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Principal Quality Assurance Engineer

Req ID:  980

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 Principle Quality Assurance Engineer is responsible for providing Quality Engineering input to support Production Operations and Engineering activities. They develop, establish, and maintain Quality Engineering methodologies systems and practices which meet Olympus customer and regulatory requirements. The Principal Engineer willserve as a technical expert to improve awareness visibility andcommunication on Quality initiatives to support departmental functional site divisional and corporate Quality goals and priorities.When needed, works with Olympus Tokyo representatives/liaisons tor esolve 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.

 

* Establish methods for reducing and controlling process costs.

 

* Address or initiate Engineering Change Notices (ECNs) in a timelymanner to maintain project schedules and/or achieve acceptable levels of compliance.

 

* Apply sound systematic problem solving methodologies to identify prioritize communicate and resolve Quality issues with no guidance required.

 

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

 

* Mentor for technical guidance for identifying and resolving quality issues.

 

* Develop new approaches to solve problems identified during Quality assurance activities.

 

* Communicate significant issues or developments identified during.

 

* Quality assurance activities and provide recommended process improvements to cross-functional teams (CFTs) and management.


* Run reports to analyze Production and Complaint data andidentify any significant trends.

 

* Present information and findings to management and other members of the organization.

 

* Manage calibration and metrology activities needed to support.

 

* Work with the calibration vendor to develop a routine calibration schedule.

 

* Coordinate emergency calibrations and complete Outof Tolerance reports as needed.

 

* Manage the Approved Suppliers List (ASL) and ensure allsuppliers/vendors meet Olympus requirements.

 

* Assess suppliers andperform periodic audits to ensure that they continue to meet Olympus standards.

 

* Support the Quality Management System  by performing periodic product process and internal audits.

 

* Support 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:

 

* Bachelor's Degree in Engineering or Scientific Discipline (or equivalent).

 

* Minimum of 12 years of Engineering or related experience.

 

PREFERRED QUALIFICATIONS:

 

* Masters Degree Preferred.

 

* ASQ certification preferred.

 

* Proficient in Microsoft Office.

 

* Ability to program in MS Excel, MS Access, SAP Business Objects and/or other Database tools preferred.

 

* Working knowledge of Datasweep Adwatch SAP and JDE preferred.

 

* Working Knowledge of Minitab Software preferred.

 

* Working Knowledge of AutoCAD and/or SolidWorks preferred.

 

* Strong working knowledge of ISO 13485 and FDA Regulations.

 

* Skilled in examining and re-designing operations and procedures.

 

* Strong understanding of 5S and other forms of waste in the Production environment.

 

* Strong working knowledge of good manufacturing practices.

 

* Working knowledge of metrology and typical metrology instruments including calipers micrometers snap gages etc.

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 || 

 

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