Senior Quality Engineer: Supply Chain & CAPA Leader

Olympus Corporation of the Americas; 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

Medical, dental, vision coverage

Job summary

Olympus Corporation of the Americas seeks a Quality Engineer II to provide quality engineering input supporting Supply Chain, CAPAs, audits, and engineering activities. The role develops documented procedures to meet customer and regulatory requirements and acts as site Quality representative to improve awareness and communication on quality initiatives.

Responsibilities include approving change controls, managing incoming inspections, resolving NCRs and MRB processes, and leading CAPA

Qualifications

• Bachelor’s Degree in Engineering or Scientific Discipline or more than three years of Engineering experience.
• Minimum of 3 years of experience in engineering.
• Strong written and verbal communication skills.
• Ability to communicate clearly across all levels of the organization.
• Interpersonal skills to work effectively cross-functionally.
• Project direction for engineering teams.
• Mathematical concepts such as probability and statistics.
• Organize prioritize and schedule work assignments with some supervision.
• Able to solve practical problems.
• Ability to handle multiple project tasks efficiently.
• Basic understanding of 5S and waste elimination in Production.
• Working knowledge of ISO 13485 and FDA Regulations.
• Proficient in Microsoft Office.

Responsibilities

• Develop and establish procedures meeting customer and regulatory requirements.
• Drive improvements for adherence to Supply Chain requirements.
• Review and approve change control as site Quality lead for Supply Chain.
• Ensure clear specifications for incoming goods and documentation of inspections.
• Handle NCRs with disposition approvals and MRB management.
• Support or lead CAPA activities related to Supply Chain.
• Recommend Field Service or Endoscopy support actions when needed.

Skills

Communication skills

Cross-functional collaboration

Analytical thinking

Project leadership

Statistical knowledge

Prioritization & scheduling

Problem solving

Multitasking

5S knowledge

Regulatory knowledge ISO 13485 FDA

MS Office

Education

Bachelor’s Degree in Engineering or Scientific Discipline

Tools

MS Excel

MS Access

SAP

SAP Business Objects

Minitab

Job description

Olympus Corporation of the Americas seeks a Quality Engineer II to provide quality engineering input supporting Supply Chain, CAPAs, audits, and engineering activities. The role develops documented procedures to meet customer and regulatory requirements and acts as site Quality representative to improve awareness and communication on quality initiatives.

Responsibilities include approving change controls, managing incoming inspections, resolving NCRs and MRB processes, and leading CAPA