Quality & Regulatory Manager - Medical Device / Equipment (Remote with travel)
Belimed is a leading supplier of medical and surgical instrument sterilization, disinfection, and cleaning products and services. We are headquartered in Zug, Switzerland, and look back on more than 50 years of history. We have offices in 9 countries worldwide and are represented in over 80 countries thanks to a strong network.We believe that great teams are the key to our success. At Belimed, you will work in an international environment with talented people, all of whom have dedicated themselves to making a difference in the safety and health of patients and medical staff.Quality & Regulatory Manager - Medical Device / Equipment (Remote with travel)Your tasks As the Quality and Regulatory Manager you will be responsible for quality control, quality assurance and regulatory affairs for the U.S. business unit.This position will require travel of approximately 30 days throughout the year. Locations include our South Carolina headquarters, as well as customer sites throughout the US territory and periodic visits to our sites in Europe.How you will impact Belimed and our clientsImplement the worldwide Belimed Quality Policy and derive appropriate programs and systems to support strategic direction and conduct training on those systemsAnalyze quality / regulatory information for current and prospective products and presents findings to local management and global counterpartsManage cases in the CAPA Management System regarding documentation quality, time deadlines and efficacy of Corrective and Preventive ActionsSupport the operation of the CAPA Management System and understand the meaning of Non-Conformance handling processes such as audit findings, non-conformance, complaints, investigations, and reportable incidentsTrack quality / regulatory training of all employees via standardized document control forms (QMS document control)Ensure the U.S. business complies with the requirements of ISO 13485 by managing the Integrated Management System (IMS)Partner with management to formulate and establish business improvement activities / goals that are accomplished within prescribed time frame and cost parametersConduct supplier and internal auditsAct as U.S. representative during on-site FDA inspectionsAct as the regulatory contact person for U.S. product and material related requirementsAct as U.S. representative for FDA registration of the organization (importer role)Review technical publications, articles, and abstracts to stay abreast of technical developments in industryAnalyze, evaluate and present (monthly / quarterly / annually) reported and responsible Quality Issues status and historyAttend and actively participate in quality / regulatory professional associationsUpdate and improve business processesDrive a continuous improvement culture within the US organization to include : Lead cross-functional Continuous Improvement events using DMAIC modelLead and train value stream mapping exercises to define processesWork with the site to implement or streamline / improve use of LEAN tools, 5S, Six SIGMA, etcSupport process owners in making recommendations for updating / improving the Integrated Management System (IMS)Act as key user for SAP Enable Now (SEN)Act as Business Analyst for Belimed US Quality & RegulatoryWhat you need to succeedBachelor’s degree in an Engineering related field or business administrationMinimum four years working with regulators in the medical industryMinimum eight years of process management experience including training, development and coachingMinimum six years of experience with the use and implementation of Quality Management SystemsISO 13485 Quality System experienceFDA QSR regulations experience (21CFR820 etc.)Public speaking and / or presentation experienceExcellent verbal and written skills in the English languageExperience in MS Office SuiteAbility to travel to the Charleston HQ on a quarterly basisAble to obtain a valid passport for occasional international travelAs a full-time team member, you will be eligible for our excellent benefits package to include medical, dental, vision, life and disability insurances, 401(k) with a company match, multiple paid time off programs, flexible work from home options and more!Belimed, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, sex (including pregnancy, gender identity or expression, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), political affiliation, military service, or other non-merit based factors. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
Belimed is a leading supplier of medical and surgical instrument sterilization, disinfection, and cleaning products and services. We are headquartered in Zug, Switzerland, and look back on more than 50 years of history. We have offices in 9 countries worldwide and are represented in over 80 countries thanks to a strong network.
We believe that great teams are the key to our success. At Belimed, you will work in an international environment with talented people, all of whom have dedicated themselves to making a difference in the safety and health of patients and medical staff.
Quality & Regulatory Manager - Medical Device / Equipment (Remote with travel)
Your tasks As the Quality and Regulatory Manager you will be responsible for quality control, quality assurance and regulatory affairs for the U.S. business unit.
This position will require travel of approximately 30 days throughout the year. Locations include our South Carolina headquarters, as well as customer sites throughout the US territory and periodic visits to our sites in Europe.
How you will impact Belimed and our clients
- Implement the worldwide Belimed Quality Policy and derive appropriate programs and systems to support strategic direction and conduct training on those systems
- Analyze quality / regulatory information for current and prospective products and presents findings to local management and global counterparts
- Manage cases in the CAPA Management System regarding documentation quality, time deadlines and efficacy of Corrective and Preventive Actions
- Support the operation of the CAPA Management System and understand the meaning of Non-Conformance handling processes such as audit findings, non-conformance, complaints, investigations, and reportable incidents
- Track quality / regulatory training of all employees via standardized document control forms (QMS document control)
- Ensure the U.S. business complies with the requirements of ISO 13485 by managing the Integrated Management System (IMS)
- Partner with management to formulate and establish business improvement activities / goals that are accomplished within prescribed time frame and cost parameters
- Conduct supplier and internal audits
- Act as U.S. representative during on-site FDA inspections
- Act as the regulatory contact person for U.S. product and material related requirements
- Act as U.S. representative for FDA registration of the organization (importer role)
- Review technical publications, articles, and abstracts to stay abreast of technical developments in industry
- Analyze, evaluate and present (monthly / quarterly / annually) reported and responsible Quality Issues status and history
- Attend and actively participate in quality / regulatory professional associations
- Update and improve business processes
- Drive a continuous improvement culture within the US organization to include : Lead cross-functional Continuous Improvement events using DMAIC modelLead and train value stream mapping exercises to define processesWork with the site to implement or streamline / improve use of LEAN tools, 5S, Six SIGMA, etc
- Support process owners in making recommendations for updating / improving the Integrated Management System (IMS)
- Act as key user for SAP Enable Now (SEN)
- Act as Business Analyst for Belimed US Quality & Regulatory
What you need to succeed
As a full-time team member, you will be eligible for our excellent benefits package to include medical, dental, vision, life and disability insurances, 401(k) with a company match, multiple paid time off programs, flexible work from home options and more!
Belimed, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, sex (including pregnancy, gender identity or expression, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), political affiliation, military service, or other non-merit based factors. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
