Working Location: California, San Jose

Workplace Flexibility: Onsite

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 Serviceand Asset Management to where additional training/assistance 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.
• Recommends 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 expeerience.
• Must have strong written and verbal communication skills.
• Must be able to communicate clearly and present information concepts and ideas across all levels of the organization.
• Must have strong interpersonal skills and be able to work effectively cross-functionally.
• Provides project direction for engineering and technical teams.
• 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.
• Ability to work on multiple project tasks and assignments efficiently.
• 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 and/or other Database tools preferred.
• SAP preferred.
• Working Knowledge of Minitab Software preferred.

Why join Olympus?

We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.

Equitable Offerings you can count on:

• Competitive salaries, annual bonus and 401(k)* with company match
• Comprehensive medical, dental, vision coverage effective on start date
• 24/7 Employee Assistance Program
• Free live and on-demand Wellbeing Programs
• Generous Paid Vacation and Sick Time
• Paid Parental Leave and Adoption Assistance*
• 12 Paid Holidays
• On-Site Child Daycare, Café, Fitness Center**

Connected Culture you can embrace:

• Work-life integrated culture that supports an employee centric mindset
• Offers onsite, hybrid and field work environments
• Paid volunteering and charitable donation/match programs
• Employee Resource Groups
• Dedicated Training Resources and Learning & Development Programs
• Paid Educational Assistance

*US Only

**Center Valley, PA and Westborough, MA

Are you ready to be a part of our team?

Learn more about our benefits and incentives: https://www.olympusamerica.com/careers/benefits-perks.

The anticipated base pay range for this full-time position in this location is $86,465.00 - $116,728.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements).

Olympus considers a variety of factors when determining actual compensation for this position, including level of experience, working location, and relevant education and certifications.

Posting Notes: || United States (US) || California (US-CA) || San Jose || Quality & Regulatory Affairs (QA/RA)