Quality Assurance Specialist (1 Year Contract)

Baxter International; Petaling Jaya; On-site; MYR 50,000 - 70,000; Full time

Job summary

A global healthcare company located in Petaling Jaya, Malaysia, is seeking a quality assurance professional with at least 3 years of experience in medical devices or pharmaceuticals. Responsibilities include managing product complaints, ensuring regulatory compliance, and supporting quality operations. The ideal candidate should possess strong communication skills and a good understanding of quality systems.

Qualifications

• At least 3 years of relevant experience in medical devices, pharmaceutical, and biologics.
• Quality experience within a healthcare environment.
• Familiarity with Quality system and understanding of GDPMD.

Responsibilities

• Responsible for complaint-related processes ensuring compliance.
• Conduct document management and control for regulatory compliance.
• Perform quality operational tasks and maintain product return dispositions.

Skills

Quality assurance

Interpersonal and communication skills

Technical system skills

Ability to multitask and prioritize

Good sense of urgency and strong follow-up

Job description

Overview

This is whereyour work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride.

Key Responsibilities :

Key Responsibilities

• Product Complaint Related Matter / Non-Conformance / Product Recalls/FAs/Hold:
  • Responsible for complaint-related processes and ensure procedure compliance.
  • Responsible for the completion of Product Complaint reporting to ensure notification to Complaint Coordinator within required timeframe and investigation of returned samples to determine root cause.
  • Report, follow-up and trend product complaints
  • Support completion of customer acknowledgement for Field Action (FA), closure document and filing
  • Reply to customer complaints, queries related to quality, prepare any recall or FAS documentation.
  • Responsible for performing Hold activities within required timeframe.

• Quality Operation
  • Responsible for redressing instruction and filing of dispositions.
  • Responsible for release of Finished Goods with temperature controlled and after routine redressing.
  • Responsible for Product Return dispositions
  • Support distribution operations.

• Document Management
  • Document control and maintenance of records (record retention) and ensure compliance with regulatory requirements, Good Documentation Practices (GDP) and Standard Operating Procedures (SOPs)
  • Assist / Prepares SOP, Document Change Request (DCRs) and Periodic Review.

• Internal Requirements and Improvements
  • Ensure compliance with SOPs, quality assurance, internal and local regulations and GDPMDS / GDPMD Standards
  • Assist with data gathering and analysis for Quality Review / Complaint to ensure occurs at required frequency.

• Support in external and internal audits
• Regulatory reporting determination.
  • Review of complaints for overseas reporting requirements regionally.
  • Support country QA in obtaining required documentation to carry out reporting.

• Perform other duties as assigned.

Requirements

• At least 3 years of relevant experience in medical devices, pharmaceutical and biologics
• Quality experience (within a healthcare environment)
• Regional experience will be an advantage
• Familiarity with Quality system
• Good understanding of GDPMD
• Able to work independently with little supervision
• Good sense of urgency and strong follow-up
• Ability to multitask and prioritize
• Interpersonal and communication skills
• Technical system skills (e.g. word processing, spreadsheets, databases, online research)
• Ability to identify compliance risks and escalate when necessary

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please contact us with your request and your contact information.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.