Lead Supplier Quality Engineer - Regulated Biotech

SaniSure; Camarillo (CA); On-site; USD 80,000 - 110,000; Full time

Job summary

SaniSure is seeking a Supplier Quality Engineer to ensure compliance of externally sourced materials in medical device manufacturing. This role will involve leading supplier audits and performance monitoring while collaborating cross-functionally with Supply Chain, R&D, and Operations.

The ideal candidate will have a Bachelor's degree and at least 5 years of quality experience in a regulated industry. Strong knowledge of FDA regulations is essential. Join us at SaniSure and contribute to the development of innovative biopharmaceuticals.

Qualifications

• Minimum 5 years of quality experience in a regulated industry.
• Experience conducting supplier audits independently.
• ASQ Auditor or Lead Auditor certification for ISO 13485 preferred.

Responsibilities

• Ensure externally sourced materials meet regulatory and quality requirements.
• Lead supplier selection, qualification, and compliance audits.
• Establish and maintain supplier performance metrics.

Skills

Quality experience in a regulated industry

Strong knowledge of FDA regulations and ISO standards

Supplier auditing practices

Technical writing and analytical skills

Education

Bachelor’s degree in biological sciences, engineering, or related field

Job description

SaniSure is seeking a Supplier Quality Engineer to ensure compliance of externally sourced materials in medical device manufacturing. This role will involve leading supplier audits and performance monitoring while collaborating cross-functionally with Supply Chain, R&D, and Operations.

The ideal candidate will have a Bachelor's degree and at least 5 years of quality experience in a regulated industry. Strong knowledge of FDA regulations is essential. Join us at SaniSure and contribute to the development of innovative biopharmaceuticals.