Manufacturing Quality Engineer - CAPA & Process Improvement

Planet Pharma; Hayward (CA); On-site; USD 99,573,000 - 124,645,000; Full time

Job summary

Planet Pharma in Hayward, CA is seeking a Quality Assurance professional to support management of nonconforming materials, RMA processes, and deviations within a regulated manufacturing environment.

You will develop SAP workflows for RMA/NCM handling and execute RMA usage decisions in line with QMS requirements, ensuring records are accurate and compliant. The role emphasizes risk-based decision making and cross-functional collaboration.

Qualifications

• Bachelor's degree in engineering preferred.
• 0–3+ years QA in a regulated manufacturing environment.
• Experience applying 21 CFR 820 and ISO 13485 to real situations.
• Familiar with CAPA, deviation handling and change control processes.

Responsibilities

• Provide QA support for nonconforming materials (NC), RMAs and deviations to ensure timely manufacturing continuity.
• Develop SAP workflows for RMA and NCM handling.
• Execute usage decisions for RMA per QMS requirements.
• Verify accuracy and compliance of NC and deviation records.
• Plan and execute material containment including holds and system transactions.
• Collaborate cross-functionally to implement process improvements.

Skills

Quality Assurance

CAPA & Investigations

Design Controls

Risk Management

Validation / Change Control

Communication Skills

Education

Bachelor's degree in Engineering

Tools

SAP

Job description

Planet Pharma in Hayward, CA is seeking a Quality Assurance professional to support management of nonconforming materials, RMA processes, and deviations within a regulated manufacturing environment.

You will develop SAP workflows for RMA/NCM handling and execute RMA usage decisions in line with QMS requirements, ensuring records are accurate and compliant. The role emphasizes risk-based decision making and cross-functional collaboration.