QRC Specialist

At Getinge we have the passion to perform

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge, our passion is to secure that every person and community have access to the best possible care, offering hospitals and life science institutions products and solutions that aim to improve clinical results and optimize workflows. Every day we collaborate to make a true difference for our customers – and to save more lives.

Are you looking for an inspiring career? You just found it.

To support the business in SEA region in all aspects of quality and regulatory compliance.

Duties and responsibilities:

• Familiar with ISO 13485, ISO 9001, and GDPMDS
• Implement and maintain QMS & GDPMDS in SIngapore, including coordinating annual inspection audit, and management review activities
• Support in QMS related activities, e.g. monthly review, audits, process reviews, and improvements, CAPA, complaints, etc.
• Manage Adverse Event reporting according to local regulation and GLobal SOP
• Coordinate and execute Field Safety Corrective Action (FSCA) per local regulation and Global SOP
• Compile and prepare product registration package and other relevant licenses applications, change notifications, renewals
• Ensure timely update of product registration details in databases in a compliant and timely manner
• Source documents and guidelines, consolidate file and maintain product technical information
• Keep close tract of changes in country regulatory requirements, and provide regulatory intelligence on the current and upcoming new regulations/ guidelines
• Perform all other duties assigned by the Company and/or Manager

Requirements:

• Diploma/ Degree in Biomedical/ Science/ Engineering or other relevant fields
• 1-2 years of relevant experience in QA/ RA, preferably in medical device industry
• Familiar with ISO 13485/ ISO 9001/ GDPMDS, and possess knowledge in Medical Device regulations
• Responsible, work independently, detail oriented
• Ablt to manage and prioritize multiple projects and tasks to meet deadlines

About us 

Getinge is on an exciting transformation journey constantly looking for new ways to innovate together with our customers to meet the healthcare challenges of the future. We are committed to diversity, equity and inclusion and to sustainability with a goal to be CO2 neutral by 2025. We believe in giving our employees the flexibility they need and make every effort to foster a learning culture that supports their personal development and creativity. Our passionate people hold our brand promise ‘Passion for Life’ close to heart. 

If you share our passion and believe that saving lives is the greatest job in the world, then we look forward to receiving your application and resume. We hope you will join us on our journey to become the world’s most respected and trusted Medtech company.

Benefits at Getinge:

At Getinge, we offer a comprehensive benefits package, which includes:

• Health, Dental, Vision and Travel insurance benefits
• Registered Pension Plan with company match
• Paid Time Off
• Wellness initiative & Health Assistance Resources
• Life Insurance
• Short and Long Term Disability Benefits
• Hybrid Work Arrangements (where applicable)
• Parental and Caregiver Leave
• Tuition Reimbursement

Getinge is an equal opportunity employer. Getinge will, at all times, will comply with all applicable human rights and other legislation when considering all qualified applicants for employment. Accommodations are available upon request for candidates taking part in all aspects of the selection process.