Medical Device ISO13485 auditor assessor(homebased)

BSI Group; Singapore; Hybrid; SGD 70,000 - 90,000; Full time

Job summary

A leading standards organization is seeking a Medical Device Assessor in Singapore to conduct audits for medical device manufacturers across the APAC region. The ideal candidate has at least 4 years of accountability in design, testing, or manufacturing of medical devices, along with a relevant degree. Responsibilities include auditing ISO 13485 systems and writing detailed reports. This position requires fluency in English and the ability to travel frequently across the region.

Qualifications

• Four or more years in medical device accountability.
• Experience with active medical device research and development preferred.
• Degree in chemistry, biology or related field is required.
• At least two years in an environment with a Quality Management System.
• Fluency in English is mandatory.

Responsibilities

• Conduct ISO 13485 audits, both on-site and remotely.
• Participate in training for Lead Auditor and compliance assessments.
• Prepare reports from audit findings and manage scheduling.

Skills

ISO 13485 quality management

Medical device R&D

English fluency

Design and testing of medical devices

Resilience and adaptability

Education

Degree in relevant field

Job description

We exist to create positive change for people and the planet. Join us and make a difference too!

Medical Device Assessor

Singapore home-based travel required local hire

As a Medical Device Auditor you’ll travel to medical device manufacturers across APAC. You’ll help these manufacturers to improve their performance by assessing their ISO 13485 quality management system so they can ensure patient safety and comply with regulatory procedures.

Responsibilities

• In the first six months: receive training in ISO 13485 Lead Auditor training, MDSAP and MDR. Initially observe audits and then conduct them on site and remotely.
• In a typical week after training: conduct an audit on site or remotely; write up reports and liaise with the planning team to manage your audit schedule; continue development of MDR and advocate for the ISO 13485 APAC Delivery Team.

To thrive in this career you must:

• Have 4+ years being directly accountable for design, testing, or manufacturing of medical devices.
• Experience with active medical device R&D (software experience preferred).
• Have a degree relevant to medical devices (chemistry, physical chemistry, molecular genetics, textiles, material science, biology, biotechnology or similar).
• Have at least 2 years experience working in an environment with a Quality Management System established.
• Be able to speak and write fluently in English.
• Be resilient and able to travel frequently across the APAC region.
• Hold Singapore EP or Singapore citizenship required.

We’re enthusiastic to receive applications from those based in Malaysia excited by this career opportunity.

About Us

BSI is a business improvement and standards company and for over a century BSI has been recognized for having a positive impact on organizations and society, building trust and enhancing lives. Today BSI partners with more than 77,500 clients in 195 countries and engages with a 15,000 strong global community of experts, industry and consumer groups, organizations and governments. Utilizing its extensive expertise in key industry sectors—including automotive, aerospace, built environment, food and retail and healthcare—BSI delivers on its purpose by helping its clients fulfil theirs. Living by our core values of Client-Centricity, Agility and Collaboration, BSI provides organizations with the confidence to grow by partnering with them to tackle society’s critical issues from climate change to building trust in digital transformation and everything in between—to accelerate progress towards a better society and a sustainable world.

BSI is an Equal Opportunity Employer dedicated to fostering a diverse and inclusive workplace.

Key Details

Key Skills: Intelligence, Information Technology Sales, Accounts, Auto Parts, Data Analysis
Employment Type: Full Time
Experience: Years
Vacancy: 1