Job description

Experience leading all aspects of FUE and CSV activities in an FDA-regulated environment, ensuring compliance with cGMP, 21 CFR Part 11, and ISO 13485 requirements is required.

Job Description:-

Please note that at this time we are unable to sponsor employment authorization (both new and transfer). The position is not eligible for relocation.

Requirements:-

7-10 years of experience in FUE (Facilities, Utilities, Equipment), CSV, Automation, and QC systems

Developing, reviewing, and implementing Supplier Assessment Plans (SAP) and Master Validation Plans (MVP) for facilities, utilities, equipment, and computerized systems

Experience in supporting the manufacturing of medical devices is required

Responsibilities:-

Develop, review, and approve FUE and CSV protocols and validation reports

Ensure compliance with cGMP and Change Control related FUE, CSV, and software systems

Provide leadership and direction on software quality implementation processes

Review and approve changes to existing systems

Ensure Good Documentation Practices (GDP) compliance and control test discrepancies

Author Standard Operating Procedures (SOPs) as required

Lead investigations and deviations related to validation activities

Support audits, non-conforming events, and CAPAs

Job Type: Full-time

Pay: Up to $80.00 per hour

Experience level:

• 7 years

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Work setting:

• Hybrid remote

Ability to commute/relocate:

• South San Francisco, CA 94080: Reliably commute or planning to relocate before starting work (Required)

Work Location: Hybrid remote in South San Francisco, CA 94080

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