Quality Engineer II: Supply Chain, CAPA & Audit Focus

Olympus Corporation; San Jose (CA); On-site; USD 86,465 - 116,728; Full time

Benefits offered by this job

Base pay with annual bonus

401(k) with company match

Medical, dental, and vision coverage

Paid vacation and sick time

Paid parental leave

Job summary

Olympus Corporation in California, San Jose, is seeking a Quality Engineer II to support Supply Chain quality activities, CAPAs, audit responses, and process improvements. You will develop procedures meeting customer and regulatory requirements and serve as the site Quality representative within Supply Chain.

The role requires a Bachelor's in engineering or science, 3+ years of experience, strong communication and cross-functional collaboration, and proficiency in ISO 13485 and FDA regulations.

Qualifications

• Bachelor’s Degree in Engineering or a Scientific Discipline, or more than three years of Engineering experience.
• Minimum of 3 years of experience in relevant fields.
• Strong written and verbal communication skills.
• Ability to communicate clearly and present information across all levels.
• Strong interpersonal skills and ability to work cross‑functionally.
• Project direction capabilities for engineering and technical teams.
• Working knowledge of probability and statistics.
• Ability to organize, prioritize and schedule work assignments.
• Problem‑solving skills.
• Ability to handle multiple project tasks efficiently.
• Basic understanding of 5S and waste elimination in a production environment.
• Working knowledge of ISO 13485 and FDA Regulations.
• Proficiency in Microsoft Office.

Responsibilities

• Develop and establish documented procedures aligned with customer and regulatory requirements.
• Check and drive improvements for continued adherence to Supply Chain documented requirements.
• Review and approve change control activities as the site Quality lead for Supply Chain.
• Ensure inspections of incoming goods have clear specifications and documentation is maintained.
• Handle Supply Chain NCRs, providing product disposition explanations and coordinating approvals from Quality and Finance. Manage the MRB process.
• Support or lead CAPA activities related to Supply Chain functions.
• Recommend additional Field Service or Endoscopy Support Specialist activity where complaints indicate a need for action, support, or training.

Skills

Communication skills

Cross-functional teamwork

Project direction

Statistics knowledge

MS Office proficiency

Regulatory knowledge

Education

Bachelor’s Degree in Engineering or a Scientific Discipline

Tools

MS Excel

MS Access

SAP Business Objects

SAP

Minitab

Job description

Olympus Corporation in California, San Jose, is seeking a Quality Engineer II to support Supply Chain quality activities, CAPAs, audit responses, and process improvements. You will develop procedures meeting customer and regulatory requirements and serve as the site Quality representative within Supply Chain.

The role requires a Bachelor's in engineering or science, 3+ years of experience, strong communication and cross-functional collaboration, and proficiency in ISO 13485 and FDA regulations.