Senior Quality Systems Engineer - Global at Olympus Corporation of the Americas in Westborough, MA
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 Senior Quality System Engineer will develop, maintain and improve the Olympus Global Quality Management System (GQMS) to ensure it is compliant with all relevant international standards and business requirements. Actively drive the progress of Transform QARA to implement a GQMS. Implement industry best practices, procedural harmonization and seamless quality system integration through development of robust processes and quality plans. Act as an ambassador of global quality harmonization to share, develop, deploy and integrate strategic plans and practices across Olympus globally. To interface with users of the system to ensure the GQMS meets the business needs. Serve as Audit and CAPA coordinator as needed to ensure timely execution to QMS activities in these systems. Provides site expertise in the application of Quality Sciences including statistics data analysis problem solving and the creation of system solutions. Job Duties Ensures that a GQMS is established and implemented in accordance with all relevant International requirements and must report on the performance of the quality system to the Company's management as directed for review and as a basis for improvement of the quality system. Develop and actively participate in the implementation of global QMS process as part of Transform QARA (TQARA) as directed by the TQARA Project Manager and/or the VP for QMS Global. Provided global coordination of Audit, CAPA and other QMS processes as directed by the VP of QMS Global. Monitor and communicate status of global KPI metrics for Audit, CAPA and other QMS processes to global management. Provides expertise in the application of Quality Sciences including, statistics, data analysis, problem solving and the creation of system solutions for Quality System issues. Support and facilitate Internal and External Quality audit activity. Provide guidance on change management of GQMS and aid in the development of applicable training requirements. Support key Quality System and organizational initiatives and improvement activities (i.e. Transform QARA and other related Transform Olympus priorities). All Other Essential Duties as directed. Job Requirements REQUIRED QUALIFICATIONS Bachelors degree or equivalent and 5
years related experience and or training; or the equivalent combination of education and experience. Minimum of 5 years experience in medical device industry with strong quality systems background is essential. Candidate must have the ability to read write and communicate effectively in English is required; this requirement includes clear understandable speech and demonstrated comprehension skills. Other Considerations (travel/hours availability, etc.):
Up to 40% domestic and international travel. Must be available to work remotely outside of normal local business hours to work with teams globally. PREFERRED QUALIFICATIONS A strong expert understanding of a quality system and its components is required. Good analytical and organizational skills are required. Strong understanding and practical application of U.S. FDA QSR, EU MDR, Japanese PMD requirements as well as ISO13485, ISO14971, and other international QMS regulatory requirements. Strong attention to detail and accuracy are required. Experience training and/or mentoring others is required. Excellent verbal and written communication skills. Ability to create and deliver training to all levels within the organization. Strong people skills ability to effectively interact at all levels within the corporation. The ability to collaborate and work in a cross-functional environment. Must be able to demonstrate a working proficiency in operating a personal computer and to perform basic word processing/spreadsheet tasks using Microsoft Excel and Word applications. Fundamental understanding of problem-solving investigation and quality system verification techniques.
Salary Range:
$100K -- $150K
Minimum Qualification
Systems Architecture & Engineering, Quality AssuranceEstimated Salary: $20 to $28 per hour based on qualifications.
years related experience and or training; or the equivalent combination of education and experience. Minimum of 5 years experience in medical device industry with strong quality systems background is essential. Candidate must have the ability to read write and communicate effectively in English is required; this requirement includes clear understandable speech and demonstrated comprehension skills. Other Considerations (travel/hours availability, etc.):
Up to 40% domestic and international travel. Must be available to work remotely outside of normal local business hours to work with teams globally. PREFERRED QUALIFICATIONS A strong expert understanding of a quality system and its components is required. Good analytical and organizational skills are required. Strong understanding and practical application of U.S. FDA QSR, EU MDR, Japanese PMD requirements as well as ISO13485, ISO14971, and other international QMS regulatory requirements. Strong attention to detail and accuracy are required. Experience training and/or mentoring others is required. Excellent verbal and written communication skills. Ability to create and deliver training to all levels within the organization. Strong people skills ability to effectively interact at all levels within the corporation. The ability to collaborate and work in a cross-functional environment. Must be able to demonstrate a working proficiency in operating a personal computer and to perform basic word processing/spreadsheet tasks using Microsoft Excel and Word applications. Fundamental understanding of problem-solving investigation and quality system verification techniques.
Salary Range:
$100K -- $150K
Minimum Qualification
Systems Architecture & Engineering, Quality AssuranceEstimated Salary: $20 to $28 per hour based on qualifications.
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