Auditors / Product Reviewer / Clinical Specialist

MTIC Academy; Lugano; Vor Ort; CHF 80’000 - 120’000; Vollzeit

Zusammenfassung

A leading company in medical device certification is seeking experienced Auditors and Product Reviewers to join their team. Candidates should have a university degree in a relevant field and several years of experience in the medical device sector, especially within quality management systems and regulatory compliance. This role involves assessing technical documentation and conducting audits to ensure conformity with European regulations for medical devices.

Qualifikationen

• Minimum 4 years of experience in the medical device sector.
• At least 2 years as an auditor for notified bodies.
• Lead Auditor training according to ISO 19011 as a plus.

Aufgaben

• Conduct technical documentation assessments and QMS audits.
• Review compliance with Medical Device Certification standards.
• Act as a lead auditor for conformity assessment activities.

Kenntnisse

Knowledge of MDD 93/42/EEC

Knowledge of EU Regulation 2017/745

Knowledge of ISO 13485

Knowledge of ISO 14971

Communication in English

Ausbildung

University degree in engineering discipline or chemical science or pharmacy

Jobbeschreibung

MTIC InterCert is growing steadily and successfully in all areas of Certification, particularly as a Notified Body in Medical Device Certification.

Technical Experts, Lead Auditors, Auditors and Clinical specialists for Conformity Assessment activities for Medical Devices according to Directive 93/42/EC and soon, for EU Regulation 2017/745 are always welcome to cooperate with our team at our offices in Europe: activities will include both technical documentation assessments and QMS audits, including EN ISO 13485 audits.

We are currently looking for the following additional specific requirements:

Auditor

• University degree in engineering discipline or chemical science or pharmacy
• Minimum 4 years of Work experience in medical manufacturer of which at least 2 years in quality management or as auditor for other notified bodies.
• Sound knowledge of MDD 93/42/EEC and Regulation (EU) 2017/745
• Sound knowledge of the main horizontal harmonized standards including, but not limited to ISO 13485, ISO 14971
• Knowledge of English language
• Lead Auditor training course according to ISO 19011 (40 hours) will be a plus
  
  

Product Reviewer/Final Reviewer

General Requirements:

• University degree in engineering discipline or chemical science or pharmacy
• Sound knowledge of Regulation (EU) 2017/745
• Sound knowledge of the main horizontal harmonized standards including, but not limited to ISO 14971, ISO 10993series, EN 62366
• Knowledge of English language
  
  

Specific Requirements

MDA 0303

Active Non-implantable Devices Utilising Hyperthermia / Hypothermia

• 4 years in the medical device sector or similar sector
• of which at least 2 years in design with manufacturers of medical devices for hyper/hypothermia, or
• at least 2 years in NB with experience in PR for hyper/hypothermic devices.
  
  

MDA 0306

Active non-implantable devices for extra-corporal circulation, administration or removal of substances and haemapheresis

• 4 years in the medical devices sector or similar, of which possibly
• at least 2 years in NB with experience in FR for active non-implantable devices for extra-corporal circulation, administration or removal of substances and haemapheresis, or
• at least 2 years of experience in design of active non-implantable devices for extra-corporal circulation, administration or removal of substances and haemapheresis with FR training to be carried out in NB
  
  

MDA 0311

Active non-implantable dental devices

• 4 years in the medical devices sector or similar, of which possibly
• at least 2 years in NB with experience in FR for active dental devices, or
• at least 2 years of experience in design of dental active devices with FR training to be carried out in NB
  
  

MDA 0316

Medical gas supply systems and parts thereof

• 4 years in the field of medical devices or similar, of which possibly
• at least 2 years of experience in design of medical gas delivery systems, or
• at least 2 years in NB with experience in PR for medical gas delivery systems.
  
  

MDN 1102

Non-active osteo- and orthopaedic implants

• 4 years in the field of medical devices or similar, of which possibly
• at least 2 years in NB with FR experience for orthopaedic implants, or
• at least 2 years of experience in design of orthopaedic implants with FR training, carried out by NB
  
  

MDN 1201

Non-active non-implantable devices for anaesthesia, emergency and intensive care

• 4 years in the field of medical devices or similar, of which possibly
• at least 2 years in NB with FR experience for non-implantable devices for anaesthesia, emergency and intensive care, or
• at least 2 years of experience in design of non-implantable devices for anaesthesia, emergency and intensive care with FR training, carried out by NB
  
  

MDN 1202

Non-active non-implantable devices for administration, channelling and removal of substances, including devices for dialysis

• 4 years in the field of medical devices or similar, of which possibly
• at least 2 years in NB with FR experience for Non-active non-implantable devices for administration, channelling and removal of substances, including devices for dialysis, or
• at least 2 years of experience in design of Non-active non-implantable devices for administration, channelling and removal of substances, including devices for dialysis with FR training, carried out by NB
  
  

MDN 1203

Non-active non-implantable guide catheters, balloon catheters, guidewires, introducers, filters, and related tools

• 4 years in the field of medical devices or similar, of which possibly
• at least 2 years in NB with FR experience for catheters, or
• at least 2 years of experience in design of catheters with FR training carried out by NB
  
  

MDN 1211

Non-active non-implantable devices for disinfecting, cleaning and rinsing

• 4 years in the medical device sector or similar sector
• of which at least 2 years in design at manufacturers of non-active medical devices for disinfection and cleaning, or
• at least 2 years in NB with PR experience for non-active disinfection and cleaning devices.
  
  

Clinical Specialist

MDA 0201

Active non-implantable imaging devices utilising ionizing radiation

at least 2 years of clinical practice in the use of diagnostic imaging devices with ionising radiation (e.g. CT, X-ray, etc.)

MDA 0315

Software

at least 2 years of clinical practice in the use of stand-alone medical software

MDA 0306

Active non-implantable devices for extra-corporal circulation, administration or removal of substances and haemapheresis

at least 2 years of clinical practice in the use of devices for extra-corporal circulation, administration or removal of substances and haemapheresis

MDA 0307

Active non-implantable respirator devices

at least 2 years of clinical practice in the use of non-implantable respirator devices

MDA 0310

Active non-implantable devices for ear, nose and throat

at least 2 years of clinical practice in the use of devices for ear, nose and throat

MDA 0316

Medical gas supply systems and part thereof

at least 2 years of clinical practice in the use of devices for supply of medical gas

MDN 1201

Non active non-implantable devices for anaesthesia, emergency and intensive care

at least 2 years of clinical practice in the use of devices for anaesthesia, emergency and intensive care