Lead Auditors - Active & Non-active - Medical Devices - MEDCERT

Location DE-Hamburg | DE-Essen
Requisition ID
2023-21330
Business Area
Supply Chain & Product Assurance
Category/Discipline
Auditing
Posting Position Type
Permanent Employee

Local Unit & Position Description

MEDCERT is an accredited Certification Body for ISO 13485, recognised auditing organization under MDSAP and approved Notified Body for Medical Devices Regulation. We provide global market access by certifying the safety and quality of products and systems to international safety and quality standards and regulations. Our high professional standards and our sustainable approach guarantee you a forward-thinking work environment, within an organisation that invests in its employees, and is committed to providing you with continued development.

 

Medical Devices – Product Assurance

 

The production of medical devices is a strictly regulated business. MEDCERT is a Notified Body, providing services that secure our customers’ market access around the world. We assist the industry in ensuring medical devices are safe, effective and of the highest standard and quality.

 

We are expanding our team and now seeking Lead Auditors for Active & Non-active Medical Devices on either a full-time or freelance basis. The successful candidates will be responsible for planning and conducting audits against the manufacturing of medical devices, in accordance with ISO 13485, MDD 93/42/EEC, MDR 745/2017 and MDSAP standards, enabling the delivery of assessment and certification services that meet customer requirements and appropriate accreditation standards.

 

Your primary tasks will include:

 

  • Planning and conducting audits (locally & internationally) with the aim of ensuring product and management system compliance
  • Ensuring that audits are conducted in a competent way and within requirements from authorities, leading to satisfied customers.

Position Qualifications

  • Bachelor or master Pharmaceutical/Science/Engineering
  • At least 4 years working experience in one of the following areas: development, manufacturing, testing, and/or application of medical devices
  • Knowledge of quality management system certification and regulatory requirements within CE-marking
  • Knowledge in relation to external supplier audits/internal audits
  • Fluent in English and German language, both spoken and written

Competency Requirements:

  • Structured, able to take initiative and work independently as well as part of a team
  • Good communication skills and customer focus
  • Ability to cope with a dynamic and changing environment
  • Strong software skills (Microsoft Office)
  • Cross cultural collaboration

Interviews will be held on an ongoing basis.

Company & Business Area Description

DNV is an independent assurance and risk management provider, operating in more than 100 countries. Through assessment and digital assurance solutions, DNV helps companies build trust and transparency around products, assets, supply chains and ecosystems. 

Whether certifying products, verifying claims or optimizing and decarbonizing supply chains, DNV helps companies manage risks and realize their long-term strategic goals, improving ESG performance and generating lasting, sustainable results. 

Combining sustainability, supply chain and digital expertise, DNV works to create new assurance models enabling interaction and transaction transparency across value chains. Drawing on our wide technical and industry expertise, we work with companies worldwide to bridge trust gaps among consumers, producers and suppliers.

Driven by its purpose, to safeguard life, property, and the environment, DNV helps tackle the challenges and global transformations facing its customers and the world today and is a trusted voice for many of the world’s most successful and forward-thinking companies.

Equal Opportunity Statement

DNV is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to gender, religion, race, national or ethnic origin, cultural background, social group, disability, sexual orientation, gender identity, marital status, age or political opinion. Diversity is fundamental to our culture and we invite you to be part of this diversity!

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