Officer - Quality Engineering

About the role

We are seeking a talented and detail-oriented Quality Engineering Officer to join our team at Ain Medicare Sdn Bhd in Kota Bharu, Kelantan. As a full-time Quality Engineering Officer, you will play a crucial role in ensuring the highest standards of product quality and regulatory compliance within our manufacturing operations.

What you'll be doing

• Developing and implementing quality control processes and procedures to monitor and maintain product quality.
• Ensure compliance to all standards, regulations and practices related to the company such as internal Standard Operating Procedures (SOPs), Current Good Manufacturing Practice (cGMP), ISO Standards published by the International Organisation for Standardisation (ISO), Medical Device Regulations, Halal Standards for pharmaceuticals and medical devices (MS 2424 and MS2636) and other industry specific manuals and protocols as well as Occupational Safety and Health (OSH) guidelines in daily operations.
• Participate in activities related to Audits (internal and external), Risk Assessment, Change Control, Corrective Action & Preventive Action (CAPA) and investigation on Deviation/Out of Specification (OOS) according to the related SOPs; or assist superior by providing inputs for above activities.
• As backup person for Vendor Audit coordinator, to ensure vendor audit plan is adhered to the best ability, barring unavoidable circumstances.
• Performing risk assessment for vendor audit scheduling to prioritize vendor.
• Execute vendor audit according to SOP and requirement to ensure vendor’s reliability of quality and supply.
• Ensuring compliance with relevant industry regulations and standards.
• Participate in investigation of product complaint, recall or internal quality involving material. Conducting specification and process improvement activities by analysing data from vendors, complaints, Quality Assurance System Department and Production Department.
• Communicate with vendor for Vendor Non-Conformance (VNC) issued by ICQC section and ensuring vendor provide Corrective Action and Preventive Action (CAPA) within agreeable working days.

What we're looking for

• Degree in a relevant field such as Quality Engineering, Chemical Engineering, or a related discipline with quality engineering in pharmaceutical field.
• Minimum 2 years of experience in a quality engineering role, preferably in the pharmaceutical industry.
• Have basic skills in report writing.
• Strong knowledge of Quality Engineering and Vendor Management.
• Proficient in data analysis and the use of quality control software and equipment.
• Excellent attention to detail and problem-solving skills.
• Effective communication and interpersonal skills to collaborate with cross-functional teams.
• Ability to work independently and as part of a team.

What we offer

At Ain Medicare Sdn Bhd, we are committed to providing a supportive and rewarding work environment for our employees. Some of the key benefits you can expect include:
- Comprehensive health insurance coverage
- Competitive salary
- Opportunities for career development and training

About us
AIN MEDICARE SDN BHD, established in Malaysia in 1993, is a trusted name and leading manufacturer of pharmaceutical products, ranging from Large Volume Parenterals, Small Volume Parenterals, Irrigation Solutions, Haemodialysis Concentrates and Peritoneal Dialysis Solutions. A wholly-Malaysian owned company, AIN MEDICARE is helmed by our Chairman, Dato’ Wan Ariff Bin Wan Hamzah and Chief Executive Officer, Mr Redziwan Bin Saari. Over the years, this far-sighted leadership and strategic management system has successfully steered the company towards numerous remarkable achievements. Today, AIN MEDICARE’s authorised share capital stands at RM 20 million with paid up share capital of RM 20 million.

AIN MEDICARE’s products have gained international acceptance and are used by both the private and public health care sectors as well as non-profit healthcare providers in Malaysia and abroad benefiting millions of people across the globe.

Join our dynamic team and be a part of our continued growth and success.

Apply now for this exciting opportunity as a Quality Engineering Officer at Ain Medicare Sdn Bhd.