Associate Manager, Quality Systems

Job Description

This position provides leadership to the Quality System department staff who are responsible for the continued development and maintenance of the Quality Management System documentation and QSR / ISO compliance functions within Olympus.

This position will work jointly with all departments to develop and maintain procedural documents while ensuring that the Quality systems standards and compliance activities are indeed maintained and in support of all OSTA service and repair activities.

Job Duties

• Manage staff responsible for the maintenance of key quality management system activities including document and change controls, CAPA activities internal and external audits and special projects related to the maintenance and improvement of quality management systems at Olympus facilities in the U.S.
• Supervise personnel responsible for document and change activities at the San Jose and Bartlett facilities including but not limited hosting the Change Control Board meetings, status, monitoring, reporting, follow-up verification and closure activities associated with document and change controls.
• Support these activities at other Olympus facilities within the U.S. as needed. Support current and future quality management system development and QSR / ISO compliance activities aimed at defining existing systems and promoting quality improvements consistent with our QSR / ISO compliance strategy and business needs at Olympus facilities within the U.S.
• Work with management and technical personnel from various departments within Olympus to understand existing systems and processes for purposes of identifying and documenting the most efficient workflow sequence needed to support the development maintenance and improvement of quality management systems at Olympus facilities within the U.S.
• Oversee CAPA activities related to the San Jose and Bartlett facilities including but not limited to status monitoring, reporting, follow-up verification and closure activities.
• Support CAPA activities at other facilities within the U.S. as needed.
• Support routine and periodic audit and assessment activities at the San Jose and Bartlett facilities including internal and external audits and inspections required to ensure that QSR / ISO compliance is maintained at all levels of the organization.  Additionally, provide follow-up to any resultant findings to ensure related corrective action activities are completed in a robust and timely manner ·
• Support preparation and analysis of data in Quality Progress Meetings and Management Reviews.
• Manage site Quality dashboard KPI activities and oversee special projects related to the development maintenance and improvement of Quality Management Systems at Olympus facilities in the U.S.
• Identify and facilitate process and general improvements within the repair procedures, embracing a culture of continuous improvement and the utilization of quality techniques in problem solving ·
• Provide support for similar activities at other Olympus facilities as needed. Support development and testing of associated software used in support of quality management systems.
• This may include but is not limited to specification development, test script development, test script execution and the compilation and storage of software validation documentation.
• Teach and train other functional group employees on Quality processes and procedures as the need is recognized, ·
• Perform all other essential duties as directed.

Job Qualifications

Required:

• BS degree in an engineering, technical writing, or life science discipline; or equivalent experience (preferably with specialization in Quality Assurance).
• Minimum of 5 years of experience in a QMS Specialist/Sr. Specialist role in the medical device, pharmaceutical, or biotech industry.
• Experience with internal and external audits preferably backroom support.
• Understanding of root cause analysis and QSR compliant CAPA methodology.
• Leading document and change control initiatives. Prior leadership / supervision experience is a plus.
• Strong working knowledge of production and process controls – including process. development, process validation, use of statistics in decision making, sterile packaging, and working in controlled environments.
• Working knowledge of ISO 13485, 21 CFR Part 820, EUMDR, Medical Devices Directive, Canadian Medical Device Regulations, ISO 14971 and other applicable medical device industry US and international standards.
• Must be highly organized, flexible to changing priorities, team-oriented with a vision of the business, and excellent at prioritization and multitasking.  Time/project management skills are essential.
• Able to foster positive collaborative relationships across all lines of the Company.
• Works with a passion for continuous improvement and quality.
• Strong communication skills.
• Excellent written skills required.
• Demonstrates the highest ethical standards actively promotes trust respect and integrity in all dealings both inside and outside the Company.
• Travel: 5-10% mainly domestic.
• Prolonged periods of sitting at a desk and working on a computer.
• Must be able to lift 15 pounds at times.
• Must be able to travel as necessary to meet supply chain needs.