Quality Engineer II

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

Quality Engineer II

Location: California, San Jose

Job Summary

The Quality Engineer II provides Quality Engineering input to support Supply Chain with improvements, projects (including CAPAs and audit responses), and engineering activities. They develop or establish documented procedures that meet customer and regulatory requirements, serve as the site Quality representative within Supply Chain, and support departmental functional site divisional and corporate Quality goals and priorities.

Key Responsibilities

• Develop and establish documented procedures aligned with customer and regulatory requirements and related processes.
• 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 and accessible.
• 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.

Required Qualifications

• Bachelor’s Degree in Engineering or a Scientific Discipline, or more than three (3) 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.

Preferred Qualifications

• ASQ certification.
• Programming or advanced proficiency in MS Excel, MS Access, SAP Business Objects, or other database tools.
• SAP experience.
• Working knowledge of Minitab.

Benefits

The anticipated base pay range for this full‑time position in this location is $86,465.00 – $116,728.00 per year, plus potential for an annual bonus. Olympus provides competitive salaries, annual bonuses, 401(k) with company match, comprehensive medical, dental, and vision coverage effective on the start date, paid vacation and sick time, paid parental leave, and a variety of wellness and professional development programs.

Equal Employment Opportunity Statement

We are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a non‑discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage all who wish to bring their talents to Olympus to apply. Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact [e-mail].