Director, Product Quality

1 week ago

Irvine, United States OrthAlign Inc. Full time
Job DescriptionJob DescriptionSalary: $165k+/yr DOE

OrthAlign, Inc., a Smart Technologies, growing medical device company, has an immediate opening for a Director of Product Quality.  The Director of Product Quality plays a pivotal role in overseeing and implementing quality control processes to ensure the delivery of high-quality products. This position requires a strategic mindset to establish quality standards, implement product quality assurance policies, lead design quality assurance, operations quality, and supplier quality, oversee inspection functions, enhance visibility to product quality, and lead a team of QA professionals.  Responsible for ensuring compliance with quality management system and regulatory policies/procedures in product quality, this position will liaison closely with the Quality Systems team, Research and Development, and the Operations team.

 

You will:

  • Develop and Implement Product Quality Assurance Strategies:  Formulate and execute comprehensive quality assurance strategies to ensure products meet customer expectations and regulatory requirements.  Establish robust quality control processes across design control, manufacturing, inspection, and supplier controls. 
  • Define Quality Standards:  Define and document quality standards and specifications for products, ensuring alignment with customer needs and industry best practices.  Collaborate with cross-functional teams to ensure consistency and adherence to product quality objectives.
  • Supplier Quality Management:  Oversee supplier quality management processes, including supplier selection, qualification, and performance evaluation.  Establish clear quality requirements for suppliers and collaborate with them to ensure adherence to quality standards, while also providing visibility into supplier quality performance metrics.
  • Quality Monitoring and Evaluation:  Develop and implement systems for monitoring and evaluating product quality metrics and applicable process metrics at various states of the product lifecycle.  Oversee the inspection functions to ensure compliance with quality standards, while also enhancing visibility to product quality data.  Process Improvement: Continually evaluate the processes around product quality to improve the efficiency and the effectiveness of the processes.

 

You need:

  • A BA/BS degree and 10+ years of experience, or 15 years of experience with a degree, in a professional capacity of quality engineering or senior manager level in quality, in a medical device environment
  • An understanding of orthopedics, device software, and electromagnetic systems strongly preferred
  • 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, as they apply to ensuring product quality
  • Demonstrated performance setting and leading teams to achieve goals and objectives, with ability to lead through ambiguity and changing priorities
  • 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, including negotiating and coaching


 We offer:

  • Competitive compensation including bonus and equity
  • Opportunities for career advancement
  • Full benefits package
  • An evolving, engaging culture and workplace


It is an exciting time at OrthAlign - make your next career move with us

 

Please note that we are unable to provide any type of sponsorship at this time.

No recruiters, please.

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