Senior Engineer, Innovation (Quality & Risk Management) |(ID: 685309)| (SUNJ)

PERSOL; Singapore; On-site; SGD 80,000 - 100,000; Full time

Job summary

A leading firm in healthcare consulting in Singapore seeks a professional to coordinate projects and implement quality management systems for medical device innovations. The ideal candidate holds a Bachelor's/Master's in Engineering or Science, has over 2 years of experience in QMS, and possesses strong communication and problem-solving skills. This role offers a chance to contribute to significant healthcare innovations.

Qualifications

• Minimum 2 years’ experience in QMS, risk management processes, and/or design and development of medical devices.
• Experience in ISO13485 / IEC62304 audit is preferable.
• Strong verbal and written communication skills.

Responsibilities

• Implement risk management best practices in innovation projects.
• Maintain ISO 13485 and IEC 62304-compliant quality management system.
• Support medical technology projects with regulatory guidance.

Skills

QMS knowledge

Risk management

Technical writing

Project coordination

Communication skills

Problem-solving

Education

Bachelor's/Master's Degree in Engineering or Science

Tools

ISO 13485

IEC 62304

ISO 14971

Job description

This role combines project coordination, quality management system implementation, risk assessment and technical writing. Our client is looking for candidate with experience or strong interest in supporting medical device innovations in the healthcare industry.

Job scope

• Assist to establish processes and work in a team to implement risk management best practices in innovation projects aimed at adoption and commercialisation.
• Implement and maintain the office's ISO 13485 and IEC 62304-compliant quality management system processes and procedures across departmental work and projects
• Providing guidance and development support to ongoing medical technology projects. This encompasses validating unmet clinical needs, advising project teams on regulatory, quality and risk requirements, performing risk assessments of proposed solutions with consideration of regulatory requirements, and conducting clinical need filtering and de-risking.
• Ensure compliance with quality, regulatory and organisational policies and systems while supporting required record-keeping and documentation.
• Managing project tasks includes recommending grants, ensuring timely completion of project milestones for successful grant applications, and meeting KPIs set by the grant agency and manager.

Job Requirements

• Bachelor’s/Master’s Degree in Engineering or Science with min 2 years’ experience in QMS, risk management processes, and/or design and development of medical devices
• Experience in risk management processes for medical technology development
• Experience in implementation/maintenance of a quality management system
• Experience in ISO13485 / IEC62304 audit is preferable.
• Experience in the software development lifecycle is highly advantageous
• Experience in project coordination, technical project management, and/or technical documentation implementation/maintenance is desirable
• Familiarity with ISO 13485, ISO 14971, IEC 62304, ISO14155, Medical Device Regulatory, Medical Device Standards, Risk Management for Medical Devices
• Strong verbal and written communication skills with proven teamwork abilities
• Strong problem-solving skills and technical writing skills
• Meticulous, detail-oriented, responsible and self-motivated

Interested candidates who wish to apply for the advertised position, please click on “Apply”. We regret that only shortlisted candidates will be notified.

EA License No.: 01C4394 (PERSOLKELLY SINGAPORE Pte Ltd)

By sending us your personal data and curriculum vitae (CV), you are deemed to consent to PERSOLKELLY Singapore Pte Ltd and its affiliates to collect, use and disclose your personal data for the purposes set out in the Privacy Policy available at https://www.persolsingapore.com/policies. You acknowledge that you have read, understood, and agree with the Privacy Policy.