Job Description:

Company: KARL STORZ North America (KSNA)

Job Code: 10719

Pay Grade: US-B15

Description

KARL STORZ SE & Co. KG based in Tuttlingen, Germany, is a family-owned, global company committed to benefiting humanity by advancing medical technology through innovation and education.

For more than 70 years, KARL STORZ has been dedicated to earning its international reputation as a leader that designs, engineers, manufactures, and markets all its products with an emphasis on visionary design, precision craftsmanship, and clinical effectiveness.

POSITION SUMMARY

I. Provide support and guidance within the global organization regarding regulatory compliance as it pertains to the biocompatibility of medical devices. Provide input and support with respect to biocompatibility of materials for the development of new products and changes to existing products. Frequently interfaces with Global PDI (R&D), Global PM (Product Management), Manufacturing Engineering, and Global Regulatory Affairs and Quality Management.

- MINIMUM KNOWLEDGE, EDUCATION AND SKILL REQUIREMENTS

- Bachelor's degree in Biology, Chemistry, Chemical Engineering, Material Science or Engineering.

- 0-2 years of relevant experience.

- Relevant experience in the regulated environment, either at another medical device company or in a contract laboratory

- Technical background sufficient to understand devices and medical procedures so that adequate justification, description and explanations can be documented to support the FDA and other regulatory bodies in product submissions.

- Knowledge of relevant sections of the Code of Federal Regulations pertaining to medical devices in general and more specifically, biocompatibility regulations / standards

- Ability to read and interpret Regulatory/Legal documents and determine the required compliance activities.

- Ability to work with KARL STORZ global QM/RA team members and other departments, as well as external customers, vendors, consultants and regulatory authorities.

- Excellent technical writing ability, good organizational skills, good computer skills (e.g., MS Office), project management skills, and good communication skills

- Must be extremely well organized.

- Ability to work independently with minimal supervision.

- Ability to make decisions that support the business goals and objectives.

- ESSENTIAL 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.)

- Understand and apply regulatory requirements/status for new/proposed products in material biocompatibility and other related areas.

- Support by product pre-clinical safety testing based on international standards and regulatory requirements associated with biocompatibility and toxicology.

- Provide technical expertise and support to the submission team on obtaining marketing clearance for all Global KARL STORZ devices, with regard to biocompatibility certifications.

- Support the creation, approval, and maintenance of biocompatibility and toxicology testing and documentation for medical devices.

- Update and maintain the company's biocompatibility database.

- Provide support within the global organization regarding regulatory compliance as it pertains to biocompatibility and toxicology issues associated with medical devices.

- Assist in supplier qualification by reviewing technical documentation as requested.

- Assist in assuring compliance to Quality Management System Requirements as it relates to biocompatibility and toxicology issues. Support the establishment of standard operating procedures to ensure compliance to KARL STORZ company policies, the Medical Device Directive, Code of Federal Regulations, Canadian Medical Device Regulations, ISO 13485 Medical devices -- Quality management systems and the Japanese Pharmaceutical Affairs Law. Update QMS procedures as necessary.

- Develop and maintain open communication with all contacts. Interface effectively with department team members. Maintain a constructive team member approach and resolve issues in a positive manner. Demonstrate respect, listening / communicating openly, involving and recognizing the value of others. Pursue win/win commitment to meeting customer needs and improving services.

- Evaluate changes in products per organizational risk management practices to ensure effective, safe and complaint devices are released to the market in accordance with current state and federal standards.

- Must establish productive, effective working relationships with all coworkers including global partners

- The incumbent in this position is responsible for knowledge of and adherence to environmental policies and company procedures as they relate to ISO 14001.

- 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 (current revisions).

- 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.)

- Routine administrative tasks required to support biocompatibility testing and coordination with labs

Some domestic and international travel may be required.

#LI-NM1

Working at KARL STORZ during COVID-19

KARL STORZ will continue to maintain a safe work environment for our employees. During the interview process, we encourage you to ask how COVID-19 may impact the role you are seeking. The impact and/or company-issued personal protection equipment may vary based on the nature and location of the role. Please to learn more about our response to COVID-19.

Employee Benefits Program Overview for U.S. Locations

- Medical / Dental / Vision including a state of the art wellness program and pet insurance, too!*

- 3 weeks' vacation, 10 holidays plus paid sick time*

- 401K retirement savings plan providing a match of 60% of the employee's first 6% contribution

- Section 125 Flexible Spending Accounts

- Life, STD, LTD & LTC Insurance

- Tuition reimbursement of up to $5,250 per year

- Fitness reimbursement up to $200 annually

- Employee referral program of up to $2,000 per hire

- And much more!

*Field sales, internships and part-time employees are not eligible except for where required by state law.

Non-employees, including temporary workers and consultants, are not eligible to participate in KARL STORZ benefits program.

KARL STORZ reserves the right to change or modify the employee's job description whether orally or in writing, at any time during the employment relationship. Additionally, KARL STORZ, through its supervisors, may require an employee to perform duties outside their normal description within the sole discretion of the supervisor. Employee must comply will all applicable KARL STORZ policies and procedures.

Equal Employment Opportunity Statement

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status. KARL STORZ is an Equal Opportunity Employer supporting EOE/M/F/Vet/Disability.

Reasonable Accommodation

If, at any point in the application process (including hiring), a candidate would like to request a reasonable accommodation due to a disability or a religious need, please email us at Taleo_Administrator@karlstorz.com and we'll be happy to engage in an interactive process with you.

Notice to Employment Agencies

This recruitment assignment is being managed directly by KARL STORZ's Human Resources team. Human Resources will reach out to our preferred, contracted agency partners in the rare instance

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