Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.
Main Objective:
Assists and supports the APAC Snr Quality Assurance Manager in performing quality related activities for SEA region. Maintains understanding and compliance to corporate or regional quality requirements affecting SEA operations and products, and in turn establishing process and procedures for Singapore Arthrex Subsidiary and SEA Distributor Markets. Areas of responsibility may include but are not limited to; Documentation Controls, Post Market Surveillance (Complaints & Field Actions), QMS internal audits and certification audits, Supplier and Distributor management, Management Review, change management, Non-Conformances and CAPA management as well as improvement projects for Singapore and SEA as a region.
Essential Duties and Responsibilities:
- Maintains document management system for Singapore document control ensuring Good Documentation Practice such as document and record accuracy and completeness as well as integrity.
- Establish Quality process documents, and provide assistance to departments outside of Quality department on establishing SOPs or WI or forms.
- Quality Liason with Third Party suppliers or distributors and provide support on Quality activities in Singapore and SEA operations.
- Complaints entry into Complaint Management System, perform regulatory review on AE determination for complaints, follow up on complaint device returns, and writing closeout letters to customer.
- Perform AE & FSCA reporting to HSA.
- Raise, manage and follow up effectiveness on NCs and CAPAs.
- Communicates to Management team on emerging quality system issues or risks related to customer, internal/external audit, and CAPA trends in Singapore.
- Facilitate field actions execution through communication with various departments.
- Plan, conduct or support supplier/ distributor and internal audits within Singapore and SEA region ensuring effectiveness of quality management system. Writes audit reports and follow up with audit findings with respective department.
- Provide support to Distributors on enquires for documentation, complaint updates or other quality related activities.
- Maintain Quality agreements with Suppliers and Distributors.
- Perform analysis of internal quality data and prepare management reports on quality metrics.
- Support global and regional continuous improvement projects.
Education and Experience:
- Bachelor’s Degree required, preferably in a Science or Engineering discipline.
- Preferably with at least 5 years of direct experience in administration of quality system elements within a medical device organization within the Singapore market.
Knowledge and Skill Requirements/Specialized Courses and/or Training:
- Knowledge and a clear understanding of regulations of HSA and other countries in SEA market.
- Working experience in implementation and maintainence of the ISO 13485:2016 standard
- Excellent and proven interpersonal skills
- Strong English oral and written communication skills required.
- Analytical and inquisitiveness over work processes.
- Ability to work independently in a fast paced environment and handle multiple tasks and requests.
- Comprehension of orthopedic technical/engineering/medical terminology, or can reference literature for understanding.
- Preferably 5 years experience in Quality Assurance function in the medical device industry or equivalent.
All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
