Senior Quality Engineer

Olympus Corporation of the Americas•Brooklyn Park, MN

19h•Onsite

About The Position

The Senior Quality Engineer is responsible for providing Quality Engineering leadership 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. Leads QE functions within Supply Chain across multiple sites to improve awareness visibility and communication on Quality initiatives. 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/assistance may be required. Supports and provides guidance to Quality Engineers and Engineers across Olympus.

Requirements

Bachelor’s Degree in Engineering or Scientific Discipline or more than five (5) years of Engineering experience.
Minimum of 5 years experience.
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.

Nice To Haves

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.

Responsibilities

Develop and establish documented procedures which meet Olympus customer and regulatory requirements and align well with other related processes and systems (e.g. WMI-Datasweep 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 multi-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 across multiple sites.
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, or training.