Job Description

THE ROLE

A medical devices company headquartered in the US is seeking to grow their team with a Senior QA Executive who is self-motivated, takes pride in cultivating a quality culture and with great communication skills to handle responsibilities in the commercial quality activities in the ASEAN region.

OVERVIEW OF KEY RESPONSIBILITIES

• The position holder will be responsible for follow-up and maintenance of the Quality System processes, in compliance with respective Asia countries\' Quality System Regulations and/or ISO 13485.
• The incumbent will act as Management Representative for HCP reporting to the management for ensuring business activities are conducted in compliance with the regulations and applicable standards.
• Responsible of management review and Qualified Person for Singapore
• Ensures the correct implementation and maintenance of Quality Systems throughout the Company\'s representative offices and affiliates, with continuous improvement in compliance with the local regulations
• Management of internal and external audits, customer complaints, recall and withdrawals (throughout Asia), materiovigilance, deviations and CAPA
• Coordinate field safety notification and other post-market surveillance with the countries
• Manage the QA activities of distributors in Asia and ensure that their quality standards meet the Company\'s Group\'s standards
• Manages the quality aspects in the development, sourcing, and supply of non-group products for Asia markets: Audits of the supplier and/or sub-contractor; Audit of the manufacturing facility, if necessary; Follow-up of the corrective action plans; Implementation and maintenance of the quality agreements and technical specifications.
• Support global and local initiatives and projects

REQUIREMENTS

• Bachelor\'s Degree in Science or Engineering or proven relevant experience.

EXPERIENCE

• About 5 years\' of regional QA experience
• Strong interpersonal communication skills
• Ability to work cross-functionally and independently
• Excellent attention to detail and ability to deal with complexity
• Capable of effective time management
• Strong knowledge and proficiency of quality standards and regulatory requirements (e.g. ISO 13485, GMP, GDP, MDR, MDD 93/42 EEC)

If you are seeking to further your professional development in quality assurance with this valuable regional opportunity, kindly apply with your most current CV (in word format), and I will get in touch with you shortly for a confidential discussion.

Principal Consultant: Cheong Yee Yin | Registration Number: R22108633 | EA License Number: 17C8502

Additional Information

Career Level

Senior Executive

Qualification

Not Specified

Years of Experience

5 years

Job Type

Full-Time

Job Specializations

,

Company Overview

Meet Integrity. We\'re a leading recruitment firm specializing in the areas of Life Sciences and Engineering with over 100 years of combined experience in the industry. We\'ve helped recruit the most prized talent in a wide variety of Life Science and Construction sectors.

With 40% of our waking time dedicated to work, we know the vital importance of how smallest actions can create the biggest impact in people\'s lives. This is exactly why our friendly team of skilled experts always prioritizes actions based on core values over personal gain.

The secret to our business is personal relationships. Because People Matter.

We\'ve been very fortunate to assist with the recruitment of some of the most talented and dynamic talent for many of the largest and smallest employers. These are businesses who were in need of elite recruits who possessed specific talents, unique skills and other technical disciplines. Reach out to us to to discover even more about how we can help you with all of your recruiting needs or your own career.

Additional Company Information

Registration No.

201634573Z

EA No.

17C8502

Company Size

1 - 50 Employees

Industry

Human Resources Management / Consulting

Benefits & Others

Miscellaneous allowance, Long hours, Formal (e.g. Shirts + Ties)

Integrity Partners