- As the Medical Device Lead Auditor, you will perform third-party audits per SGS Certification procedures and the requirements for ISO 13485, MDSAP, MDD and MDR standards.
- The Medical Device Lead Auditor is responsible to make relevant decisions concerning the audit process and to inform SGS as required to resolve issues outside the audit process.
- The Medical Device Lead Auditor is responsible to collect and analyze sufficient information to provide a recommendation for certification.
- The Medical Device Lead Auditor has the authority for the control and performance of auditing activities including planning and the control of other members of audit teams.
- Perform audits for clients' medical devices quality management systems and technical information to the requirements of ISO 13485 and other regulatory requirements such as MDSAP, MDD and MDR.
- To control as necessary, teams of auditors during the activities covered by items above.
- Decide upon evidence gained during audits whether or not registration should be recommended or allowed to continue.
- Strive to acquire sufficient audit experience to cover the whole of SGS's Certification's accredited activities.
- Assist in the training of other auditors and lead auditors during planned audits or during other training functions.
- Participate actively in witness audits by SGS or accreditation bodies.
- Maintain all audit credentials.
- Undertake any other activities as directed by the Operations and/or Accreditation Manager.
- As a Lead auditor you are responsible for the overall audit team.
- Adheres to internal standards, policies, and procedures and performs other duties as assigned.
- University or technical college degree in a related discipline (, Medicine, Pharmacology, Biomedical engineering, Microbiology, Biotechnology, Biochemistry, Health technology, Mechanical engineering, Electronical engineering, Quality Management etc.)
- At least 4 years of experience in the medical device industry
- Experience auditing for ISO 13485, MDSAP, MDD and MDR standards.
- Auditor Credentials for either of these standards: ISO 13485, MDSAP, MDD and MDR
- Ability to demonstrate an excellent working knowledge of medical device management and regulatory systems, standards and compliance/auditing techniques
- Detailed understanding of the relevant medical device regulations for which audits reviews are being undertaken
- Effective interpersonal skills; able to develop good working relationships with people at all levels, verbal, written and presentation skills
- Leadership abilities – ability to Lead a team to achieve a set up goal or complete an audit on time and according to standards
- Proactive attitude and excellent organizational skills
- Effectively reacts in stressful situations and make clear, well-founded decisions regarding conformity during the audit
- Ability to multitask and manage multiple projects while delivering results on time
- Act with integrity, tact, and character
- Willingness to learn and adapt to change – committed to continuous personal and professional development
- Must be IT literate , competent in the use of MS Office applications and preferable experience of using large and complex databases
- Has working knowledge of English language as well as German
-
Medical Device Lead Auditor
Gefunden in: beBee S2 CH - vor 2 Tagen
SGS SA Zürich, Schweiz GanztagsSGS is the world's leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 97'000 employees, SGS operates a network of over 2 650 offices and laboratories around the world. · Primary ...
-
Group Internal Auditor and Data Analytics Lead
Gefunden in: Talent CH C2 - vor 3 Tagen
Aryzta AG Schlieren, SchweizCompany Overview · Swiss-based Aryzta is an international food business with a leading position in frozen B2B bakery business in Europe and APAC. Aryzta's customer channels consist of grocery, convenience, quick service restaurants, bakeries and foodservice. Listed on the Swiss ...
-
Group Internal Auditor and Data Analytics Lead
Gefunden in: Talent CH C2 - vor 3 Tagen
ARYZTA Careers Schlieren, SchweizCompany Overview · Swiss-based Aryzta is an international food business with a leading position in frozen B2B bakery business in Europe and APAC. Aryzta's customer channels consist of grocery, convenience, quick service restaurants, bakeries and foodservice. Listed on the Swiss s ...
-
Cyber-Security-Berater/in Datenschutz 80–100%
Gefunden in: Talent CH A C2 - vor 1 Tag
Kanton Zürich, Behörden Datenschutzbeauftragte Zürich, SchweizIhre Aufgaben · Beraten im Bereich der organisatorischen und technischen Informationssicherheit · Überprüfen von Informationssicherheitskonzepten aus den unterschiedlichsten Projekten und Organisationen · Durchführen von Audits (Datenschutzreviews) · Verfassen von Stellungnahmen ...
-
Security Consultant Public Sector 80-100%
Gefunden in: Jobcloud CH C2 - vor 14 Stunden
Jobcloud Zürich, SchweizDas wirst du tun · Für die Verstärkung unseres dynamischen Security Solutions Teams in unserer Market Unit Public Sector suchen wir eine*n erfahrene*n Senior Security Consultant (Teilzeit möglich). Bist du von der Informationssicherheit in all ihren Facetten genauso fasziniert wi ...
-
IT Auditor
Gefunden in: Talent CH C2 - vor 6 Tagen
coni+partner AG Zürich, Schweiz CDIconi + partner ist ein seit 1993 bestehendes Beratungshaus mit Sitz in Zürich und Niederlassungen in Düsseldorf und Shanghai. Unsere Stärke ist die passgenaue Besetzung von Positionen entsprechend der Unternehmenskultur, unter genauer Betrachtung fachlicher Kompetenzen, Referenze ...
-
IT Auditor
Gefunden in: Talent CH C2 - vor 3 Tagen
coni+partner AG Zurich, Schweiz CDIconi + partner ist ein seit 1993 bestehendes Beratungshaus mit Sitz in Zürich und Niederlassungen in Düsseldorf und Shanghai. Unsere Stärke ist die passgenaue Besetzung von Positionen entsprechend der Unternehmenskultur, unter genauer Betrachtung fachlicher Kompetenzen, Referenze ...
