This position manages and provides support for the activities of the reprocessing qualification/validation for all KARL STORZ (KS) products, including cleaning, disinfection and sterilization studies with existing and upcoming chemicals and equipment for reprocessing. This position coordinates activities with KS global counterparts to support product cleaning, high level disinfection and sterilization regulatory requirements and global product marketing position. This position supports the global Quality and Regulatory Affairs team towards common objectives and global quality unification processes. This position develops and leads multiple local as well as international projects in an area of technical expertise which requires use of advanced techniques and/or knowledge.
MINIMUM KNOWLEDGE, EDUCATION AND SKILL REQUIREMENTS
A minimum education level of bachelor's degree in Microbiology, Biology, Chemistry, or Biochemistry is required.
Prior hands on laboratory testing experience in Microbiology, Biology, Chemistry and/or Biochemistry or within the medical device industry are preferable but not necessary .
Experience with reprocessing of reusable medical devices is preferred. Familiar ity with sterilization (steam, EO, vapor hydrogen peroxide, liquid chemical sterilant processing system), high level disinfection (manual and automated processes), and cleaning (manual and automated processes).
Requires experience with protocol development, execution and report writing.
The individual should be familiar with FDA regulations, standards, guidelines and overall system requirements as well as other medical device-related regulations (GMP, QSR). Knowledge of relevant sections of the Code of Federal Regulations pertaining to medical devices in general and quality management systems is preferred.
Familiarity with reprocessing-related standards and guidance documents (AAMI TIR12, ISO 11138, AAMI TIR 30, ISO 15883, AAMI ST 58, ANSI/AAMI ST79, ANSI/AAMI/ISO 17665-1,ISO 11135, ANSI/AAMI ST 41, etc.) for the medical device industry is preferred .
Travel: up to 25 percent
Must be punctual, able to sustain attendance guidelines, and work hours as assigned.
Must possess excellent verbal and written communication skills, and ability to effectively communicate with internal and external personnel. Must be self-motivated, confident, and energetic individual.
Strong project management and presentation skills with the ability to engage employees and senior management preferred.
Must also be an effective problem solver who is self-directed and able to perform duties with little to no supervision
Proficient in computer systems (MS Office Suite, etc.).
Possess exceptional organizational skills and the ability to multi-task
DUTIES AND RESPONSIBILITIES
Determine regulatory requirements/status for new/proposed products in cleaning, high level disinfection and sterilization as well as other related areas.
Provide technical expertise and support to the submission team to facilitate marketing clearance from the FDA (US), Europe and Health Canada for KARL STORZ devices, via reprocessing validation.
Manage reprocessing validation activities at test facilities for re-usable devices. Develop test protocols, oversee the implementation of the studies by external laboratories, and draft final reports.
Assists in assuring compliance to Quality System Regulation. Support to establish standard operating procedures to ensure compliance to KARL STORZ company policies, the Code of Federal Regulations, Canadian Medical Device Regulations and ISO 13485.
Organize ongoing preparedness activities in anticipation of external audits by FDA, Notified Bodies, and other regulatory agencies.
Demonstrates leadership and initiative in key projects, teams, and group to meet objectives and scientific principles. Makes positive contributions and proposals. Operates with substantial latitude for decisions and actions.
Performs work accurately, with high skills in many complex tasks, and with high quality. Remains abreast of the field and has expertise in compliance standards. Reviews current literature and provides technical guidance.
Develops and maintains open communication with all contacts. Interfaces effectively with department team members internationally. Maintains a constructive team member approach, dialogues with employees and resolves issues in a positive manner. Demonstrate respect, listening / communicating openly, involving, and recognizing the value of others. Pursues win/win commitment to meeting customer needs and improving services.
Interfaces effectively with outside department/suppliers with effective coordination. Develops contacts with peers in industry and contributes to issues/guidance.
Supports Marketing/Sales towards better product marketing position and achieve better profitability via reprocessing-related activities.
Applies professional judgments, high level experience, and analytical thinking in assessing situations and evaluation information. Anticipates impact of actions and makes effective decisions.
Demonstrate commitment to serving customers, communication with the customer, and create a welcoming environment for KSEA employees and our customers.
Adhere to all KSEA Policies and Procedures as they apply.
Protect employee and customer confidentiality.
Adhere to current organizational performance improvement priorities.
Make recommendations and take actions to improve structure, system or outcomes.
ENVIRONMENT, HEALTH AND SAFETY:
Must be committed to a high standard of safety and be willing and able to comply with all environmental and safety laws and regulations, including the environmental and safety policies of the company. Must be willing to report actual and potential environmental and safety violations to appropriate supervisory and/or management personnel.
The incumbent in this position is responsible for knowledge of and adherence to environmental policies and company procedures as they relate to ISO 14001.
Must not pose a direct threat or significant risk of substantial harm to the safety of himself/herself or others.
Responsible for informing the Company if he/she is taking medications or if there are any other circumstances that would interfere with safe performance of job duties.
The incumbent in this position is responsible for knowledge of and adherence to the policies and procedures as they relate to the requirements of FDA Quality System Regulation, ISO 13485 and ISO 9001.
INTERPERSONAL AND COMMUNICATION SKILLS
Must be able to maintain productive working relationships with co-workers.
Must treat fellow employees with respect.
OTHER DUTIES AND RESPONSIBILITIES (Other duties consistent with the general nature and focus of the position and/or the goals and objectives of the department may be assigned.)
OTHER PHYSICAL, MENTAL, INTERPERSONAL AND COMMUNICATION REQUIREMENTS
Karl Storz Endovision Inc