Job Description

Position Title: QA Senior Engineer - Quality & regulatory affairs

Requirements:

Bachelor's degree in any Engineering or related field Minimum

5 years

of experience in Quality Management System (

QMS

), preferably in medical device or regulated industry. Strong knowledge of

ISO 13485

,

FDA

& other applicable regulations of medical device. Involved in

QMS setup

or production startup projects is an added advantage. Good understanding of risk management and 4M change control. Experience in handling customer audits, quality complaints, and CAPA processes. Strong problem-solving, root cause analysis, and data analysis skills. Excellent communication and interpersonal skills to collaborate with cross-functional teams & customers. Proactive, detail-oriented, and able to lead continuous improvement initiatives.

Scope of duties:

1.

Customer window

Window person to customer for any communication & enquiry, including reporting, related to quality & products Record all customer complaints and evaluate them to determine the need for investigation etc. Collect customer feedback and report to related sections for any improvement activities Compile customer quality trends (customer complaints, return products etc) Arrange with related parties for customer visits, audit etc, as the main coordinator. Lead follow-ups of audit findings until closure and report to the external party as well as to related parties.
2.

QMS

Collaborate with related parties in maintaining the QMS including the continuous improvement to ensure its effectiveness and compliance with the related standards & requirements. Establish required procedures and records with related team members following ISO 13485, FDA as well as customer requirements. Review any new regulatory or standard updates for implementation in JLLM. Conduct necessary data analysis on the QMS activities and identify areas for improvement. Provide feedback or reports to related parties as well as the management when required.
3.

NC & CAPA

Issue NCR and evaluate non-conformances. Determine the need for investigation for each of the NCR recorded. Main PIC for CAPA (issuance, reporting & follow-up) related to customer complaints and internal issues (depending on the risk to customer) Lead investigations with FRT team members and follow up on root cause investigations, corrective actions implementation, effectiveness of corrective actions etc until closure. Lead FRT & NC product disposal meetings. Lead discussions with team related to preventive actions, Yokoten, Lessons Learned etc Report to customer on CAPA updates until closure Coordinate any quality improvement plan when necessary
4.

Risk Management

Schedule & lead periodic review of risk management with related sections Provide inputs related to customer or market complaints Report any major changes, submit for approval
5.

4M Change Request

Communicate with customers on 4M change proposals Submit 4M change request to customer with proper planning, documents etc Coordinate with the internal team on the trial, testing and implementation of 4M changes, including information on breakpoints, as required Discuss with the internal team on any risks or problems related to changes Collect customer feedback related to changes implemented, if available Coordinate any improvement plan when necessary
6.

Return product

Coordinate with customer & internal team on return product (return & re-deliver etc) Lead investigation related to return products when deemed necessary Coordinate any quality improvement plan when necessary Report to customer when necessary

Benefits include:

Regular working hour from 8 am to 5 pm Monday - Friday (option to apply for flexi hour) Attractive salary offered based on experience & skills Reimbursement on mileage, toll & business trip Free & wide parking area Meal, attendance & phone allowances Corporate insurance GHS & GPA Medical benefits which include GP, dental & optical Other miscellaneous allowance
Job Type: Full-time

Pay: RM4,500.00 - RM6,500.00 per month

Benefits:

Additional leave Cell phone reimbursement Flexible schedule Free parking Health insurance Maternity leave Meal allowance Opportunities for promotion Professional development
Ability to commute/relocate:

Simpang Ampat: Reliably commute or planning to relocate before starting work (Required)
Application Question(s):

How much notice are you required to give your current employer? What's your expected monthly basic salary?
Experience:

Quality assurance: 6 years (Required) Medical devices manufacturing: 5 years (Required) medical quality & regulatory: 5 years (Required) Auditing: 5 years (Required)
Work Location: In person