QUALITY ENGINEERING ENGINEER (Medical Device)

Pentamaster Corporation Berhad; Penang; On-site; MYR 72,000 - 144,000; Full time

Job summary

Pentamaster Corporation Berhad in Penang is seeking a Quality Engineering Engineer (Medical Device) to join our Healthcare & Medical division on a full-time basis. You will ensure medical device products meet quality, safety and regulatory standards, collaborating across design, manufacturing and regulatory affairs.

You will develop and maintain QA protocols, perform audits, CAPA, risk assessments (FMEA), and support FDA, CE marking and GMP compliance.

Qualifications

• Bachelor's degree in Engineering or equivalent qualification.
• 3–5 years in quality engineering/QA, preferably in medical devices or pharma.
• Strong knowledge of ISO 13485, FDA, GMP and CE marking.
• Experience with SPC, DOE and CAPA methodologies.
• Experience with quality management software and ERP systems is advantageous.
• ASQ CQE or Six Sigma certification is desirable.

Responsibilities

• Develop, implement and maintain QA protocols for medical device manufacturing.
• Conduct audits, inspections and testing across production stages.
• Identify deviations and implement CAPA actions.
• Collaborate with design, manufacturing and regulatory teams.
• Prepare and maintain SOPs, work instructions and quality records.
• Support FDA, CE and other regulatory activities.
• Perform FMEA risk assessments to mitigate quality risks.
• Provide training on quality standards to staff.
• Maintain calibration and validation records for equipment.
• Drive continuous improvement in product quality and efficiency.

Skills

Quality engineering

CAPA

SPC

DOE

Root cause analysis

Education

Bachelor's degree in Engineering

Tools

ERP

Document management systems

Job description

QUALITY ENGINEERING ENGINEER (Medical Device)

About the role

Pentamaster Corporation Berhad is seeking a skilled and dedicated Quality Engineering Engineer (Medical Device) to join our team on a full-time basis in Penang. This is a strategic position within our Healthcare & Medical division, specifically focused on Pharmaceuticals & Medical Devices. As a Quality Engineering Engineer, you will play a crucial role in ensuring that our medical device products meet the highest standards of quality, safety, and regulatory compliance. Your work will directly impact patient safety and the company's reputation in the healthcare industry. This role offers the opportunity to work at the intersection of engineering excellence and healthcare innovation.

Key responsibilities

Develop, implement and maintain quality assurance protocols and procedures for medical device manufacturing and assembly processes

Conduct comprehensive quality audits, inspections and testing of medical devices throughout all stages of production

Identify, document and analyse quality issues, deviations and non-conformances, implementing corrective and preventive actions (CAPA)

Collaborate with cross-functional teams including design, manufacturing and regulatory affairs to ensure quality standards are met

Prepare and maintain quality documentation, including Standard Operating Procedures (SOPs), work instructions and quality records

Support regulatory compliance activities, including FDA, CE Mark and other international medical device regulations

Perform risk assessments and failure mode and effects analysis (FMEA) to identify and mitigate potential quality risks

Conduct training programmes for manufacturing staff on quality standards and best practices

Manage and maintain calibration and validation records for testing equipment and manufacturing systems

Drive continuous improvement initiatives to enhance product quality and manufacturing efficiency

What we're looking for

Bachelor's degree in Engineering (Mechanical, Electrical, Manufacturing or related discipline) or equivalent professional qualification

Minimum 3-5 years of professional experience in quality engineering or quality assurance, preferably within the medical device or pharmaceutical manufacturing industry

Strong knowledge of medical device regulations and standards, including ISO 13485, FDA requirements, Good Manufacturing Practice (GMP) and CE marking requirements

Proficiency in quality management systems and tools such as Statistical Process Control (SPC), Design of Experiments (DOE) and root cause analysis methodologies

Experience with quality management software and systems, including ERP and document management systems

Excellent analytical and problem-solving skills with meticulous attention to detail

Strong communication and interpersonal skills with the ability to collaborate effectively with diverse teams

Certification in quality management (such as ASQ Certified Quality Engineer or Six Sigma) is highly desirable

Familiarity with medical device product design, manufacturing processes and assembly techniques

Ability to work independently and manage multiple projects simultaneously whilst meeting deadlines

What we offer

Pentamaster Corporation Berhad is committed to fostering a supportive and inclusive workplace environment where employees can thrive professionally and personally. We offer competitive remuneration packages commensurate with experience and qualifications. Our benefits include comprehensive health and medical coverage, professional development opportunities and training programmes to enhance your career progression. We recognise the importance of work-life balance and provide flexible working arrangements where applicable. As part of our commitment to employee wellbeing, we encourage participation in company wellness initiatives and provide a collaborative, innovative work culture that values your contributions. We also support continuous learning and career advancement through mentorship programmes and opportunities to engage with the latest industry practices and technologies.

About us

Pentamaster Corporation Berhad is a leading global provider of precision manufacturing and automation solutions, with a strong presence in the Healthcare & Medical sector, particularly in Pharmaceuticals & Medical Devices. With headquarters in Penang, Malaysia, we are committed to delivering innovative, high-quality solutions that contribute to advancing healthcare globally. Our company is built on values of excellence, integrity and customer-centricity. We pride ourselves on our engineering expertise, cutting-edge technology capabilities and dedicated team of professionals who are passionate about making a positive impact in the medical device industry. We maintain rigorous quality standards and compliance with international regulations to ensure that our products consistently exceed customer expectations and contribute meaningfully to patient safety and healthcare outcomes.

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.

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.