Medical Device QMS Audit Manager
6 giorni fa
We are seeking a knowledgeable and driven Medical Device QMS Audit Manager to lead and oversee the training qualification and compliance processes for QMS Auditors involved in our medical device conformity assessments. This non-clinical role plays a vital part in ensuring the competence of technical personnel and the continued regulatory compliance of SGS Notified Body 1639. Your Mission As Technical Team Manager you will : Lead the development and delivery of training and qualification frameworks for technical staff (excluding clinical). Establish and maintain competence criteria, monitor qualification status and approve audit and assessment activities. Provide expert technical guidance across the entire conformity assessment process and contribute to the development of QMS documentation aligned with EU regulations and best practices. Support operational technical and strategic initiatives to maintain the integrity and effectiveness of SGS medical device services. Work closely with the Medical Devices Management Team to stay abreast of regulatory changes and align internal processes accordingly. Key Responsibilities Design and manage training programs for QMS Auditors globally. Approve Level 1 audits and witness audits for auditor qualification and requalification. Contribute to recruitment onboarding and approval of new personnel. Develop and maintain QMS documentation aligned with MDR IVDR NBOG and MDCG guidance. Ensure competence compliance and operational efficiency across assessment teams. Provide technical support across SGS NB 1639 activities and contribute to business development. Qualifications Education : Bachelors degree (or equivalent) in medicine, pharmacy, engineering or related scientific field. Experience:10 years in the medical device industry including at least 5 years in R&D or manufacturing roles. Minimum 4 years working within a Notified Body. Minimum 2 years leadership experience. Prior qualification as a Lead Auditor under MDR and / or IVDR. Strong background in QMS auditing, technical file assessment and applicable standards (ISO 13485, ISO 14971, etc.). Skills:Deep technical knowledge of non-clinical aspects of medical device conformity assessment. Proven ability to develop and deliver effective training. Strong understanding of EU regulatory frameworks and best practice guidance. Excellent stakeholder engagement, problem-solving and communication skills. Additional Information Why SGS Opportunity to work with a global leader in inspection, verification, testing and certification. Collaborative and inclusive work environment. Competitive salary and benefits package. Opportunities for professional growth and development. Join Us : At SGS we are dedicated to fostering an open, friendly and supportive culture that thrives on teamwork. We value diversity and provide endless opportunities to learn, grow your expertise and fulfil your potential. Remote Work : Yes Employment Type : Full-time Key Skills Auditing, GAAP, Accounting, Research Experience, SOX, Project Management, Customer relationship management, Financial Report Interpretation, Internal Audits, Mentoring, Supervising Experience, GAAS Experience : years Vacancy : 1 #J-18808-Ljbffr
-
Medical Device QMS Audit Manager
1 settimana fa
WorkFromHome, Italia SGS A tempo pienoCompany Description and Location: SGS is the world’s leading testing, inspection and certification company, recognised as the global benchmark for sustainability, quality and integrity. 44,000 employees operate 2,500 offices and laboratories worldwide, enabling a safer and more interconnected world. The role is Remote within Europe. We are seeking a...
-
Remote Medical Device QMS Audit Lead
6 giorni fa
WorkFromHome, Italia SGS A tempo pienoA global leader in inspection and certification is seeking a knowledgeable Medical Device QMS Audit Manager to oversee training and compliance for QMS Auditors. You will develop training frameworks and ensure qualification criteria are met while providing expert guidance across conformity assessments. Ideal candidates will have 10+ years of experience in the...
-
Global Head, Medical Device Commercial
2 settimane fa
WorkFromHome, Italia SGS A tempo pienoA leading global testing company is seeking a Mid-Senior Level Business Development professional to lead their global sales strategy within medical devices. You will be responsible for driving the development of medical schemes, enhancing client engagement, and securing competitive pricing strategies. The ideal candidate has over 5 years of experience in the...
-
Clinical Project Manager – European Medical Device Studies
2 settimane fa
WorkFromHome, Italia BD A tempo pienoClinical Project Manager – European Medical Device Studies Join to apply for the Clinical Project Manager – European Medical Device Studies role at BD Job Description Summary Are you ready to combine your expertise in clinical research with your talent for project leadership? Join our European Clinical Affairs team and play a pivotal role in advancing...
-
Remote Medical Device QA
2 giorni fa
WorkFromHome, Italia SGS A tempo pienoA leading global testing and certification company is seeking a Quality Assurance professional for a remote position focused on managing the internal quality management system for medical devices. Responsibilities include updating and maintaining compliance documents, managing queries, and supporting continual improvement processes. Candidates should have a...
-
Remote QA Officer
1 settimana fa
WorkFromHome, Italia SGS A tempo pienoA global leader in TIC is seeking a Quality Assurance Specialist to manage the internal quality management system for medical devices. Responsibilities include updating compliance documents, managing complaints, and ensuring adherence to quality standards. Ideal candidates should have a strong background in quality management systems and relevant educational...
-
Remote: Global Head of Medical Device Growth
2 settimane fa
WorkFromHome, Italia SGS A tempo pienoA leading testing and certification company in Milan is seeking an experienced professional to lead the global sales strategy for medical devices. This role involves managing complex projects, fostering business growth, and collaborating with various stakeholders. The ideal candidate has over 5 years of experience in sales within the medical device industry...
-
Regulatory Manager
1 settimana fa
WorkFromHome, Italia SGS A tempo pienoOverview We are seeking a highly skilled Regulatory Manager to oversee the clinical and performance evaluation components of our medical device conformity assessment process within Notified Body 1639. This role is vital to ensuring regulatory excellence, clinical integrity and the delivery of high-quality assessments aligned with MDR and IVDR. Your Mission...
-
Regulatory Manager
2 settimane fa
WorkFromHome, Italia SGS A tempo pienoOverview We are seeking a highly skilled Regulatory Manager to oversee the clinical and performance evaluation components of our medical device conformity assessment process within Notified Body 1639. This role is vital to ensuring regulatory excellence, clinical integrity and the delivery of high-quality assessments aligned with MDR and IVDR. Your Mission...
-
Quality Assurance Officer
1 settimana fa
WorkFromHome, Italia SGS A tempo pienoMain Purpose of Role : Maintenance of the NB 1639 medical device internal quality management system. Managing of daily QA tasks Updating and maintenance of documents under the MDD MDR and IVDR scheme Management the IF database Collaboration on generic scheme documents Publishing of documents on the SGS website Bizzmine (Quality Management System); user...
