Medical Device Assessors & Lead Auditors - Active Device

DNV; Hamburg; Vor Ort; EUR 50.000 - 80.000; Vollzeit

Zusammenfassung

A leading company in the field of medical device assurance is seeking an Active Medical Device Assessor / Lead Auditor. You will be responsible for planning and conducting audits in accordance with established medical device standards. This role requires a technical degree and several years of experience in the industry. Candidates will engage in challenging projects alongside a professional community dedicated to quality and integrity.

Leistungen

Competitive compensation and benefit package

Training and qualification program

Professional community in a prestigious company

Qualifikationen

• Minimum 4 years' experience in medical device industry.
• Experience with ISO 13485, MDD, MDR standards required.
• Knowledge of sterilization techniques is desirable.

Aufgaben

• Conduct assessments and ensure regulatory compliance.
• Review Technical Files for medical devices.
• Project manage auditing teams to enhance client satisfaction.

Kenntnisse

Risk Management

Technical Writing

Quality Assurance

Auditing Techniques

Biological Safety

Medical Device Compliance

Ausbildung

Technical College Degree in Relevant Area

Jobbeschreibung

Overview

About us

We are the independent expert in assurance and risk management. Driven by our purpose, to safeguard life, property, and the environment, we empower our customers and their stakeholders with facts and reliable insights so that critical decisions can be made with confidence.

As a trusted voice for many of the world's most successful organizations, we use our knowledge to advance safety and performance, set industry benchmarks, and inspire and invent solutions to tackle global transformations.

About SCPA

We help our customers respond to the increased demand for trust and transparency around products, assets, supply chains, and ecosystems, driving the transformation of the assurance industry. Whether certifying products, sharing 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. Drawing on our wide technical and industry expertise, we work with companies worldwide to bridge trust gaps among consumers, producers and suppliers.
About the role

DNV is a global leader and innovator in inspection, verification, testing and certification services. Founded in 1864, DNV is recognized as the global benchmark in quality and integrity. We encourage new ideas, we welcome people who challenge the way we do things, and we will be 100% committed to helping you reach your full potential.

DNV Product Assurance AS is an accredited Certification Body and MDR approved Notified Body for Medical Devices and Hazardous Area Equipment. We provide global market access by testing and 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.

As part of our continued growth, we are looking to recruit a technical and experienced Active Medical Device Assessor / Lead Auditor in Europe. The successful candidate will be responsible for planning and conducting audits / assessments 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.

Key Accountabilities:
• Conduct assessments (either desk-based or on client's sites) in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer relationships.
• Conduct Technical File reviews specific for products being authorized.
• Complete all chargeable work within the required budget and timeframes to ensure customer satisfaction and efficiency of the business.
• Complete specific projects in relation to medical device procedures, processes, systems and documentation as requested by the Medical Devices Operations Manager.
• If required, undertake reviews of packs and make certification decisions within target timescales and in line with DNV policies and accreditation/approval requirements.
• Project manage auditing teams, as appropriate, to maximize efficiencies, enhance client satisfaction and ensure compliance with standards.

Please note that for candidates with employment history in Germany we cannot proceed to the interview stage without the following documents: Curriculum Vitae (CV); Cover- /Motivation Letter; University Diplomas & Transcripts; Reference Letter(s). All documents shall preferably be submitted in English. Please provide them at your earliest convenience to ensure a smooth and timely assessment process. Your cooperation in this matter is greatly appreciated.

What we offer

• A competitive compensation and benefit package
• DNV training and qualification program
• A professional community in a prestigious technological company
• Possibilities to work with interesting and challenging projects
• Access to an extensive competence network
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.
About you

Position Qualifications:
Assessor / Auditor shall have a technical college degree in a relevant product or medical area, as described below.

Active devices
• Computer and Software Technology
• Electrical, Electronic, Mechanical or Bioengineering
• Medical Technology
In addition to a relevant educational degree, the candidate must have a minimum 4 years' work experience (full time) in a medical device related industry, with at least 2 of these years in the design, manufacturing, testing or use of the device in which they are qualified to Audit / Assess, and/or experience as an assessor in a notified body (full five technical documentation assessments).

