Senior Supplier Quality Engineer II — Global Assurance

Planet Pharma; Aliso Viejo (CA); Vor Ort; USD 107.000 - 134.000; Vollzeit

Zusammenfassung

Planet Pharma in California is seeking a Senior Supplier Quality Engineer II to oversee supplier qualification, audits, and performance to ensure regulatory and quality requirements for medical devices and pharmaceuticals are met. You will lead supplier assessments, on-site inspections, and drive corrective actions to improve supplier quality and on-time delivery.

The role requires 8+ years of experience, deep knowledge of 21 CFR, ISO standards, and ASQ certifications (CQA, CQE, CSSBB).

Qualifikationen

• 8+ years of relevant experience in supplier quality or QA.
• Deep knowledge of 21 CFR 210, 211, Annex 1, 21 CFR Part 820, ISO 13845 and ISO 14971.
• ASQ certifications preferred (CQA, CQE, CSSBB)
• Strong documentation, communication, and teamwork skills

Aufgaben

• Review requests for new suppliers to determine risk level and qualification requirements.
• Classify risk level and determine supplier qualification needs.
• Maintain Approved Suppliers List (ASL) information in Oracle.
• Lead supplier assessments and on-site audits.
• Drive Supplier Corrective Action Requests (SCARs) and continuous improvement.
• Develop and maintain supplier quality documentation and processes.
• Engage cross-functionally with product teams and suppliers to meet quality standards.
• Travel up to 50% to visit suppliers as needed.

Kenntnisse

Supplier quality

Audits

Regulatory compliance

QA systems

Ausbildung

Bachelor’s degree in Engineering

Tools

Oracle

QMS

Jobbeschreibung

Planet Pharma in California is seeking a Senior Supplier Quality Engineer II to oversee supplier qualification, audits, and performance to ensure regulatory and quality requirements for medical devices and pharmaceuticals are met. You will lead supplier assessments, on-site inspections, and drive corrective actions to improve supplier quality and on-time delivery.

The role requires 8+ years of experience, deep knowledge of 21 CFR, ISO standards, and ASQ certifications (CQA, CQE, CSSBB).