Principal Quality Assurance Engineer
Company: Olympus Corporation of the Americas
Location: San Jose
Posted on: February 22, 2021
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Job Description:
*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 -- #Recruit
Keywords: Olympus Corporation of the Americas, San Jose , Principal Quality Assurance Engineer, Engineering , San Jose, California
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