Quality Engineer

Quality Engineer

Are you passionate about quality, innovation, and making an impact in the medical industry? Join our team at SunTech Medical as a Quality Engineer and play a critical role in driving continuous improvement and ensuring the highest standards in quality systems and processes. Reporting to the Director of Quality Assurance, this role offers a dynamic environment where you’ll lead quality initiatives, solve complex challenges, and contribute to the success of new product development and sustaining engineering projects.

What You'll Do

As a Quality Engineer, you will:

• Lead Data-Driven Problem Solving: Analyze data, perform root cause analysis, and design experiments to address complex quality challenges, ensuring timely and effective resolutions.
• Ensure Compliance and Excellence: Drive adherence to regulatory requirements and product/process goals, aligning quality initiatives with organizational objectives.
• Support Quality Systems: Oversee CAPAs, internal and external audits, and nonconformance investigations to maintain a robust quality management system.
• Resolve Customer Complaints: Investigate design and manufacturing-related issues, implementing solutions to enhance customer satisfaction and product reliability.
• Promote Continuous Improvement: Develop and analyze trending reports, fostering corrective actions and optimizing processes across the organization.
• Collaborate on Supplier Quality: Manage supplier qualification, evaluations, and CAPA investigations to ensure consistent delivery of high-quality goods and materials.
• Champion New Product Development: Act as the Quality SME, ensuring quality plans, product acceptance criteria, and risk management processes are integral to new product launches.
• Foster a Culture of Quality: Collaborate with cross-functional teams to drive a proactive quality mindset, enabling operational success and regulatory compliance.

What You'll Bring

Education:

• Bachelor’s degree in Engineering or equivalent work experience.

Experience:

• 3–5 years of relevant experience, preferably in the medical industry.

Technical Skills and Competencies:

• Proficiency in Microsoft Office Suite and SPC tools and techniques.
• Strong technical writing skills, including experience with protocol development and validation processes (IQ/OQ/PQ).
• Expertise in regulatory standards such as FDA regulations, EU MDD/MDR, ISO 13485, 21 CFR 820, and ISO 14971.
• Proven ability to lead cross-functional teams as a quality expert.
• Exceptional problem-solving, teamwork, and detail-oriented capabilities.

Soft Skills:

• Self-motivated with a proactive approach to achieving results.
• Excellent communication and interpersonal skills to effectively collaborate across functions.
• Initiative and foresight to anticipate and address challenges.

Physical Requirements:

• Ability to lift up to 20 lbs.
• Work is performed in a normal office environment.