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Vice President, Manufacturing Quality

2 months ago

Lehigh County, United States Olympus Full time

Job Description

The Vice President, Manufacturing Quality, ESD will organize and oversee the Quality Assurance organizations, Quality Management Systems, Quality objectives, and regulatory compliance for the Olympus manufacturing plants primarily focused on ESD product lines. The individual in this role will represent Quality on the ESD Division Leadership team and collaborate across functions to deliver on Quality objectives across all aspects of Quality affecting ESD business. Manufacturing plants Quality leaders from associated Olympus manufacturing plants will report to this position either directly or through regional multi-plant Quality leaders. The individual in this role will be providing strategic direction and will establish a Quality strategy to improve, standardize and optimize the quality deliverables and execution of manufacturing Quality and compliance objectives across ESD manufacturing plants. The individual in this role will be responsible for managing and facilitating regulatory audits and inspections and lead execution of commitments to regulators.The individual in this role will directly oversee the following manufacturing locations in Japan and Europe: Aizu, Hinode, Shirakawa, Nagano, Aomori, Hamburg, and Midenmeer. In addition, this role will work closely with the Vice President of Manufacturing, TSD to oversee ESD production for remaining manufacturing sites supplying ESD business division. This role will also oversee repair facilities located within the manufacturing sites and will work closely with Vice President of Quality for Repair to ensure alignment of the standard practices and processes across all repair locations. The following roles will report into this role directly: Executive Director, Manufacturing Quality (Japan), Director of Quality Engineering, Quality Leaders at each manufacturing location, Director of Quality – Process Development. This role will also oversee performance indicators, quality system effectiveness, Management Review process/execution, internal audit, QMS design, external audits, supplier management, non-conformance, CAPA and other QMS elements governing associated manufacturing plants. The Vice President of Manufacturing Quality will work closely with other functions such as Operations, Service, Repair, Post Market Quality, Regulatory Affairs, Medical Affairs and others to ensure that the Quality strategy and operating objectives of the Manufacturing Quality teams are designed in support of the company objectives.


Primary Responsibilities: The VP, Manufacturing Quality, will focus on building and developing the following key competencies and processes: 1. Ensuring that programs to reduce product failures associated with manufacturing processes are identified, prioritized and implemented2. Implementing programs to improve product performance through enhancement of manufacturing processes. 3. Drive data driven approach to identify areas of Quality, Compliance and Customer dissatisfaction 4. Improving Efficiency of Quality organization and processes in support of manufacturing activities 5. Create a strong link into the Design Assurance and Service and Repair organizations to ensure consistency of test methods, repair practices and acceptance methodologies 6. Design and implement effective quality management system across manufacturing plants. 7. Develop strong and transparent KPIs to oversee and assess Quality and Compliance performance across all manufacturing plants. 8. Implement programs to reduce internal non-conformances. 9. Manage internal and external audits and inspections. 10. Improve and maintain a customer focused Quality Mindset throughout the organization

Job Duties

Manages and develops Quality organizations in support of manufacturing plants. Builds and maintains Quality Management Systems for manufacturing plants. Manages and ensures audit readiness for internal and externa audits and inspections. Tracks and improves Key Quality and Compliance Process Indicators for all manufacturing plants. Governs and ensures through execution of the Management Review for manufacturing plants. Represents Quality Manufacturing leadership teams. Ensures disciplined execution of the Quality Systems requirements across each manufacturing plan locations. Works closely with R&D and Service and Repair groups to ensure consistency of processes. Drives Quality improvements, reduction in failures, non-conformances and recalls. Sets and improves Quality Culture and Mindset across all Olympus manufacturing plants.

Job Qualifications

Required:

Bachelor's degree or equivalent in Engineering or Physical Science with an advanced technical degree and MBA preferred.  Minimum of 15 to 20 years of experience in quality management or compliance function with at least 5-7 years of management experience in a global position in a regulated environment in the MedTech industry. Demonstrated comprehensive expertise in the applied interpretation of worldwide regulatory standards and laws applicable to the medical device industry such as: ISO, QSR, GMP, GLP, GCP, HIPAA. Demonstrated expertise in the design, implementation and measurement of quality systems and metrics. Since this is a Global role, the individual will be expected to schedule meetings that work for multiple time zones and well as up to 50% travel should be expected.

Preferred:

Experience with durable medical equipment and sterile disposable medical devices within Med Tech industry is strongly preferred. Initiative in innovative approaches to quality and compliance in a fast-paced changing business environment. Excellent written and oral communication and organizational, project management skills. Excellent interpersonal and leadership skills with diverse cultural approach. Why join Olympus? Here, people matter—our health, our happiness, and our lives. Competitive salaries, annual bonus and 401(k)* with company match Comprehensive Medical, Dental, Visions coverage effective on start date 24/7 Employee Assistance Program Free virtual live and on-demand wellness classes Work-life balance supportive culture with hybrid and remote roles 12 Paid Holidays Educational Assistance Parental Leave and Adoption Assistance Volunteering and charitable donation match programs Diversity & Inclusion Programs including Colleague Affinity Networks On-Site Child Daycare, Café, Fitness Center** *US Only **Limited locations