Job Title: Design Quality Lead
Global Healthcare Company
Location: Greater Phoenix Area
- Design Quality Management: Oversee the design quality process from concept to product release, ensuring compliance with industry standards, regulations, and internal quality guidelines.
- Cross-Functional Collaboration: Collaborate with design, engineering, and manufacturing teams to establish quality standards, specifications, and protocols. Foster a culture of quality throughout the product development lifecycle.
- Risk Management: Conduct risk assessments and implement risk mitigation strategies to anticipate and prevent potential quality issues. Utilize tools such as FMEA (Failure Modes and Effects Analysis) to identify and address design risks.
- Quality Assurance: Develop and implement quality assurance processes, protocols, and testing methodologies. Conduct product testing, analyze results, and provide recommendations for improvements.
- Regulatory Compliance: Stay updated on relevant regulations and standards (such as FDA, ISO, and other global regulatory requirements) and ensure product designs adhere to these regulations.
- Root Cause Analysis: Lead investigations into product failures or quality issues, conduct root cause analysis, and implement corrective and preventive actions (CAPA) to prevent recurrence.
- Continuous Improvement: Drive continuous improvement initiatives within the design quality function. Identify areas for process optimization, efficiency enhancements, and cost-effectiveness.
- Documentation: Maintain accurate and comprehensive documentation related to design quality activities, including test reports, compliance records, and quality metrics.
- Bachelor's or Master's degree in Engineering, Quality Management, or related field.
- Minimum 4 years of experience in design quality assurance within the healthcare or medical device industry.
- Strong understanding of quality management systems, standards, and regulatory requirements.
- Proven experience in risk management, root cause analysis, and corrective/preventive action implementation.
- Excellent analytical, problem-solving, and communication skills.
- Ability to work collaboratively in a cross-functional team environment.
- Certifications such as Six Sigma, ASQ Certified Quality Engineer, or similar, are a plus.