
• GMP, GDP knowledge and quality system requirements.
• Familiarity with FDA regulations (21 CFR 820/211) and ISO 13485.
• Strong attention to detail and accuracy.
• Ability to prioritize, meet deadlines, and collaborate across functions.
• Proficiency with Microsoft Office applications.

Responsibilities

• Review and release production and finished goods documentation for compliance.
• Conduct on-the-floor QA activities: inspections, verifications, and process monitoring.
• Partner with manufacturing and cross-functional teams to identify risks and resolve issues.
• Maintain and improve quality system processes including change controls and document updates.
• Support audits by preparing documentation and addressing observations.
• Analyze quality metrics to identify process improvements.
• Contribute to continuous improvement using Lean and Six Sigma principles.

Skills

Quality systems knowledge

Regulated manufacturing experience

Attention to detail

Cross-functional collaboration

Documentation review

Education

Bachelor's degree in science/engineering/manufacturing

Tools

Microsoft Office

Job description

Baxter International Inc. is seeking a Quality Assurance Specialist to ensure compliance, product quality, and operational excellence within its manufacturing environment.

You will partner with manufacturing and support teams to maintain robust quality systems and drive continuous improvement to deliver safe, high-quality products. The role emphasizes on-floor QA activities, change control, audits, and data-driven improvement using Lean and Six Sigma principles.