Director, Cleaning, Disinfection & Sterilization
Company: Karl Storz Endovision Inc
Location: Charlton
Posted on: January 26, 2023
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Job Description:
Company Overview
KSE specializes in production and servicing of minimally invasive
flexible endoscopes, with legacy devices based on fiber optic
technology, and next generation devices designed around the latest
video technologies. The main campus is located in Charlton MA, with
an Advanced Machining Center and SSU cleanroom located in Franklin
MA. The distribution facility for all US devices is located in
Auburn, MA. There are two additional subsidiaries in the US for
operations - a camera and CCU facility located in Goleta CA, and an
Operating Room design and installation team located in Houston
Texas. Our culture is built on a foundation of respect for people
and continuous improvement, consistent with organizations following
a lean philosophy. Speed, flexibility, and collaboration are at the
heart of the operating system, geared toward providing the best
value products to hospitals, clinics, and physician's offices all
over the world. Significant emphasis is placed on creating and
building a culture of diversity, equity, and inclusion, and
creating a safe environment where people can come to work and
contribute to their fullest potential.
Role Overview
The ideal candidate is skilled in collaborative leadership and has
successfully managed design and process validation and verification
testing for cleaning, disinfection, and sterilization (CDS) to
support FDA Class II device 510k submissions and/or Class III
device PMA submissions. The candidate will have experience with
market surveillance and complaint management investigation for
issues relating to CDS. Finally, they will have experience in
effectively supporting and working within cross functional teams in
bringing sterile single use (SSU) devices to market.
This role will coach a team of 5 specialists and technicians in
conducting screening/feasibility experiments, while managing
relationships with manufacturers of CDS equipment deemed compatible
with our devices. They will also manage the external contracting of
tests used for design verification and for root cause
investigations for issues and problems relating to CDS. Our devices
include equipment manufactured in the US, imported from Germany,
manufactured by KARL STORZ, and 3rd party devices purchased for
sales in the US. This role will frequently interface with the
Regulatory, Sterilization, Biocompatibility team located in
Germany, as well as the Regulatory Affairs Team based in the US,
the Global R&D team, Product Management based in Germany, and
US operations.
Key Responsibilities
* Ensures 510k/PMA design validation and verification testing and
documents supporting CDS claims are complete, and fact based for
devices legally marketed in the US
* Creates and executes appropriate and efficient pre-clinical
safety testing based on US standards
* Determines US regulatory requirements for new/proposed products
in biocompatibility (in collaboration with RSB in Germany)
* Troubleshoots complaints and problems relating to cleaning and/or
sterilization of devices marketed in the US. Drives to root cause
and ensures effective countermeasures are implemented.
* Leads and manages the creation, approval, and maintenance of
reprocessing testing documentation for US marketed medical
devices.
* Stays current with emerging technologies and regulation
pertaining to reprocessing and to SSU devices.
* Communicates with US and Canadian regulatory agencies as required
to advance product approvals and submission determination of
medical devices, working closely with US RA.
* Ensures AAMI recommendations are assessed against KS US based
policies and procedures and deployed as appropriate.
* Ensures qualified test houses used for KS are audited on a
periodic basis and maintain appropriate certifications.
* Works with operations to ensure that appropriate process controls
are in place to support successful cleaning, disinfection,
sterilization, and biocompatibility requirements from a production
perspective.
Key Requirements
* Bachelor of Science in Toxicology, Biology, Chemistry, Chemical
Engineering, or Material Science required. Advanced degree
desirable
* 12+ years relevant experience in reprocessing technologies.
* Experience bringing SSU devices to market in the US
* Knowledgeable with the Code of Federal Regulation pertaining to
medical devices, in particular regulations and standard for
cleaning, disinfection, sterilization, and biocompatibility
(toxicology)assessments.
* Knowledgeable with EN ISO 13485 standards, with ST91 and
additional relevant guidance documents
* Humble inquiry leadership skills and ability to coach and develop
others.
* Strategic thinker able to bring together competing points of view
and create a path forward
* Demonstrates data driven and fact-based approaches
* Certifications in toxicology or biocompatibility desirable
* Able to effectively communicate with notified bodies and with the
FDA.
* Excellent skills with Microsoft products - Word, Excel,
PowerPoint. Advanced use of Excel for data analytics required.
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Keywords: Karl Storz Endovision Inc, Worcester , Director, Cleaning, Disinfection & Sterilization, Executive , Charlton, Massachusetts
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