-
Contractor - Retail & Hospitality Auditor (Switzerland)
Gefunden in: Talent CH C2 - vor 6 Tagen
LRQA Zürich, Schweiz ContractJob ID: · Location:[[location_obj]] · Position Category:Assessors · Position Type:Contractor On Demand · For this position, you will need to be located in Switzerland and ideally we are looking for people living in Zurich. However, any areas wil be considered as we are looking f ...
-
Team Lead Identity
Gefunden in: Talent CH C2 - vor 2 Tagen
Zürcher Kantonalbank Zürich, SchweizTeam Lead Identity & Access Management (w/m/d) 100% | IT / Business Engineering | Zürich | Berufserfahrene mit Personalverantwortung Mit deinem Team, bestehend aus 10 Personen, gestaltest du die Zukunft des firmenweiten Identity & Access Managements. Dieses erfährt durch Cloud-I ...
-
Head Of Internal Audit
Gefunden in: Jobsch CH C2 - vor 3 Tagen
Robert Walters Switzerland Zürich, SchweizThis opportunity is for someone looking to have a hands-on approach and able to work in a very dynamic environment, managing a team located across different time zones. If you are looking to truly help and shape the business, this is the right challenge for you. · Please use the ...
-
Cfo
Gefunden in: Jobsch CH C2 - vor 4 Tagen
RaiseNow AG Zürich, SchweizPlease note: This position can be occupied in Zurich or completely remote in Switzerland. Part-time scope possible: at least 80% · Your mission · You are an effective business partner to the CEO and COO, give advice and counsel as well as provide a voice of reason. We want you to ...
-
Legal, Wealth Management Analyst
Gefunden in: One Red Cent EUR eFC C2 - vor 2 Tagen
Goldman Sachs Zurich, Schweiz GanztagsTHE LEGAL DIVISION · We work at the intersection of finance and law, providing counsel and advice that support activities across the firm. We handle litigation and arbitration, perform research and due diligence, aid in financing and legal filings, deal with contracts and intell ...
-
Senior Mandarin-Speaking Internal Auditor
Gefunden in: Talent CH C2 - vor 2 Tagen
coni+partner AG Zürich, Schweiz CDIconi + partner, established 1993, is a consultancy company with headquarters in Zurich and subsidiaries in Düsseldorf and Shanghai. We are specialised in custom-fit staffing in tune with the corporate culture by ensuring a perfect match of professional skills, references and pers ...
-
Freelance Auditor Sustainability
Gefunden in: Talent CH C2 - vor 3 Tagen
SGS Zürich, Schweiz GanztagsUnternehmensbeschreibung · We are the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories around the world. Wh ...
-
Audit Career Start
Gefunden in: Talent CH C2 - vor 5 Tagen
BDO Zürich, SchweizAudit Career Start - October % (w/m/d) · Zürich · Wirtschaftsprüfung · WE'RE BDO. AN ACCOUNTANCY AND BUSINESS ADVISORY FIRM, PROVIDING THE ADVICE AND SOLUTIONS BUSINESSES NEED TO NAVIGATE TODAY'S CHANGING WORLD. · The international entrepreneurial businesses we work with are Sw ...
-
Chief Information Security Officer
Gefunden in: Talent CH C2 - vor 1 Tag
RULEMATCH AG Zürich, Schweiz CDIRULEMATCH is a digital assets trading and clearing venue with world-class partners to meet the specific needs of regulated financial institutions. By offering significantly more capital-efficient and lower latency trading, RULEMATCH is helping increase institutional adoption and ...
-
Senior Legal Counsel
Gefunden in: Talent CH C2 - vor 1 Tag
RULEMATCH AG Zurich, Schweiz CDIRULEMATCH has built a digital assets trading and clearing venue with world-class partners to meet the specific needs of regulated financial institutions. By offering significantly more capital-efficient and lower latency trading, RULEMATCH is helping increase institutional adopti ...
-
Information Security
Gefunden in: beBee S2 CH - vor 3 Tagen
Viseca Payment Services AG CH- Zürich, Schweiz NebenberuflichInformation Security & IT Risk Manager 80-100% · Möchtest Du gemeinsam mit uns die Zukunft des bargeldlosen Bezahlens in der Schweiz gestalten? Fühlst Du Dich wohl in einem dynamischen und unkomplizierten Unternehmen? Dann freuen wir uns darauf, dich kennenzulernen · Als Verstärk ...
-
Cloud Security Consultant
Gefunden in: beBee S2 CH - vor 6 Tagen
FortIT AG CH- Zürich, Schweiz GanztagsDu hast eine Leidenschaft für Cyber Security? Komm in unser Team und werde ein Experte für Cyber Security und Cloud Security. Du wirst Cyber Security Risiken identifizieren und unseren Kunden helfen, ihre digitalen Werte und Prozesse zu schützen um die Resilienz ihres Unternehmen ...
-
CFO (f/x/m)
Gefunden in: Talent CH C2 - vor 5 Tagen
RaiseNow AG Zürich, Schweiz CDIThis is what it's about · Please note: This position can be occupied in Zurich or completely remote in Switzerland. Part-time scope possible: at least 80% · You want to play a key role in shaping business plans, funding rounds and internal processes to drive the growth of RaiseN ...
Medical Device Lead Auditor - Zürich, Schweiz - SGS
Beschreibung
Job Description
Primary Responsibilities
Specific Responsibilities
Qualifications