Global Vice President Design Control at Olympus Corporation of the Americas in Center Valley, PA
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 Global Vice President - Design Control - TSD will oversee all Quality Activities in New Product Development for the Therapeutic Solutions Division (TSD). This person will be responsible for all Design Control activities in nine design centers around the world (Seattle, Brooklyn Park, St Louis, Westborough, Golden, Co, Hamburg, Berlin, Cardiff, and Or Akiva). They will execute the Olympus QMS and be directly responsible for the Design Control Quality Organization - including Design Control Engineering, Microbiology, Sterilization, Biocompatibility, Risk Management, Product Cyber, Sustaining Engineering, Security and the Human Factors Engineering. They will provide leadership, strategy, vision, oversight, training and mentoring to this organization for new product development and end to end product quality. Job Duties Develops and executes vision and strategy for the end-to-end Product Design Assurance efforts. Mentors and leads the Design Assurance Quality Engineering staff supporting new product development and sustaining engineering projects across multiple sites. Mentors and leads the Microbiology, Sterilization and Biocompatibility staff supporting new product development, sustaining engineering projects and routine production across multiple sites. Mentors and leads the Human Factors/ Usability Team supporting new product development and sustaining engineering projects across multiple sites. Champion and subject matter expert for customer and patient focused end to end Risk Management. Supports complaint investigations, signal detection, product issue escalations and a closed-looped Post Market Surveillance process. Supports facility audits by outside agencies (i.e., FDA, ISO / MDSAP) point of contact and subject matter expert to demonstrate compliance to regulatory requirements and the Olympus Design Control System. Budget responsibility for the TSD Design Control Quality organization. Stakeholder and collaborator with senior management relating to project, process, business, and quality decisions. Other Quality Assurance responsibilities as assigned by Management. Job Requirements REQUIRED QUALIFICATIONS Minimum requirements are a Bachelor's degree or equivalent in a Life Science, Engineering, or Physical Science with an advanced technical degree; Master's degree preferred. Minimum of 15 years of experience in quality management with at least 5-7 years of senior management experience and 5 years of new product development experience in a global position that is in a regulated environment in the MedTech industry. Other Considerations (travel/hours availability, etc.):
Global role:
The individual will be expected to schedule meetings that work for multiple time zones and well as 20 to 35% travel should be expected. PREFERRED QUALIFICATIONS Demonstrated comprehensive expertise in the applied interpretation of worldwide regulatory standards and laws applicable to the MedTech industry e.g., ISO, QSR, GMP, GLP, GCP, HIPAA. Demonstrated knowledge of and experience in pre-market regulations including regulatory, risk management, and cyber security processes. Proven track record in a global execution of New Product Development delivering robust, customer, and patient focused products. Demonstrated expertise in the design, implementation and measurement of quality systems and metrics in the design control space. Proven track record to drive value and product differentiation through the design control team. Focused, target driven with a positive, can-do attitude and a desire to improve patient experience as well as company performance. Strong technical skills related to product quality including Voice of Customer translation to design specifications, human factors, CTQ cascades, design characteristics, verification & validation, test method validation, process validation, inspection techniques and statistics. Initiative in innovative approaches to quality and compliance in a fast-paced changing business environment. o Excellent written and oral communication and organizational, project management skills.
Salary Range:
$250K -- $500K+
Minimum Qualification
Design & UXEstimated Salary: $20 to $28 per hour based on qualifications.
Global role:
The individual will be expected to schedule meetings that work for multiple time zones and well as 20 to 35% travel should be expected. PREFERRED QUALIFICATIONS Demonstrated comprehensive expertise in the applied interpretation of worldwide regulatory standards and laws applicable to the MedTech industry e.g., ISO, QSR, GMP, GLP, GCP, HIPAA. Demonstrated knowledge of and experience in pre-market regulations including regulatory, risk management, and cyber security processes. Proven track record in a global execution of New Product Development delivering robust, customer, and patient focused products. Demonstrated expertise in the design, implementation and measurement of quality systems and metrics in the design control space. Proven track record to drive value and product differentiation through the design control team. Focused, target driven with a positive, can-do attitude and a desire to improve patient experience as well as company performance. Strong technical skills related to product quality including Voice of Customer translation to design specifications, human factors, CTQ cascades, design characteristics, verification & validation, test method validation, process validation, inspection techniques and statistics. Initiative in innovative approaches to quality and compliance in a fast-paced changing business environment. o Excellent written and oral communication and organizational, project management skills.
Salary Range:
$250K -- $500K+
Minimum Qualification
Design & UXEstimated Salary: $20 to $28 per hour based on qualifications.
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