Medical Devices Lead Auditor

3 weeks ago


Philippines SGS (Malaysia) Sdn Bhd Full time

Job Description

We have an excellent new opportunity fora Medical Device Lead Auditor to join our global organization.The successful candidate 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.

  • 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 SGS policies and accreditation/approval requirements.
  • Project manage auditing teams, as appropriate, to maximize efficiencies, enhance client satisfaction and ensure compliance with standards

Qualifications

To be considered for this role, you'll require a minimum of 4 years of professional experience in relevant field of healthcare products or related activities e.g.:

  • 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
  • 2 years of the 4 of relevant professional experience shall be in quality management. E.g. Quality Manager/Engineer, CAPA or complaint Manager/Engineer

Additional Information
  • An 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
  • 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 active and non-active devices
  • GCSE Mathematics & English Language (or equivalent)
  • University or technical college degree or equivalent qualification in relevant sciences such as: Medicine, Pharmacy, Chemistry, Biochemistry, Biology, Microbiology, Biotechnology, Health Technology, Toxicology, Physics, Biophysics, Material Science Biomedical Engineering, Mechanical, Electrical or Electronic Engineering, Computer & Software Technology, Human Physiology, Nursing, Quality Management.


  • Philippines, Quezon City Delex Pharma International, Inc. Full time

    Company DescriptionDelex Pharma International, Inc. is the 3rd largest in the hospital channel and an ISO 9001:2015-certified Filipino-owned pharma and medical device company with topnotch global partners. The company aims to bring quality and cost-effective medicines and medical devices to the service of the Filipino people.Role DescriptionThis is a...


  • Philippines MicroSourcing Full time

    Complaint escalation and production floor support:Complaint escalation: When Customer Service (CS) Representatives or Clinic Operations (CO) Representatives (see corresponding job profiles) need to escalate complaint related cases because they are unsure how to handle them, the Technical Support Specialist (along with the Cue onshore team) is one of the...

  • PUP Career Fest 2024

    3 weeks ago


    Philippines SGS (Malaysia) Sdn Bhd Full time

    Job DescriptionThis job ad is intended to all parties involved in the Career Fair.Open Positions:For Fresh Graduates: 1. Laboratory Analyst I (Licensed Chemist) (Makati, Batangas, Subic & Cebu) 3. Laboratory Analyst (Microbiology) - (Davao) 4. Research and Development Specialist (Chem and Micro) - MLAB 5. Laboratory Analyst II (Licensed Chemist) 6....

  • Medical Technologists

    3 weeks ago


    Philippines, Quezon City Sto. Domingo Diagnostic and Medical Center Corp. Full time

    Sto. Domingo Diagnostic and Medical Center Corp. is a leading healthcare provider dedicated to delivering exceptional patient care and promoting a healthy community. We pride ourselves on our commitment to excellence, innovation, and compassionate healthcare services.Job DescriptionWe are currently seeking licensed Medical Technologists to join our dynamic...


  • Philippines, Olongapo, Central Luzon CXG Full time

    We are looking for Freelance Merchandising Auditors based in 19 cities in Philippines who are keen on evaluating store & device conditions for a world-renowned tech company. See below the cities in which we are looking for auditors. If you know someone in the city who may be suited for this opportunity, please keep in touch and there will be a referral fee...


  • Philippines Monroe Consulting Group Full time

    Executive Search Firm Monroe Consulting Group Philippines is recruiting on behalf of a multinational Medical Device company. Our respected client is seeking a Segment Marketing Lead experienced in life science. S/he will work closely with Regional Segment Leads & Country Leader and play a strategic role in developing impactful marketing strategy that is...


  • Philippines Monroe Consulting Group Full time

    Executive Search Firm Monroe Consulting Group Philippines is recruiting on behalf of a multinational Medical Device company. Our respected client is seeking a Segment Marketing Lead experienced in life science. S/he will work closely with Regional Segment Leads & Country Leader and play a strategic role in developing impactful marketing strategy that is...

  • Junior Auditor

    2 weeks ago


    Manila, Philippines Atlanta Industries Inc. Full time

    Company DescriptionAtlanta Industries, Inc. is a leading manufacturer of high-grade industrial pipes and fittings in the Philippines. With a mission to be the most recognized brand in the Philippine plastic industry, Atlanta Industries applies the highest quality standards to satisfy customer requirements. The company continuously develops and produces new...

