Quality Assurance Engineer II at Olympus Corporation of the Americas in San Jose, CA
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 II is responsible for providing Quality Engineering input to support Production Operations and Engineering activities. They develop establishes and maintains Quality Engineering methodologies systems and practices which meet Olympus customer and regulatory requirements. The position 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, they work 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. With guidance can establish methods for reducing and controlling process costs. Address or initiate Engineering Change Notices (ECNs) in a timely manner 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 some guidance. Support and/or drive corrections and corrective actions to resolve non-conformances (DMNs NCRs CAPAs) 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. Coordinate emergency calibrations and complete Out of Tolerance reports as needed. Use and maintain the Approved Suppliers List (ASL) and support activities that ensure all suppliers/vendors meet Olympus requirements. Assess suppliers to ensure that they continue to meet Olympus standards. Support the Quality Management System (QMS) by performing periodic product process and internal audits. Perform all other related duties as assigned. Job Requirements REQUIRED
Qualifications:
Bachelor's Degree in Engineering or Scientific Discipline or a minimum of 3-5 years of Engineering 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. PREFERRED
Qualifications:
ASQ certification preferred. Ability to work with mathematical concepts such as probability and statistical inference as well as perform basic mathematical calculations. Working knowledge of Datasweep, Adwatch, SAP, and JDE preferred. Working Knowledge of Minitab Software preferred. Working Knowledge of AutoCAD and/or SolidWorks preferred. Working knowledge of ISO 13485 and FDA Regulations Previous experience in examining and re-designing operations and procedures.
Salary Range:
$80K -- $100K
Minimum Qualification
Quality AssuranceEstimated Salary: $20 to $28 per hour based on qualifications.
Qualifications:
Bachelor's Degree in Engineering or Scientific Discipline or a minimum of 3-5 years of Engineering 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. PREFERRED
Qualifications:
ASQ certification preferred. Ability to work with mathematical concepts such as probability and statistical inference as well as perform basic mathematical calculations. Working knowledge of Datasweep, Adwatch, SAP, and JDE preferred. Working Knowledge of Minitab Software preferred. Working Knowledge of AutoCAD and/or SolidWorks preferred. Working knowledge of ISO 13485 and FDA Regulations Previous experience in examining and re-designing operations and procedures.
Salary Range:
$80K -- $100K
Minimum Qualification
Quality AssuranceEstimated Salary: $20 to $28 per hour based on qualifications.
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