Quality Engineer II - Hybrid, CAPA & Quality Lead

Olympus America, Inc.; San Jose (CA); On-site; USD 86,000 - 117,000; Full time

Benefits offered by this job

Competitive salary+annual bonus

401(k) with company match

Employee assistance program

Paid vacation and holidays

On-site daycare/cafe/gym

Job summary

Olympus America, Inc. seeks a Quality Engineer II to support Supply Chain with quality improvements, CAPAs, audits, and engineering activities. You will develop procedures, manage quality disposition, and lead CAPA projects while collaborating across functions and with international teams.

The role requires 3+ years in engineering and strong communication, with knowledge of ISO 13485 and FDA regulations. Olympus offers competitive pay, bonuses, PTO, and comprehensive benefits, with on-site

Qualifications

• Bachelor’s Degree in Engineering or a scientific discipline or more than three years of engineering experience.
• Minimum 3 years of engineering experience and strong written and verbal communication skills.
• Ability to communicate clearly across all levels of the organization and work cross-functionally.
• Experience guiding engineering/technical teams and handling statistics or probability concepts.
• Familiar with ISO 13485 and FDA Regulations; 5S/waste elimination knowledge is a plus.
• Proficiency with MS Office; SAP/BI tools preferred.

Responsibilities

• Develop and establish procedures meeting customer and regulatory requirements.
• Drive improvements for supply chain documented requirements and product disposition.
• Review and approve change controls as site Quality lead for Supply Chain.
• Ensure incoming goods inspections have clear specs and accessible documentation.
• Handle NCRs and MRB processes with cross-functional approvals.
• Lead CAPA activities related to Supply Chain functions.
• Recommend Field Service actions based on complaints and training needs.

Skills

Communication

Cross-functional work

Problem solving

Project leadership

Maths/Statistics

Prioritization

ISO 13485 knowledge

Education

Bachelor’s Degree in Engineering or Scientific Discipline

ASQ certification (preferred)

Tools

MS Office

MS Excel

MS Access

SAP

Minitab

SAP Business Objects

Job description

Olympus America, Inc. seeks a Quality Engineer II to support Supply Chain with quality improvements, CAPAs, audits, and engineering activities. You will develop procedures, manage quality disposition, and lead CAPA projects while collaborating across functions and with international teams.

The role requires 3+ years in engineering and strong communication, with knowledge of ISO 13485 and FDA regulations. Olympus offers competitive pay, bonuses, PTO, and comprehensive benefits, with on-site