Senior Quality Engineer

A leading manufacturing and production industry in Penang is seeking a Senior Quality Engineer to join their dedicated team, where your commitment to patient safety and product quality will be at the heart of everything you do.

This role offers an exceptional opportunity for you to make a meaningful impact by ensuring the highest standards of quality are maintained throughout the manufacturing process. You will be empowered with independent authority to make critical decisions related to product quality, and your expertise will be instrumental in driving continuous improvement initiatives across the department. The organisation values flexibility, professional growth, and a supportive environment that encourages collaboration and knowledge sharing. If you are passionate about quality engineering and thrive in a setting where your skills are recognised and nurtured, this is the perfect opportunity for you.

• You will have direct influence on patient safety and product quality through daily execution of sound quality practices and maintenance of an effective quality system, ensuring compliance with all relevant regulations.
• The role provides significant autonomy in decision-making regarding product quality, including disposition of non-conforming products, root cause analysis, and corrective actions, allowing you to shape outcomes that matter.
• You will benefit from a collaborative workplace culture that promotes continuous improvement, professional development, and knowledge sharing among team members, fostering both personal and organisational growth.

What you'll do:

As a Senior Quality Engineer based in Penang, you will play a pivotal role in upholding rigorous standards of patient safety and product quality. Your day-to-day responsibilities will involve interpreting technical documents, making key decisions regarding non-conforming materials, investigating manufacturing defects, and collaborating with cross-functional teams to resolve issues efficiently. You will lead efforts in customer complaint investigations using specialised software tools while also training others on these systems. Your expertise will be called upon during CAPA investigations as well as validation activities for new or modified products. By championing continuous improvement initiatives from vendor selection through to customer satisfaction, you will help drive best practices across the department. Your ability to review operational data critically ensures that technical specifications meet industry standards. Success in this role requires not only technical proficiency but also strong interpersonal skills as you guide junior engineers and inspection staff while working collaboratively with suppliers, other engineering disciplines, EHS teams, and customers.

• Select appropriate techniques for problem solving and consistently provide Engineering and Quality Assurance recommendations that support patient safety and product quality.
• Read and interpret technical drawings, procedures, and protocols to ensure accurate understanding and implementation of quality requirements.
• Exercise independent authority to make decisions related to product quality, including the disposition of non-conforming products within the manufacturing process.
• Identify manufacturing process defects such as scrap, nonconforming material, or customer complaints by dispositioning non-conforming material, assisting in root cause identification, and supporting corrective and preventative actions.
• Work closely with process owners to bound product stops and document release criteria when necessary to maintain high standards of operational excellence.
• Participate actively in customer complaint investigations for areas under your control, documenting findings in detailed analysis reports using GCS2 software.
• Become a trainer for software related to complaints handling processes (GCS2), providing guidance and support as required to colleagues across the department.
• Support the execution and investigation of CAPAs (Corrective Action Preventive Actions), NCEP (Nonconformance Event Process), Failure Mode Investigations, ensuring thorough documentation and follow-up.
• Review and approve operational, test, and validation data to establish technical specifications and performance standards for newly designed or modified products and processes.
• Champion continuous improvement initiatives from a quality perspective within the department, influencing vendor selection/approval through to customer awareness/satisfaction.

What you bring:

To excel as a Senior Quality Engineer in Penang, you will bring proven experience gained over at least nine years within operations quality roles—ideally within the medical device sector. Your academic background in engineering or related sciences provides a solid base for navigating complex regulatory landscapes such as ISO13485. You possess advanced analytical abilities that allow you to dissect problems methodically using root cause analysis techniques supported by statistical tools like Excel or Minitab. Your hands-on experience with risk assessments ensures swift identification of issues while your clear communication style fosters understanding among diverse stakeholders. Familiarity with validation lifecycles means you can confidently oversee planning through reporting phases for new or modified products. Additionally, your exposure to product transfer processes enhances your versatility within operations quality management. As someone who understands internal auditing procedures intimately, you contribute proactively towards maintaining compliance across all facets of the business.

• Bachelor’s degree in engineering, technology or related science is essential for this position as it forms the foundation for understanding complex quality systems.
• Minimum of nine years’ working experience in Operations Quality demonstrates your depth of knowledge in maintaining high standards within manufacturing environments.
• Prior experience in the medical device industry is highly desirable as it equips you with familiarity around regulatory requirements specific to healthcare products.
• Comprehensive understanding of ISO13485 requirements and QMSR or equivalent regulations ensures compliance with international standards governing quality management systems.
• Experience running or owning nonconforming event risk assessments and investigations allows you to effectively identify root causes and implement corrective actions.
• Ability to interpret, execute, and support the full validation lifecycle from planning through reporting is crucial for establishing robust technical specifications.
• Strong analytical skills including problem solving methodologies such as RCA (Root Cause Analysis) combined with statistical analysis using tools like Excel or Minitab enable data-driven decision making.
• Clear communication skills are vital for conveying investigation findings effectively across multiple stakeholders including process owners, suppliers, customers, and internal teams.
• Experience in product transfer processes is considered an added advantage as it broadens your scope within operations quality management.
• Familiarity with internal auditing processes supports ongoing compliance efforts within the organisation.

What sets this company apart:

This organisation stands out by placing genuine emphasis on patient safety and product quality at every level of its operations. Employees are encouraged to take ownership of their work while benefiting from a supportive leadership structure that values collaboration over hierarchy. The company fosters an inclusive environment where knowledge sharing is promoted through regular training opportunities—including becoming trainers on specialised software systems—and where professional development is prioritised alongside operational excellence. Continuous improvement is not just a buzzword here; it is embedded into departmental objectives from vendor selection right through to customer satisfaction. The organisation’s commitment extends beyond compliance with regulatory standards—it actively seeks ways to enhance environmental responsibility by partnering with EHS teams on impactful projects. For those looking for flexible working opportunities coupled with generous training support within a knowledgeable network of professionals who value dependability and empathy above all else, this is an ideal place to grow your career.

What's next:

If you are ready to make a lasting impact on patient safety and product quality while advancing your career in a collaborative environment, this Senior Quality Engineer role could be your next step—apply now!

Apply today by clicking on the link provided or email me at jackelyn.wong@robertwalters.com to discuss this new opportunity!

Do note that we will only be in touch if your application is shortlisted.

Agensi Pekerjaan Robert Walters Sdn Bhd
Business Registration Number : 729828-T
Licence Number : JTKSM 423C