Senior Laboratory Specialist - Cleaning, Disinfection & Sterilization - Charlton Massachusetts

Company: Disability Solutions
Location: Charlton, Massachusetts
Posted On: 04/26/2024

Role Overview As a Senior Laboratory Specialist in Cleaning, Disinfection, and Sterilization, you will play a crucial role in supporting our customers in healthcare facilities. The ideal candidate will collaborate closely with the Director of CDS to ensure compliance of our products with existing regulatory requirements in the United States. You will be responsible for supporting testing and documentation requirements for design verification and submissions of 510k for Class II and PMA for Class III devices. Additionally, you will oversee the planning and execution of risk analysis, root cause analysis, and efficacy analyses relevant to and supporting 510k/PMA devices. This role requires a systemic thinker, capable of seeing the big picture and distilling relevant facts.Key Responsibilities

• Provide expert guidance to healthcare professionals on cleaning, disinfection, and sterilization processes, including best practices, regulatory compliance, and the use of our products.
• Utilize scientific methods to draw fact-based conclusions during testing for design verification or for troubleshooting and problem solving.
• Collaborate with the director CDS to ensure the accuracy and timeliness of documentation and test data ensuring compliance to 510k/PMA requirements.
• Successfully executes department goals set in collaboration with the director.
• Oversees and coordinates testing activities performed internally or by external labs.
• Provide support for both sustaining and new product development projects.
• Travel: 5-10%, including visits to other KARL STORZ locations, trade shows/congresses, customer sites. Key Requirements
  • Bachelor's degree in healthcare science or related field, or Registered Nurse with a current license in good standing
    • Minimum of 5 years of relevant experience in healthcare profession; nursing experience will also be considered.
      • Minimum of 2 (two) years' experience with medical device reprocessing
      • Strong collaboration skills with the ability to consider various viewpoints and create effective solutions to address issues or concerns.
      • Strong attention to detail
      • Excellent proficiency with Microsoft products, particularly Word, Excel, PowerPoint. Advanced Excel skills for data analytics required, as well as advanced Word skills for documentation requirements.
      • Previous medical device or regulatory experience is desired.
      • Previous experience in infection control is desired. #LI-BL1Your 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 STORZKARL 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 TransparencyThe 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 StatementKARL 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 ContactBecky LedfordBecky.Ledford@karlstorz.com More...

              

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