Quality Engineer II

Job Description

The Quality Engineer II is responsible for providing Quality Engineering input to support Supply Chain with improvements, projects (including CAPAs and audit responses), and Engineering activities.

Further develops or establishes documented procedures which meet Olympus customer and regulatory requirements.

Serves as the site Quality representative within Supply Chain to improve awareness, visibility, and communication on Quality initiatives. This position supports departmental, functional, site, divisional, and corporate Quality goals and priorities. When needed, works with Olympus Tokyo representatives/liaisons to resolve Quality-related issues. Responsible for quality-related inventory management and disposition of quality hold material. Shares complaint and repair data to alert Field Service and Asset Management to where additional training/support may be required.

Job Duties

• Develop and establish documented procedures which meet Olympus customer and regulatory requirements and align well with other related processes and systems (e.g., WMI-Data sweep system interactions and associated process documentation).
• 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 the inspection of incoming goods has clear specifications and that the documentation of incoming inspections is maintained and easily accessible when needed.
• Handle Supply Chain NCRs, with clear explanation of product disposition with approvals from Quality and Finance (when applicable). Manage the MRB process.
• Support or Lead CAPA activities related to Supply Chain functions whether direct or indirect.
• Recommend additional Field Service or Endoscopy Support Specialist activity where complaints show a need for action, support, training.

Job Qualifications

• Required:
• Bachelor’s Degree in Engineering or Scientific Discipline or more than three (3) years of Engineering experience.
• Minimum of 3 years of experience.
• Strong written and verbal communication skills.
• Strong interpersonal skills and ability to work effectively cross-functionally.
• Ability to work with mathematical concepts such as probability and statistics.
• Ability to organize, prioritize, and schedule work assignments with some supervision.
• Ability to solve practical problems.
• Basic understanding of 5S and other forms of waste elimination in the Production environment.
• Working knowledge of ISO 13485 and FDA Regulations.
• Proficient in Microsoft Office.
• PREFERRED:
• ASQ certification preferred.
• Ability to program in MS Excel, MS Access, SAP Business Objects, or other Database tools preferred.
• SAP preferred.
• Working Knowledge of Minitab Software preferred.