Global Operations is a complex and diverse organization within the company which is responsible for product fulfilment to all our customers from end to end. We pride ourselves on being totally Customer Centric in our unrelenting focus on Improving Quality, Service and Value as perceived by our customers. Our employees are dedicated to the Global Operations Enterprise Excellence journey. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.
Position Summary
Principal Responsibilities
1. To be responsible & accountable for the review, update, implementation & compliance to the Design Control Procedures at TFX Malaysia.
2. Routinely provides design control guidance to R&D engineers for the duration of a project assignment.
3. Assist in completion of risk management and risk analysis/assessment activities with R&D Project Leader/ Dev. Engineer, QA Technical team & RA for the Technical File submissions in compliance to the latest updated MDD requirements.
4. To liaise with R&D Project Leader/Dev. Engineer & RA on Essential Requirements analysis including standards review and evidence of conformity.
5. Support of regulatory submission. Manage the compilation of design verification and shelf life data for regulatory submissions to support product approval and release. Interface with Regulatory Affairs to ensure information is clearly presented to minimize Regulatory Agency questions.
6. Support various QA/RA activities including quality management, system reviews, standard review, audits, etc.
7. To lead, coordinate and support R&D related NCs, CAPAs, Risk Assessments/Evaluations and Deviations.
8. To strategize and lead all R&D project related validation activities and product related ISO gap assessments.
9. Participate in Internal and External quality audits as directed by the R&D Manager.
10. Support Post Market Surveillance activities for the Design File upon 6-12 month launch of the new development product on the market, which includes reviews, complaints review (if any), customer / marketing feedback of the device with reference to PM-03-01.
11. To ensure the implementation and effective management for Occupational Safety and Health consistence with the Occupational Safety & Health Act 1994 and other legislative requirements
12. And any other assignment / task as deemed fit.
Education / Experience Requirements
Qualification :
Degree in Polymer Science, Material Science, Chemical Engineering or related field.
Experience
a) Minimum 5 years working experience in a Medical Product line with in-depth knowledge of Design Control Procedure & Regulatory plus ISO/QSR (GMP) Regulations related to Medical Device Manufacturing.
b) Ability to interpret, adapt & provide guidance on product regulation.
c) Good communication skills enabling independent and interactive working across the Organization.
d) Methodical thinker able to interpret regulatory requirements into meaningful business requirements
e) Work independently according to establish methods and SOP’s to perform analytical testing as required.
f) Ability to Influence scientific thinking and direction of projects