As part of this work experience, risk management experience should be covered:
• Practical experience in conducting pre-clinical testing or assessing preclinical data with medical devices in one or more of the following areas such as biological safety, physical, chemical and microbiological characterization, stability, shelf life, performance and safety
A PhD in a relevant area for medical devices can substitute 3 years of work experience provided it includes 2 years' experience in design, manufacture or testing.

To be considered for this role, you will have professional experience in a relevant field of healthcare products or related activities, for example:
• Work in medical devices industry or closely related industries (e.g. pharmaceutical industry) in a research and development, manufacturing, quality management or regulatory affairs capacity
• Work in health services, universities, foundations or other institutions carrying out inspections, audits, clinical evaluations, experimental and/or clinical research, including notified bodies
• Work in the application of device technology and its use in health care services and with patients
• Testing devices for compliance in accordance to the relevant national or international standards
• Conducting performance testing, evaluation studies or clinical trials of devices
• Programming (Software) experience would be beneficial
In addition to the above you'll also need to demonstrate the following;
• An excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques
• Work experience in positions with significant QA Regulatory or management systems responsibility
• Experience with Harmonized medical device standards for active & non active medical devices
• Experience with Risk Management EN ISO 14971
• Experience with Sterilization techniques (such as ETO, Gamma, Steam, Dry Heat) and formal qualification desirable
• Medical device experience from auditing/work
• Experience auditing against recognized standards
• Experience of working under own initiative and in planning and prioritizing workloads
• Solid knowledge of medical devices
• Should have a flair for technical writing, essential for exhaustive report writing

If you're interested in applying, please submit your CV in English.

Kindly be informed you may be requested to provide DNV with additional documents for a background check.

You will be hired on local conditions.

Interviews will be held on an on-going basis.

What we offer

• A competitive compensation and benefit package
• DNV training and qualification program
• A professional community in a prestigious technological company
• Possibilities to work with interesting and challenging projects
• Access to an extensive competence network
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.

About you

Position Qualifications:
Assessor / Auditor shall have a technical college degree in a relevant product or medical area, as described below.

Active devices
• Computer and Software Technology
• Electrical, Electronic, Mechanical or Bioengineering
• Medical Technology
In addition to a relevant educational degree, the candidate must have a minimum 4 years' work experience (full time) in a medical device related industry, with at least 2 of these years in the design, manufacturing, testing or use of the device in which they are qualified to Audit / Assess, and/or experience as an assessor in a notified body (full five technical documentation assessments).

As part of this work experience, risk management experience should be covered:
• Practical experience in conducting pre-clinical testing or assessing preclinical data with medical devices in one or more of the following areas such as biological safety, physical, chemical and microbiological characterization, stability, shelf life, performance and safety
A PhD in a relevant area for medical devices can substitute 3 years of work experience provided it includes 2 years' experience in design, manufacture or testing.

To be considered for this role, you will have professional experience in a relevant field of healthcare products or related activities, for example:
• Work in medical devices industry or closely related industries (e.g. pharmaceutical industry) in a research and development, manufacturing, quality management or regulatory affairs capacity
• Work in health services, universities, foundations or other institutions carrying out inspections, audits, clinical evaluations, experimental and/or clinical research, including notified bodies
• Work in the application of device technology and its use in health care services and with patients
• Testing devices for compliance in accordance to the relevant national or international standards
• Conducting performance testing, evaluation studies or clinical trials of devices
• Programming (Software) experience would be beneficial
In addition to the above you'll also need to demonstrate the following;
• An excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques
• Work experience in positions with significant QA Regulatory or management systems responsibility
• Experience with Harmonized medical device standards for active & non active medical devices
• Experience with Risk Management EN ISO 14971
• Experience with Sterilization techniques (such as ETO, Gamma, Steam, Dry Heat) and formal qualification desirable
• Medical device experience from auditing/work
• Experience auditing against recognized standards
• Experience of working under own initiative and in planning and prioritizing workloads
• Solid knowledge of medical devices
• Should have a flair for technical writing, essential for exhaustive report writing

If you're interested in applying, please submit your CV in English.

Kindly be informed you may be requested to provide DNV with additional documents for a background check.

You will be hired on local conditions.

Interviews will be held on an on-going basis.