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Quality Assurance Engineer I

Req ID:  2817

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 Assurance Engineer I is responsible for providing Quality Engineering input to support Production, Operations and Engineering activities. Maintains and follows Quality Engineering methodologies, systems, and practices which meet Olympus, customer, and regulatory requirements.  Serves as a Quality representative to improve awareness, visibility and communication on Quality initiatives to support departmental, functional, site, divisional and corporate Quality goals and priorities. When needed, works with Olympus Tokyo representatives/liaisons to resolve Quality related issues. 

Job Duties

* Provide Quality Engineering support on projects to implement new product introduction or alternate repair activities. Train Technicians, Supervisors and other employees on the use of new products or processes.

 

* Perform packaging and equipment validations and other verifications/validations to support new product or new repair introductions.

 

* Provide technical guidance to the Change Control Board; educate members on technical issues associated with assigned projects.

 

* Support continuous improvement measures by providing technical information and reviewing processes as they are revised. 

 

* Address or initiate Engineering Change Orders (COs) in a timely manner to maintain project schedules and/or achieve acceptable levels of compliance.  

 

* Supports problem solving activities to resolve Quality issues.

 

* Support and/or drive corrections and corrective actions to resolve non-conformances (DMNs, NCRs, CAPAs and ADT) with minimal guidance.

 

* Communicate significant issues or developments identified during Quality assurance activities and support process improvements identified by cross-functional teams (CFTs) and management.

 

* Analyze Production and Quality data, and identify any significant trends. 

 

* Manage calibration and metrology activities needed to support Production. Work with the calibration vendor to develop a routine calibration schedule. Coordinate emergency calibrations and complete Out of Tolerance reports as needed. 

 

* Support the Quality Management System (QMS) by performing periodic product, process, and internal audits. Support and participate in external audits as needed.

 

* Work with Operations to resolve material issues.

 

* Work directly with the OEM to resolve Quality problems identified through complaint investigations and/or other sources of Quality data. 

 

* Perform all other related duties as assigned.

Job Requirements

REQUIRED QUALIFICATIONS

 

* Associate's degree with a minimum of 8 years in Medical Device Industry, or Bachelor’s Degree in Engineering or Scientific Discipline (or equivalent) with 0-2 years experience of Engineering or related experience.

 

PREFERRED QUALIFICATIONS

 

Proficient in Microsoft Office.

 

* Working knowledge of Datasweep, Adwatch, SAP and JDE preferred.

 

* Working Knowledge of AutoCAD and/or SolidWorks preferred.

 

* Basic understanding of mathematical concepts such as probability and statistical inference as well as perform basic mathematical calculations.

 

* Effective written and verbal communication skills.

 

* Able to communicate clearly.

 

* Must be able to work effectively cross-functionally.

 

* Ability to organize, prioritize and schedule work assignments with supervision.

 

* Ability to solve practical problems.

 

* Ability to complete project tasks and assignments in a timely manner.

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 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, Manufacturing Engineer, Engineer, QA Engineer, Engineering, Quality

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