Quality Engineer job opportunity at Smith+Nephew.

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DatePosted 10 Days Ago bot
Smith+Nephew Quality Engineer
Experience: 4-years
Pattern: full-time
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loacation MYS - Penang, Malaysia
loacation MYS - Penang....Malaysia

Quality Engineer   Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.   The Quality Engineer leads and delivers engineering projects that require advanced technical expertise, applying broad and in-depth knowledge of engineering principles across complex assignments. The role may include coordinating technical support staff and contributing to the technical development of team members. The role applies Quality Engineering tools and risk-based problem-solving to support the development, transfer, and sustainment of products and processes across the full product lifecycle. Responsibilities include improving process capability, preventing failure modes, supporting base business operations, reviewing and approving DHR for shipment, and analyzing non-conformances and customer complaints through root cause investigations.   What will you be doing? Business Improvements Support quality improvement initiatives to drive continuous and cost improvements. Analyze effectiveness of PDCA, Six Sigma, Kaizen, Lean, and other improvement programs. Conduct benchmarking to identify better quality methods. Support quality engineering and compliance for new product introductions and product lifecycle management.   Compliance/Regulatory Review products and processes for compliance with global regulations (FDA, ISO, MDD, TGA, ANVISA, MHLW, China GMP). Champion adherence to standards and support internal/external audits. Conduct periodic line audits and ensure corrective/preventive actions are effective.   New Product/Process Introduction Partner with R&D and cross-functional teams to apply design controls and risk management. Support design transfer and introduction of new products.   Product Quality, Control & Disposition Lead and maintain Material Review Board activities. Investigate and approve non-conformances, CAPAs, and customer complaints. Ensure material identification, segregation, defect classification, and quality metrics maintenance. Review and approve Device History Records (DHR).   Product/Process Qualification Approve IQ, OQ, PQ, TMV, and software validation. Develop and implement process control plans, measurement systems, and sampling plans. Partner with operations, engineering, and suppliers to manage process validation, control, and risk. Collect and analyze data to support process improvements and day-to-day manufacturing. Assess process variation and measurement effectiveness for risk mitigation.   Risk Mitigation Document and analyze changes to ensure no increase in risk or non-compliance. Evaluate effectiveness of risk mitigation techniques on processes and products.   Strategic Develop and maintain effective quality strategies for process, design, and test method validation.   Other Duties Comply with HSE, sustainability, and energy policies. Prevent injuries, environmental issues, and energy waste. Report incidents and provide feedback for continuous improvement. Undertake special projects assigned by the Line Manager based on experience. What will you need to be successful? The Quality Engineer position is based in Batu Kawan, Penang, Malaysia, and requires a Bachelor’s degree in Engineering or a related technical field with at least 4 years of relevant experience. The role is ideal for candidates with experience in FDA and European regulatory environments, manufacturing operations, and a strong track record in risk mitigation, process validation, and New Product Introduction (NPI). Proficiency in Statistics, Lean, and Six Sigma methodologies (including MSA, SPC, DOE, and reliability analysis), as well as the ability to analyze, interpret, and present data to drive decision-making, is essential. Candidates should also have a solid technical understanding of manufacturing equipment and processes, along with hands-on troubleshooting and problem-solving skills. The role requires excellent English communication skills, advanced mathematical and analytical abilities, and strong reasoning to define problems and implement solutions. The Quality Engineer will spend a mix of time standing, walking, and using computers, performing measurements, and visually inspecting products, with up to 10% travel. This position also demands adherence to GMP/ISO standards, regulatory compliance, and effective project management, making it suitable for a highly competent, detail-oriented professional capable of leading quality initiatives and supporting process improvements across the product lifecycle. You.Unlimited. We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.     Inclusion + Belonging - Committed to Welcoming, Celebrating and Thriving. Learn more about our Employee Inclusion Groups on our website https://www.smith-nephew.com/   Work/Life Balance: Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day   Your Wellbeing : Medical, Dental, Vision, Health Savings Account , Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program   Flexibility : Hybrid Work Model (For most professional roles)   Training: Hands-On, Team-Customized, Mentorship Stay connected by joining our Talent Community . We're more than just a company - we're a community! Follow us on LinkedIn to see how we support and empower our employees and patients every day.    Check us out on Glassdoor for a glimpse behind the scenes and a sneak peek into You. Unlimited. , life, culture, and benefits at S+N. Explore our website and learn more about our mission, our team, and the opportunities we offer.  

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