I am collaborating with a world renowned medical devices manufacturer who is looking for a Senior Quality Engineer to manage quality activities from NPI projects through to post-market surveillance. This is definitely a great learning opportunity!
Reporting into the Senior Quality Manager, you will be one of the key liaison person among the R&D team, manufacturing sites across 3 different countries and various internal and external stakeholders.
What are the main responsibilities?
Actively engage in design assurance activities such as DHF support, design control guidance to internal stakeholders, development of test methods, validation protocol execution, design reviews, risk management and support design transfers
Extensively support in QMS and quality operations, ensuring compliance to various international standards across various manufacturing sites and contract manufacturers
Lead root cause analyses for non-conformance issues and ensure appropriate corrective and preventive actions were carried out to drive closure of CAPA
Partake in both internal and external quality audits and support continuous improvement projects
To be the successful individual, you will:
- Have a Degree or professional certifications in quality, engineering or related fields
- At least 7 years' of quality experience in the medical devices or biotechnology space. environment
- Strong experience in engineering drawings changes, labeling changes, specifications reviews, QMS-related activities and process validations is highly advantageous
- Proficient in using Microsoft Excel and Power Point, Auto-CAD and SolidWorks.
- Highly driven and ambitious personality with strong communication skills to liaise with both internal and external stakeholders.
- Possesses good leadership skills with strong multi-tasking abilities to drive project in meeting milestones, yet maintaining compliance composure.
This role with offer you:
- Challenging job scope and an opportunity to work with the best innovators in the industry
- Exposure to different working cultures
- Attractive salary package and benefits
Please send your resume in WORD format by clicking the apply button below or contact Kareen Wong on +65 6701 1518 for a confidential discussion. Please note that only short-listed candidates will be contacted. CEI Reg. Number R1878552 (Wong Yin Ling, Kareen).