  • Internal Auditor

    3 weeks ago


    Philippines Christ's Commission Fellowship Full time

    As a Internal Auditor, you will play a key role in ensuring the organization's internal controls, processes, and financial systems are compliant, efficient, and effective. Your responsibilities will include leading audit engagements, identifying areas of improvement, and providing strategic recommendations to enhance the company's governance and risk...


  • Philippines, Taguig Analog Devices Full time

    Engineers at Analog Devices (ADI) solve some of the world's most complex engineering problems. To be able to do so with ease, they need access to the best IC design infrastructure available. We, the Engineering Enablement (EE) team at ADI, aim to do just that, by building the infrastructure and support required by ADI's design community. The Analog Devices...


  • Taguig, Philippines Conifer Health Solutions Full time

    The Auditor, Coding Quality conducts Initial Coding Quality Reviews (IQRs), Monthly Coding Quality Reviews (MQRs), Focused Quality Audits, and other ad hoc coding quality audits as requested to ensure hospital inpatient, outpatient , and profee claims, ICD-10-CM/PCS, and/or CPT codes were coded and billed in accordance with nationally recognized coding...

  • IMPEX Supervisor

    3 weeks ago


    Santo Tomas, Philippines John Clements Recruitment Inc. Full time

    Substantial experience in Triangular Shipment, PEZA permits, license processing, logistics, and warehousingSupervises the movement of products/equipment/material in and or out of the country by the organization's policy and procedure and comply with relevant local and international laws and processes.Supervises necessary documentation and online permit...


  • Philippines, Caraga, Butuan City Government of Butuan Full time

    Role DescriptionThis is a full-time on-site role located in Butuan for a PSO III with the equivalent position of Internal Auditor III. The Internal Auditor will assist the Financial Audit Head in finalizing Accounting and Recording Audit Scope; Lead the conduct of the Accounting and Recording audits and review the corresponding audit workpaper documentation;...


  • Quezon City, Philippines Pharmazel Inc. Full time

    Medical Representative ResponsibilitiesSelling the company's medications to doctors, pharmacists, and other relevant healthcare professionals.Scheduling appointments with doctors, pharmacists, and other healthcare professionals to promote company medications.Developing an in-depth understanding of company medications.Building and maintaining good business...

  • IT Auditor

    3 weeks ago


    Taguig, Philippines DigiPlus Interactive Corp Full time

    DigiPlus Interactive Corp. (formerly known as Leisure and Resorts World Corporation) is a publicly listed company (PSE: PLUS). With over 20 years of expertise under its belt, DigiPlus ushered its unbeatable dominance in the Philippine retail gaming market by forging an empire of world-class multi-gaming platforms strategically located through a robust...

  • Internal Auditor

    4 days ago


    Philippines, Taguig OwnBank Full time

    As an Internal Auditor, you'll be instrumental in ensuring the organization's internal controls, processes, and financial systems meet compliance standards and operate optimally. Your duties involve leading audit projects, pinpointing areas for enhancement, and offering strategic advice to boost the company's governance and risk management practices.Job...

  • Sales Engineer

    3 weeks ago


    Philippines, Quezon City One Top Medical Systems Resources Full time

    Company DescriptionOne Top Medical Systems Resources, formerly One Top Systems Resources, is a health and safety oriented company which aims to provide the most advanced and innovative technologies related to its industry in the Philippines. We concentrate our resources on two main tiers, health technology and safety systems.Role DescriptionThis is a...


  • Philippines Business Innovations Gateway Inc. Full time

    Responsibilities Promoting and selling company health products, specifically medications, to doctors, pharmacists, and other relevant healthcare professionals within Ethical Operations such as hospitals, doctors' clinics, etc. Scheduling appointments with doctors, pharmacists, and other healthcare professionals to present and promote company medications....


  • Philippines Vector Outsourcing Solutions Philippines Full time

    Salary: 50,000 PHP- 70,000/ monthJob Description:Supervise and lead a team of medical billing specialists, providing guidance, training, and support as needed.Communicate and facilitate special projects, reports, and requests from clientAssign tasks, set priorities, and monitor performance to ensure productivity and accuracy.Develop and improve billing...

  • Internal Auditor

    4 days ago


    Philippines Maxeon Full time

    Powering Positive Change™Join Our Team at Maxeon: Internal Auditor- Where Innovation Meets SustainabilityWho We Are: Pioneers in Solar Energy at Maxeon, we're not just harnessing the power of the sun, we're leading a global energy revolution. Our mission To champion solar energy for a sustainable future. In a world of constant change, the only way to make...