KARL STORZ United States is currently looking for a Product Safety & Vigilance Specialist . This role is responsible for identifying, assessing, communicating, and developing action plans to address real or theoretical product safety risks. In addition, this person ensures compliance with regulatory standards and guidelines, and corporate standard operating procedures as they relate to the global medical device reporting and complaint management; ensures clear and balanced communication and processing of potential MDR's, in collaboration with European Headquarters and other internal and external stakeholders, as subject matter expert; and provides guidance and advice and works with regulatory agencies.
Responsibilities

• 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

• 3-5 years' experience in a highly regulated environment - preferably medical device/pharma industries. Experience in Quality, Product Safety, Product Surveillance or Vigilance preferred.
• 4 year-degree or commensurate experience may be substituted for degree requirement. Completion of commercial training or medical training as a health care professional with administrative experience.
• 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
• High communication and conflict resolution skills
• Solution-oriented

Preferences

• 5 years of experience in a highly regulated environment

#LI-CW1
Your Benefits

• Medical / Dental / Vision including a state-of-the-art wellness program and pet insurance, too!*
• 3 weeks vacation, 11 holidays plus paid sick time*
• Up to 8 weeks of 100% paid company parental leave**
• 401(k) retirement savings plan providing a match of 60% of the employee's first 6% contribution (up to IRS limits)
• Section 125 Flexible Spending Accounts
• Life, STD, LTD & LTC Insurance
• We prepay your tuition up to $5,250 per year! - Tuition pre-imbursement
• Fitness reimbursement of 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 where required by state law.
Non-employees, including temporary workers and consultants, are not eligible to participate in the KARL STORZ benefits program.
**To include, maternal/paternal leave, adoption, and fostering of a child.

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. Employees must comply will all applicable KARL STORZ policies and procedures.
Credentialing requirements at KARL STORZ
KARL STORZ is committed to maintaining a safe work environment for our employees and customers. Most field-based roles at KARL STORZ require hospital credentialing/health screens as a condition of employment. Credentialing can include required vaccinations, health screens & other requirements as outlined by our customers. During the interview process, we encourage you to ask how credentialing/health screens may impact the role you are seeking and if you require any reasonable accommodations regarding these requirements.
Pay Transparency
The pay range and/or hourly pay rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job posting and may be modified in the future. When determining a specific team member's base salary and/or hourly pay rate, several factors will be considered including such things as location, specialty, service line, years of relevant experience, education, professional credentials, internal equity, and the amount budgeted for the role.
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 taoperations@karlstorz.com.
Get in Contact