Supplier Quality & Compliance Engineer

Katalyst Healthcares & Life Sciences; Sunnyvale (CA); On-site; USD 70,000 - 100,000; Full time

Job summary

Katalyst Healthcares & Life Sciences is seeking a Supplier Quality Engineer in Sunnyvale, California. This role involves evaluating and managing suppliers to ensure compliance with rigorous standards in medical device production.

The ideal candidate will have a BS degree in Engineering, with extensive project management and problem-solving skills. Strong knowledge of regulatory standards such as ISO 13485 is essential. The company offers opportunities for professional growth.

Qualifications

• BS degree in Engineering or equivalent, master's preferred.
• Excellent knowledge of 21 CFR part 820 and ISO 13485.
• Ability to communicate technical information effectively.

Responsibilities

• Evaluate suppliers and conduct on-site assessments.
• Lead supplier improvement initiatives and resolve quality issues.
• Develop and monitor supplier performance metrics.

Skills

Excellent problem solving skills

Project management

Excellent written and verbal communication

Practical knowledge of PFMEA's

Ability to read technical drawings

Experience in Lean/6 Sigma/SPC programs

Strong computer skills (Windows, Word, Excel, Access)

Education

BS degree in Engineering

Master's degree preferred

Tools

SAP

3D modelling tools

Job description

Katalyst Healthcares & Life Sciences is seeking a Supplier Quality Engineer in Sunnyvale, California. This role involves evaluating and managing suppliers to ensure compliance with rigorous standards in medical device production.

The ideal candidate will have a BS degree in Engineering, with extensive project management and problem-solving skills. Strong knowledge of regulatory standards such as ISO 13485 is essential. The company offers opportunities for professional growth.