QC INSPECTOR (For medical device)

Pentamaster Corporation Berhad

Penang

Vor Ort

MYR 39.000 - 58.000

Vollzeit

vor 37 Stunden

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Zusammenfassung

Pentamaster Corporation Berhad is seeking a dedicated QC Inspector (medical device) in Penang. The role entails conducting rigorous visual and functional inspections, dimensional checks, and meticulous documentation to ensure compliance with FDA, ISO 13485 and internal standards.

You will collaborate with production and engineering to implement corrective actions and drive continuous improvement. The ideal candidate has a high school diploma and hands-on QC experience in pharma/medical devices,

Qualifikationen

High school diploma or equivalent; quality control training/engineering background preferred.
Proven experience as a QC Inspector in medical device/pharma manufacturing.
Strong knowledge of medical device regulations (FDA, ISO 13485) and quality mgmt standards.
Proficiency with precision measuring instruments (calipers, micrometers, gauges, CMM).
Skilled in statistical quality control and interpreting quality data.
Excellent attention to detail and accuracy.
Good communication and teamwork skills.
Familiarity with QC software and computerised inspection systems.
Able to work under pressure and adapt to shift work.

Aufgaben

Perform visual and functional inspections of medical devices at various production stages.
Conduct dimensional and tolerance checks using precision instruments.
Document inspection results and maintain traceable QC records.
Identify defects/non-conformities and report to relevant departments.
Collaborate with production and engineering to address quality issues.
Perform statistical analysis and monitor quality metrics.
Ensure adherence to FDA, ISO and other medical device standards.
Support internal audits and QA initiatives.
Maintain clean and organized inspection areas and equipment.
Attend training on new inspection procedures and equipment.

Kenntnisse

Visual inspection

Dimensional measurement

Statistical quality control

Documentation

Regulatory knowledge

Quality software

Attention to detail

Communication

Teamwork

Shift flexibility

Ausbildung

High school diploma

QC training preferred

Tools

Calipers

Micrometers

Gauges

Coordinate Measuring Machine (CMM)

Jobbeschreibung

About the role

We are seeking a dedicated and detail-oriented QC Inspector (For medical device) to join Pentamaster Corporation Berhad in Penang. This is a full-time position that plays a critical role in ensuring the quality and safety of medical devices throughout the manufacturing process. As a QC Inspector, you will be responsible for conducting rigorous inspections and tests to verify that all products meet stringent regulatory standards and company specifications. This role is essential to maintaining our reputation for excellence in the pharmaceuticals and medical devices sector and directly contributes to the safety and efficacy of products that reach patients worldwide.

Key responsibilities

Perform comprehensive visual and functional inspections of medical devices at various stages of production to ensure compliance with quality standards and specifications
Conduct dimensional and tolerance checks using precision measuring instruments and calibrated equipment
Document inspection results accurately and maintain detailed quality control records for traceability and regulatory compliance
Identify defects, non-conformities and deviations, and report findings to relevant departments promptly
Collaborate with production and engineering teams to address quality issues and implement corrective actions
Perform statistical analysis and maintain quality metrics to monitor production trends and process performance
Ensure adherence to regulatory requirements, including FDA, ISO and other applicable medical device standards
Participate in internal audits and support quality assurance initiatives
Maintain cleanliness and organisation of inspection workstations and equipment
Attend training sessions to stay updated on new inspection procedures, equipment and regulatory changes

What we're looking for

High school diploma or equivalent; a qualification in quality control, engineering or a related field is preferred
Proven experience as a QC Inspector or quality control technician in a medical device or pharmaceutical manufacturing environment
Strong knowledge of medical device regulations, including FDA guidelines, ISO 13485 and other applicable quality management standards
Proficiency in using precision measuring instruments such as callipers, micrometres, gauges and coordinate measuring machines (CMM)
Competency in statistical quality control methods and the ability to interpret quality data
Excellent attention to detail with the ability to identify even minor defects and deviations
Strong communication skills and the ability to work effectively within a team environment
Familiarity with quality control software and computerised inspection systems
Ability to work under pressure whilst maintaining accuracy and thoroughness
Flexibility to adapt to shift work schedules if required

What we offer

Pentamaster Corporation Berhad is committed to providing a supportive and rewarding work environment for all employees. We offer competitive compensation packages commensurate with experience and qualifications.
Our benefits include health and medical coverage to support your wellbeing and that of your family.
We provide opportunities for professional development and continuous learning through training programmes and certification courses.
We foster a collaborative workplace culture that values innovation, teamwork and personal growth.
We are committed to maintaining a safe working environment and adhering to all occupational health and safety standards.
Additionally, we offer career progression opportunities for high-performing individuals who demonstrate commitment and excellence in their roles.

About us

Pentamaster Corporation Berhad is a leading innovator in the pharmaceuticals and medical devices sector, dedicated to delivering high-quality products that improve patient outcomes. With state-of-the-art manufacturing facilities and a commitment to excellence, we design, develop and produce advanced medical devices that meet the highest regulatory standards. Our company is built on a foundation of integrity, innovation and customer focus. We pride ourselves on our skilled workforce and our ability to adapt to evolving market demands whilst maintaining the highest standards of quality and safety. Based in Penang, we serve global markets and are recognised for our technical expertise and dedication to continuous improvement.

History

Check our website http://www.pentamaster.com.my under 'Milestones'

Product & Services

Standard Semiconductor Back-end Equipment. Customized Automated Solutions. Vision Inspection System. Material Handling Solutions. Test and Measurement System. High Precision Components Manufacturing. Equipment Contract Manufacturing. Shopfloor Management System. RFID Application Solutions. Logistics and Warehouse Solutions.

Vision

To provide world class automation solutions to the Manufacturing Industries in the Global Market

Mission

We are dedicated in delivering high quality and cost effective products with value-added services. In our effort to meet our mission, we strive to provide benefits and satisfaction to our customers, vendors, employees and the community as a whole.

PENTAMASTER CORPORATION BERHAD, a Malaysian investment holding company listed on the Main Board of Bursa Malaysia Securities Berhad, is one of the global leaders in providing advanced, world-class manufacturing automation solutions & services to help worldwide customers meet their productivity challenges & maintain the edge required for success in a competitive business environment.

Through our subsidiaries, we provide an integrated range of innovative services in technological solutions, manufacturing of automated & semi-automated machinery & equipments, designing & manufacturing of precision machinery components, as well as design, assembly & installation of computerized automation systems & equipments.

With more than 25 years of experience in dealing with high-end technology companies across worldwide markets, we are confident to compete in terms of manufacturing flexibility, quality services, cost-effective solutions, timely delivery & positioned for greater growth.