Product Safety and Vigilance Specialist

Company: KARL STORZ Endoscopy-America, Inc. (KSEA)

Job Code: 12406

Pay Grade: US-C16

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 75 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.

KARL STORZ is currently seeking Product Safety and Vigilance Specialist who will assess, communicate and develop action plans to address real or theoretical product safety risks. In this role, you will ensure compliance with regulatory standards and guidelines, and corporate standard operating procedures as they relate to the global medical device reporting and complaint management; ensure clear and balanced communication and processing of potential MDRs, in collaboration with European Headquarters and other internal and external stakeholders, as subject matter expert. In addition, you will provide guidance and advice and work with regulatory agencies.

This position will be based at our offices in El Segundo (Los Angeles), CA with an opportunity to work remote up to 3 days per week.

Responsibilities

Key responsibilities will include, but may not be limited to:

Participates in the investigation and assessment of potentially reportable events:

• Gathers, reviews, and analyzes data and documentation, performing product surveillance within North America for potential corrective action and continued improvement/product excellence.
• Reviews, evaluates, and interviews appropriate people regarding product complaints relative to the identity, quality, safety, and effectiveness of medical devices.
• Tracks and reports on all stages of the investigation process including data analysis, reporting, documentation review, coordination of complaints, device history reviews, compliance, and review and closure of complaints.

Assist with upstream and/or downstream processes to obtain additional information:

• Coordinates activities required for investigations, including failure analysis, nonconformance, and corrective and preventive action (CAPA), working with Engineering, Manufacturing, and Quality Assurance.

Ensure complete and consistent documentation of vigilance cases with timely processing to final closure:

• Documents the analysis of product complaints for trends and identification of potential corrective or preventive actions.
• Reviews and analyzes documentation and determines root cause or if there are any irregularities that may have related to reported product failures. Evaluates and determines risk of product failure.
• Develops proactive internal and regulatory risk minimization action plans for real and theoretical risks. Utilizes understanding of the scientific basis for diseases, adverse events, and knowledge of risk management tools to assess benefit versus risk.

Participates in multi-site product safety teams and Field Safety Corrective Actions:

• Supports the developing of project plans and contributes to completion of milestones associated with specific product safety teams and FSCA s.

Communicates with authorities and regulatory agencies on reported cases and market actions:

• Assists during FDA, ISO, or other third-party audits and implements or assists in implementing corrective and preventive actions.

Requirements

Our successful candidate will have excellent written and spoken business communication skills. They will also have demonstrated success working in a collaborative, service-oriented team environment.

Additional requirements include, but are not limited to:

• Bachelor’s degree or equivalent experience.
• 3-5 years’ experience in a highly regulated environment – preferably medical device or pharma industries. Experience in Quality, Product Safety, Product Surveillance or Vigilance strongly preferred.
• Strong PC skills (MS Office, SAP/R3)
• High customer and service orientation
• Conscientious, reliable and independent way of working
• Ability to work in a team and flexibility
• High communication and conflict resolution skills
• High sense of personal accountability and responsibility

#LI-CW1

Vaccine requirements at KARL STORZ due to COVID-19
KARL STORZ is committed to maintaining a safe work environment for our employees and therefore we require the COVID-19 vaccine for all of our employees unless otherwise due to an underlying medical condition or sincerely held religious beliefs. During the interview process, we encourage you to ask how COVID-19 may impact the role you are seeking and if you require a reasonable accommodation regarding the vaccine requirement see below on the process for requesting accommodation. Please click here to learn more about our overall 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 & Reasonable Accommodation Statement
KARL STORZ is committed to creating an inclusive space where employees are valued for their skills and unique experiences. To achieve this goal, we are committed to diverse voices and all applicants will receive consideration without regard to race, color, sex, national origin, disability, veteran status or any other protected characteristic. KARL STORZ is also committed to providing reasonable accommodations during our recruitment process. Should you need assistance or accommodation please email us at …@karlstorz.com.

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 additional talent options are required. Your respect for this process is appreciated. KARL STORZ does not accept unsolicited Agency resumes. Resumes received which were unsolicited by KARL STORZ Human Resources department will be ineligible for referral fees.
Associated topics: environment, fault, gauge, inspector, physician, risk, sewer system, scba, wastewater, wastewater treatment plant