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Quality Engineer II

Req ID:  5203

Working Location: CALIFORNIA, SAN JOSE 

 

Are you looking for a company that cares about people’s lives and health, including yours? At Olympus, we help make people’s lives healthier, safer and more fulfilling, every day. 
 
Let’s inspire healthier lives, together.

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/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-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 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, or training.

Job Requirements

REQUIRED QUALIFICATIONS:

 

* Bachelor’s Degree in Engineering or Scientific Discipline or more than three (3) years of Engineering experience.

 

* Minimum of 3 years, ASQ certification preferred.

 

PREFERRED QUALIFICATIONS:

 

* Communication Skills:  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.

 

* Leadership Skills 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.

We realize work isn’t just a job to you.

It’s a big part of your life, but not the only part. That’s why we offer competitive salaries, a robust 401(k) program, annual bonus program and comprehensive medical benefits, as well as tuition reimbursement, flexible schedules, parental and adoption leave, on-site services and Colleague Affinity Networks — so you can be ready for where life can take you.

 

Olympus requires all new hires to be “fully vaccinated” against COVID-19, as defined by the Centers for Disease Control and Prevention (CDC), on or before their first day of work. Individuals who have been offered employment who have a disability, medical condition, or sincerely-held religious belief that prevents them from being vaccinated against COVID-19 are required to request and be granted a reasonable accommodation prior to their first day of work.

 

Olympus is passionate about the solutions it creates for the medical, life sciences, and industrial equipment industries, as well as cameras and audio products. For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling by helping detect, prevent, and treat disease, furthering scientific research, ensuring public safety, and capturing images of the world.

 

Olympus’ Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce overall costs, and enhance the quality of life for patients. Olympus’ Medical portfolio includes endoscopes, laparoscopes, and video imaging systems, as well as surgical energy devices, system integration solutions, medical services, and a wide range of endotherapy instruments for endoscopic and therapeutic applications. For more information, visit www.olympus-global.com.

 

Olympus…True To You. True To Society. True To LIFE.

 

It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.

 

Posting Notes: || United States (US) || California (US-CA) || San Jose || 


Job Segment: Quality Engineer, Field Service, Manufacturing Engineer, Engineer, CAPA, Engineering, Manufacturing, Management

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