Contract, Quality Engineer I

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 Complaint data and identify any significant trends.
• 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 Qualifications

Required:

• Bachelor’s Degree in Engineering or Scientific Discipline (or equivalent) required.
• Working knowledge of ISO 13485 and FDA Regulations 
• Domestic travel 10% 
• Occasional teleconference with global Olympus Corporation partners

Preferred:

• Minimum of 1-2 years operating in any Engineering position, preferably Quality Engineering in a highly regulated manufacturing environment (medical devices, biotech, pharmaceuticals, etc.) is optimal. 
• Basic understanding of good manufacturing practices (GMP) preferred 
• Proficient in Microsoft Office. Working knowledge of Datasweep, Adwatch, SAP and JDE preferred. 
• 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 
• 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 ·