lead auditor - Medical DevicesThe VITO Group

Our client:
A global leader in testing and certification
JOB SUMMARY: The Medical Device Lead Auditor will be responsible for planning and conducting audits against the manufacturing of medical devices, in accordance with ISO 13485, MDD 93/42/EEC, and MDSAP standards, enabling the delivery of assessment and certification services that meet customer requirements and appropriate accreditation standards.
RESPONSIBILITIES:
Conduct audits (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 company policies and accreditation/approval requirements.
Project manage auditing teams, as appropriate, to maximize efficiencies, enhance client satisfaction and ensure compliance with standards
QUALIFICATIONS:
Bachelor's degree in sciences or medical related fields
Minimum of 4 years of professional experience in relevant fields of healthcare products or related activities such as:
Work in medical devices industry or closely related industries (e.g. pharmaceutical industry) such as research and development, manufacturing, quality management, regulatory affairs
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 with the relevant national or international standards
Conducting performance testing, evaluation studies or clinical trials of devices
Minimum of 2 years professional experience shall be in quality management, e.g. Quality Manager/Engineer, CAPA or complaint Manager/Engineer
Excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques
Good knowledge of ISO 13485, MDD 93/42/EEC and their application
Knowledge of MDR 2017/745, MDSAP
Work experience in positions with significant QA, Regulatory or management systems responsibility
Experience with harmonized medical device standards and for active & non active devices.
Experience with Risk Management EN ISO 14971
Registered IRCA lead auditor, or equivalent registration under other recognized body, is preferable
The VITO Group

Makati City, Metro Manila
₱40,000-45,000 per month
Permanent
Full-time