Design Control Process Engineer

Department: Research & Development

Location: EMEA-Israel

Description

About this opportunity

Join our R&D team as a Process Improvement & Design Quality Process Engineer in a leading medical device company. You will be responsible for driving exceptional product quality, championing regulatory affairs, and implementing/leading process improvements.

In this role, you will…

• Actively participate in product development cycle by reviewing and improving Project documentation (Hardware and Software). e.g. design plan, requirement documents, specs, testing documents etc.
• Participating in product risk assessments and design reviews, work closely with R&D to Review/approval, risk management, requirements management and trace matrix.
• Create and revise Standard Operating Procedures (SOPs) and other documentation to support the Quality System regarding software and system design.
• Work to determine and develop solutions that are imaginative, thorough, practicable, and consistent with organizational objectives.
• Lead internal audits as required by Company audit schedule.
• Follow all Quality System Practices as defined by company's practices, policies and Standard Operating Procedures (SOPs) to ensure that FDA, ISO, EU and other global quality standards and regulations are met where applicable.
• Lead Process Improvements: Evaluate existing processes and documentation, collaborating with various teams to enhance quality and efficiency.
• Collaborate with SSG Teams: Ensure superior design quality and implement efficiency improvement initiatives.
• Regulations Champion: Serve as the primary contact for regulatory matters within R&D, providing training and advice to various teams on regulatory compliance.
  
  

In this role, you’ll need …

• Above 5 years of experience in the field.
• Fundamental knowledge of ISO requirements
• Knowledge in Design control process for medical devise , advantage for the dental industry.
• Good ability to comprehend multi-disciplinary systems and processes.
• Skilled in product risk assessment, requirements management and tracing, defect tracking, configuration management and how they are applied in the product development lifecycle.
• Effective problem solving, root-cause analytical skills to lead and influence others to drive change.
• Strong written and verbal communication skillsin English & Hebrew.
• Technical writer Skills
  
  

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Global Diversity Statement

At Align, we believe in the power of a smile, and we know that every smile is as unique as our employees. As we grow, we are committed to building a workforce rich in diverse cultural backgrounds and life experiences, fostering a culture of open-mindedness and compassion. We live our company values by promoting healthy people and healthy communities, all with the intent of changing millions of lives, one unique smile at a time.

Equal Opportunity Statement

Align Technology is an equal opportunity employer. We are committed to providing equal employment opportunities in all our practices, without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, disability, sexual orientation, gender identity or expression, or any other legally protected category. Applicants must be legally authorized to work in the country for which they are applying, and employment eligibility will be verified as a condition of hire.