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Director, Product Quality
Orthalign - Irvine, CA
posted about 2 months ago
About the position
The Director of Product Quality at OrthAlign, Inc. is responsible for overseeing and implementing quality control processes to ensure the delivery of high-quality medical devices. This strategic role involves establishing quality standards, leading quality assurance across various functions, and ensuring compliance with regulatory policies. The position requires collaboration with cross-functional teams and the management of supplier quality to enhance product quality visibility.
Responsibilities
- Develop and implement product quality assurance strategies to meet customer expectations and regulatory requirements.
- Establish robust quality control processes across design control, manufacturing, inspection, and supplier controls.
- Define and document quality standards and specifications for products, ensuring alignment with customer needs and industry best practices.
- Oversee supplier quality management processes, including supplier selection, qualification, and performance evaluation.
- Develop and implement systems for monitoring and evaluating product quality metrics and applicable process metrics at various states of the product lifecycle.
- Continually evaluate processes around product quality to improve efficiency and effectiveness.
Requirements
- A BA/BS degree and 10+ years of experience in quality engineering or senior management level in quality within a medical device environment, or 15 years of experience with a degree.
- Understanding of orthopedics, device software, and electromagnetic systems strongly preferred.
- Demonstrated expertise in interpreting and applying quality management systems to meet ISO 13485, 21 CFR Part 820, EU MDR 2017/745, and ISO 14971 requirements.
- Strong proficiency with Microsoft Office365 (Word, Excel, PowerPoint, Teams, SharePoint) and PDF software.
- Excellent written, verbal, and presentation communication skills.
- Strong interpersonal relationship skills to effectively interact with all levels of management and staff.
Benefits
- Competitive compensation including bonus and equity
- Opportunities for career advancement
- Full benefits package
- An evolving, engaging culture and workplace
