Work with us

Recognized all over the world, Ente Certificazione Macchine is a market leader because we put 100% of passion, commitment and innovation in everything we do. ECM is a company founded on work and skills, which is why our staff represents the driving force behind the company’s success.

The ability to hire and grow talent is a fundamental goal for us.

We encourage new ideas and welcome people who stimulate the way we do. Through our diversified and international business, you can learn about and increase ECM’s know-how, helping to transmit our values ​​and at the same time achieve personal and shared goals.

If you want to get in touch with our reality, apply for one of the Open Positions or send us your Curriculum Vitae.

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Open Positions

Ad title Place of work Job type Type of contract Publication date Job position description Apply
Auditor and Technical File Reviewer USA Full time Freelance 15/04/2026 Read detail

Auditor and Technical File Reviewer

Ente Certificazione Macchine, a European Notified Body No. 1282 for Regulation (EU) 2017/745 (MDR) and other European product directives.

ECM is seeking qualified freelance professionals based in the USA (preferably West Coast) for the combined role of Auditor and Technical File Reviewer (under Regulation (EU) 2017/745), who have gained significant experience in the same role(s) within other Notified Bodies.

 

Key Responsibilities

  • Conduct audits at manufacturers and suppliers’ sites, in the USA and LATAM
    • Codes of interest for the role of auditor:

MDS1009, MDS1010, MDT2010

  • Review technical documentation of assigned medical devices, assessing compliance with Regulation (EU) 2017/745
    • Codes of interest for the role of Technical File Reviewer:

MDA0202, MDA0203, MDA0204, MDA0302, MDA0303, MDA0305, MDA0306, MDA0307, MDA0308, MDA0312, MDA0313, MDA0315, MDA0317, MDA0318, MDS1009, MDS1010

  • Manage certification procedures for an international portfolio of active medical device manufacturers

Mandatory Requirements

  • University degree in relevant disciplines (e.g. medicine, pharmacy, engineering or other relevant sciences).
  • The candidate has not offered or provided within the last three years, consultancy services in relation to the design, manufacturing, marketing, or maintenance of medical devices or regarding specific quality management system processes.
  • Having carried out at least five Stage 2 or surveillance audits (according to MDR UE 2017/745, or MDD 93/42, or ISO13485) at another Notified Body or Certification Assessment Body, for a minimum of 8 man-days.
  • Evaluation activities of at least 5 complete FT/DT (Technical Files) for each code at the Notified Body, in the role of Technical File Reviewer

This position is open to applicants of all genders.
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Auditor and Technical File Reviewer

Accreditation Manager Valsamoggia (BO) full time To be defined 31/03/2026 Read detail

Accreditation Manager

Ente Certificazione Macchine – Notified Body No. 1282 – is seeking an Accreditation Manager with specific experience in the ISO/IEC 17065 standard. The selected candidate will be responsible for:

  • Maintaining current accreditations.

  • Securing new accreditations.

  • Implementing and updating the quality system and internal procedures.

  • Managing relationships with regulatory and supervisory authorities.

SKILLS AND REQUIREMENTS

  • Experience: Several years of experience in a similar role.

  • Education: Degree in Engineering or a Technical Diploma (Electrotechnical, Mechanical, or Electronic).

  • Technical Knowledge: In-depth knowledge of the ISO/IEC 17065 standard.

  • Languages: Good command of English and excellent command of Italian.

  • Travel: Availability for occasional domestic and international travel.

LOCATION

The work will be performed on-site at the ECM headquarters in Valsamoggia (BO), with occasional travel to client sites.

This position is open to applicants of all genders.
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Accreditation Manager
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