Now Hiring - Clinical Specialist, Cleaning, Disinfection & Sterilization in Charlton, MA

Company: KARL STORZ Endovision, Inc. (KSE)

Job Code: 13106

Pay Grade:

Salary Range:

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.

Company Overview

KSE specializes in production and servicing of minimally invasive flexible endoscopes, with legacy devices based on fiber optic technology, and next generation devices designed around the latest video technologies. The main campus is located in Charlton MA, with an Advanced Machining Center and SSU cleanroom located in Franklin MA. The distribution facility for all US devices is located in Auburn, MA. There are two additional subsidiaries in the US for operations – a camera and CCU facility located in Goleta CA, and an Operating Room design and installation team located in Houston Texas. Our culture is built on a foundation of respect for people and continuous improvement, consistent with organizations following a lean philosophy. Speed, flexibility, and collaboration are at the heart of the operating system, geared toward providing the best value products to hospitals, clinics, and physician’s offices all over the world. Significant emphasis is placed on creating and building a culture of diversity, equity, and inclusion, and creating a safe environment where people can come to work and contribute to their fullest potential.

Role Overview

The ideal candidate will support the Director of CDS-US, successfully ensuring compliance of existing devices legally marketed in the US. They will support the testing and documentation requirements for design verification and submissions of 510k for Class II and PMA for Class III devices. This position will ensure that planning and execution of risk analysis, root cause analysis, and efficacy analyses are timely and complete relating to and supporting 510k/PMA devices. The candidate will be a systemic thinker, capable of seeing the big picture, to distill the relevant facts. They will interface with customers as requested, in matters relating to effective cleaning and sterilization as it relates to the US IFUs. The candidate will also oversee compliance of third-party vendors and vertically integrated operations for cleaning and sterilization procedures and work instructions of sterile single use (SSU) devices, working close with QM, QA, and purchasing.

Key Responsibilities

• Uses the scientific method to draw fact-based conclusions during testing for design verification or for troubleshooting and problem solving relating to compliance topics or customer concerns relating to device efficacy and performance.
• Works with the director to ensure the QMS documentation and test data are accurate, timely, and controlled relating to US based CDS topics, ensuring compliance to 510k/PMA requirements
• Advises STORZ leadership and equivalent bodies regarding questions and topics pertaining to CDS
• Participates in standards committees and working groups on CDS topics in the US
• Successfully executes department goals set in collaboration with the director
• Supports sustaining and new product development projects
  
  

Key Requirements

• Bachelor’s degree in a healthcare related field or RN with a current license in good standing required
• Must be comfortable working in a fast-paced, growing and changing environment. Engages competently and professionally with customers, vendors, and test houses
• Minimum of 5 years relevant experience in healthcare profession. Nursing experience will be considered
• Minimum of 1 (one) years’ experience with medical device reprocessing methods
• Able to effectively communicate with notified bodies and with the FDA (written and oral)
• Strong collaboration skills – able to listen to all points of view and create effective solutions to issues or concerns
• Strong attention to detail
• Excellent skills with Microsoft products – Word, Excel, PowerPoint. Advanced use of Excel for data analytics required. Advanced use of Word for documentation requirements.
• Previous medical device or regulatory experience desired
• Previous infection control experience desired

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Pay Transparency

The salary 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.

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*
• Up to 8 weeks of 100% paid company parental leave**
  
• 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
• We prepay your tuition up to $5,200 per year! - Tuition preimbursement
  
• 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.

**To include, maternal/paternal leave, adoption and foster 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. 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 [please apply online].

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.