MARDZLINA BTE SIDEK
HEAD OF DEPARTMENT , QUALITY ASSUARANCE
Bandar Baru Bangi,10
Summary
Experienced Department Head with strong Manufacturing Medical Device background. Promote growth and team performance with skilled leadership of day-to-day operations and special projects. Forward-thinking and highly responsive to emerging trends affecting department operations and goals.
16 Years' Experience in Quality Assurance with strong knowledge in ISO 13585 Medical Devices QMS and ISO 14971 for Risk Management. Involved as Internal Auditor for 14 years and competence well in managing department with achievement in utilizing Manpower project.
Overview
17
17
years of professional experience
2
2
Languages
Work History
Department Head, Quality Assurance
Medijoy International Sdn Bhd
Sendayan, Negeri Sembilan
01.2019 - Current
- Managed efficient workflows by creating effective schedules and delegating work based on personnel strengths and knowledge.
- Enforced organizational rules and incorporated policy changes into departments' day-to-day activities.
- Ensured compliance with industry regulations by implementing and enforcing policies and procedures within the department.
- Stages reviewed and amend existing document for effectiveness practice in In-Process Control and Quality meanwhile established new document for additional control to excel the Quality performance in parallel to Customer Requirement and Company Goal and vision.
- Facilitate proactive Solution by collecting and analyzing Quality data and presented Monthly Quality Meeting to Stakeholders affirmatively for Improvement
- Launched quality assurance practices for each phase of development with two ways communication implementation between stakeholder and production.
- Implemented strong control and evaluation procedures to maximize departments' work quality.
- Evaluated performance continuously to identify areas in need of improvement and implement strategies to keep team on-track.
- Improved staffing during busy periods by creating employee schedules and monitoring call-outs.
- Cultivated collaborative, performance-oriented culture to keep team motivated and enthusiastic about achieving shared goals.
- Proactive Communication for any level of stakeholders in achieving same goal target towards Zero defect programmed by enhancing CAPA in daily production routine.
- Authorize and responsible for Product Release for shipment by providing COC for product guarantee
- Responsible for Supplier evaluation and assessment
- Involved as team for Supplier Audit
- Involved as team for Internal Auditor
- Enhanced customer satisfaction through proactive problem-solving measures and excellent communication strategies with clients.
- Maintained positive customer relations by addressing problems head-on and implementing successful corrective actions.
Sr. Supervisor
Meditop Corporation (M) Sdn Bhd
Bandar Baru Bangi, Selangor
01.2017 - 01.2019
- In charge Product Qualification for New project for material and product diversity
- In charge Sterile Barrier System study to fulfilled ISO 11607-1
- Established new procedure for testing
- Assist Department Head for any discussion with Stakeholders related to product development or product transfer evaluation test
Sr. Supervisor
Meditop Corporation (M) Sdn Bhd
Bandar Baru Bangi , Selangor
01.2013 - 01.2016
- Coordinated, supervised and evaluated work of subordinates and reallocated staff and resources to meet performance requirements.
- Supervise and train Inspector new procedures
- Established a guideline for Incoming inspection such Operating Instruction, Inspection and Test Plan
- Assessed problems and conflicts and resolved independently.
- Handling Customer complaint related to purchased Materials
- Handling complaint issuance to Supplier and effectively follow up for corrective action
Supervisor
Meditop Corporation (M) Sdn Bhd
01.2008 - 01.2012
- Perform Cleanroom Monitoring such particle count, bacteria count and finger test by monthly basis
- Perform physical test and established Do's and Don'ts for Operators
- Perform Physical, dimension and Function test for part acceptance activities
- Monitor preventive maintenance for lab equipment
- Perform product release system activities
- Monitor staff attendance and behaviors
Education
BACHELOR (HONOR) - Minor Engineering
PETROLEUM CHEMISTY
Universiti Putra Malaysia 07.2005 - 04.2008
Some College (No Degree) - Life Science
Kolej Matrikulasi Melaka
Melaka 05.2024 - 05.2005
Skills
- ISO 13485 Compliance
- Regulatory Compliance Expertise
- Internal Audit Specialist
- Supplier Evaluation Audit
- Risk Evaluation
- Effective Communication
- Detail-Oriented Approach
- Statistical Evaluation
- Personnel Management
- Hazard Evaluation Skills
- Understanding Human Behavior in Engineering
- HAZOP Risk Assessment
- Medical Device Distribution Compliance
- Medical Device Risk Management
Personal Information
Age: 38 years 5 months
Watching movie
My hobbies is watching movies and serial drama especially from Japan and Korea. This is because I appreciate the nature approached of every film recorded with indirect moral of story. Besides , watching drama and movies helps me to reduce and naturalize my feeling after exhausted days. I normally watch the drama and movies depending on my feeling that days in order to help me soothing my mix inner feeling. As for me it is very good therapy and definitely to keep this therapy as part in managing workplace stress.
Timeline
Some College (No Degree) - Life Science
Kolej Matrikulasi Melaka
05.2024 - 05.2005
Department Head, Quality Assurance
Medijoy International Sdn Bhd
01.2019 - Current
Sr. Supervisor
Meditop Corporation (M) Sdn Bhd
01.2017 - 01.2019
Sr. Supervisor
Meditop Corporation (M) Sdn Bhd
01.2013 - 01.2016
Supervisor
Meditop Corporation (M) Sdn Bhd
01.2008 - 01.2012
BACHELOR (HONOR) - Minor Engineering
PETROLEUM CHEMISTY
07.2005 - 04.2008
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