Director of Quality Assurance
3 weeks ago
Job Title: Director of Quality Assurance
Job Summary:
OrthAlign, Inc. is seeking a Director of Quality Assurance to oversee and implement quality control processes to ensure the delivery of high-quality products. The ideal candidate will have a strategic mindset to establish quality standards, implement product quality assurance policies, and lead a team of QA professionals.
Key Responsibilities:
- Develop and implement product quality assurance strategies to ensure products meet customer expectations and regulatory requirements.
- 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.
Requirements:
- Bachelor's degree in a related field and 10+ years of experience in quality engineering or senior manager level in quality, in a medical device environment.
- Strong understanding of orthopedics, device software, and electromagnetic systems.
- Demonstrated expertise interpreting and applying quality management systems to meet the requirements of ISO 13485, 21 CFR Part 820, EU MDR 2017/745, and ISO 14971.
- Strong proficiency with Microsoft Office365 and PDF software.
- Excellent written, verbal, and presentation communication skills.
What We Offer:
- Competitive compensation including bonus and equity.
- Opportunities for career advancement.
- Full benefits package.
- An evolving, engaging culture and workplace.
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