Product Performance Specialist

KARL STORZ is a global company dedicated to the design and manufacturing of precision medical equipment since 1945.  Our breakthroughd in endoscopy have made our name synonymous with quality innoviations in this field.

Individual is responsible for monitoring performance trends for products manufactured at Karl Storz (KS) North America Region (NAR) production locations. Responsibilities include monitoring post sale product performance evaluation for manufactured products as well as similar products manufactured by competitors; developing a first-hand understanding of how the products are actually being used and handled in the field by KS customers; and evaluating and managing product complaint investigations to ensure that a "root cause", where discoverable, is identified in support of the investigation. This position assists in the creation of risk management files, and reviews them periodically to ensure that they include any known potential risks and are updated appropriately as previously unidentified risks emerge. This position also assists in identification of human factors improvement opportunities for the manufactured product(s).

This position may participate in other QMS related activities, such as: Supplier Evaluation and Management, Employee Training, CAPA, Engineering Change Reviews, Continuous Improvement, and Cost of Quality Measurement.

This position, working with the location Quality Systems Manager, assists with ensuring that the established and implemented QMS satisfies ISO 9001:2000, ISO 13485, the 93/42/EEC Medical Device Directive in support of European Operations, as well as other applicable EU directives, the Canadian Medical Device Regulations, and the U.S. FDA cGMP/QSR.

This position does not have employees directly reporting to it, but is expected to engage in regular and necessary communication with employees at all levels throughout the facility as well as the NAR. The person in this position is expected, as required, to work in close collaboration with European divisions of Karl Storz to esnure that non U.S. requirements continue to be effectively and efficiently met. This person is expected to spend enough time in the field to ensure a thorough knowledge of how the products are used by KS customers.

Travel: Up to 25% travel during the year.
Comply with current laws, other regulatory agencies, and institutional and operating systems.
Protect employee and customer confidentiality.
Adhere to current organizational Performance Improvement priorities.
Be knowledgeable at all times of current product performance issues and make decisions regarding actions necessary to maintain expected product performance levels or to correct product performance problems.
Provide reports to KS NAR production locations regarding the current state of post sale product performance.
Work effectively with any employees involved with product performance evaluation, especially the designated complaint handling unit.
Regularly advise KS NAR production locations, through direct communication and special reports, of significant events (positive or negative) regarding product performance levels.


Associate's Degree required; Biomedical Engineering certifications/credentials preferred.
5 to 9 years of relevant experience.
Exceptional organizational skills and the ability to multi-task.
Additional qualifications desired: Associate's Degree in Life Sciences, Engineering, Regulatory Affairs, Law, or other discipline with an established curriculum related to Quality management Systems and Regulatory Requirements.
Reasonable experience with FDA and ISO regulations and standards, and CMDR (Canadian Medical Device Regulations).
Proven working knowledge of sterile reprocessing requirements and hospitals' use thereof.
Excellent collaboration and team building track record.
Ability to achieve consensus at any level, including the local management at the manufacturing location.
Prior experience in hospital or OR environments, including blood-borne pathogen training.