Senior Manager, Quality Project Engineering

Smith & Nephew; Penang; Hybrid; USD 60,000 - 90,000; Full time

Job summary

A leading company in medical technology seeks a Senior Manager, Quality Project Engineering in Penang. In this role, you will lead quality functions, ensuring compliance with regulatory standards while supporting product introductions and quality improvement initiatives through advanced methodologies. The ideal candidate has strong engineering skills, extensive managerial experience, and a commitment to quality and innovation.

Benefits

Generous annual bonus

Flexible Vacation and Time Off

Private Health and Dental plans

Paid Volunteering Hours

Hybrid Working Model

Hands-On, Team-Customised Training

Qualifications

• 5–10 years of experience in Quality Engineering roles.
• Experience in FDA and European regulatory environments.
• Hands-on experience with quality tools like SPC and DOE.

Responsibilities

• Lead quality improvement initiatives using PDCA and Kaizen.
• Oversee non-conformance management and CAPAs.
• Develop sampling plans and control plans for process integrity.

Skills

Project Management

Lean Six Sigma

Statistical Analysis

Risk Management

Education

Bachelor's degree in Engineering or related field

Tools

Statistical software

Job description

Senior Manager, Quality Project Engineering page is loaded

Senior Manager, Quality Project Engineering

Apply locations MYS - Penang time type Full time posted on Posted Yesterday job requisition id R82928

Senior Manager, Quality Project Engineering

Life Unlimited. At Smith+Nephew, we craft and manufacture technology that takes the limits off living.

The Quality Engineering Manager plans, executes, and leads the Quality function for the site, focusing especially on sustaining products or value streams. This includes product introduction or FAI, risk management, product and process validation, control plans, corrective and preventive actions, non-conformances, complaint investigations, and production support, while ensuring compliance with regulatory and company requirements.

What will you be doing?

• The Quality Engineering Manager plays a pivotal role in driving quality improvement initiatives through the application of methodologies such as PDCA, Six Sigma, Lean, and Kaizen. They conduct benchmarking and statistical analysis to identify process and product improvements, support efficient solutions, and maintain compliance with global regulatory standards (e.g., QSRs, ISO 13485, MDD). The role is also responsible for supporting internal and external audits, periodic line assessments, and ensuring that corrective and preventive actions are successfully implemented.

• Partnering closely with cross-functional teams including R&D and global suppliers, the manager ensures robust application of design controls, risk management, and process validation—particularly in support of new product introductions, design transfers, and lifecycle management. They oversee key quality processes such as non-conformance management, CAPAs, customer complaints, and Material Review Board activities. Quality metric ownership and strategic feedback on product, material, and component transfers are also core to this role.

• In addition, the manager owns the development and application of sampling plans, control plans, and measurement systems to maintain manufacturing process integrity. They evaluate process variation, validate changes for compliance risks, and support strategic site-level planning. Ultimately, this role ensures that patient safety and product quality are maintained through proactive quality engineering strategies and a strong culture of compliance and continuous improvement.
  

What will you need to be successful?

• The ideal candidate should possess a Bachelor's degree, preferably in Engineering or a related technical field, with 5–10 years of meaningful experience, including prior management or supervisory roles. A strong background in manufacturing or operations within FDA and European regulatory environments is helpful, along with in-depth knowledge of product and process risk management aligned with FDA and ISO standards. The role also favors individuals with demonstrated success in implementing effective risk mitigation strategies and hands-on experience using sophisticated quality tools such as Six Sigma, Lean, SPC, DOE, and Reliability. Familiarity with statistical software and the ability to analyze and present data for effective decision-making are also key strengths for this position.

• Additionally, the role requires strong technical acumen, including knowledge of manufacturing equipment, process validation, and New Product Introduction (NPI) processes. A detailed understanding of GMP/ISO regulations is essential, along with proven capabilities in project management, leadership, and team supervision. The position values candidates with solid troubleshooting skills, good judgment, and the ability to provide strategic direction. Strong mentoring, coaching, and people leadership proficiencies are critical to succeed in this role.
  

You. Unlimited.

We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.

• Inclusion, Diversity and Equity: Committed to Welcoming, Celebrating and Thriving on Diversity, Learn more about our Employee Inclusion Groups on our website (https://www.smith-nephew.com/)

• Your Future: Generous annual bonus and pension Schemes, Save As You Earn share options.

• Work/Life Balance: Flexible Vacation and Time Off, Paid Holidays and Paid Volunteering Hours, so we can give back to our communities!

• Your Wellbeing: Private Health and Dental plans, Healthcare Cash Plans, Income Protection, Life Assurance and much more.

• Flexibility: Hybrid Working Model (For most professional roles).

• Training: Hands-On, Team-Customised, Mentorship.

Stay connected and receive alerts for jobs like this 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 our Glassdoor page for a glimpse behind the scenes and a sneak peek into You . Unlimited . , life, culture, and benefits at S+N.

Explore our new website and learn more about our mission, our team, and the opportunities we offer.

About Us

165 years of pioneering innovation requires a relentless focus on what’s next. We’re focused on you. You’re what’s next...Ready to take your career to the next level? Join our talent community for access to new job opportunities. Sign up now!