Quality Assurance Lead

We are seeking a highly skilled Quality Assurance Lead to oversee and implement quality culture initiatives across our organization. This role will be responsible for driving continuous improvement, ensuring compliance, and managing risk throughout the software medical device development lifecycle.

• Drive Quality Culture:
  • Foster awareness and promote a strong focus on quality to enhance customer satisfaction, particularly during product development. Implement quality culture initiatives within your team and across the organization, ensuring that defined processes are followed and continuously improved.
• Ensure Compliance:
  • Guarantee that products comply with legal and normative requirements. Tailor processes as needed to meet both business and statutory requirements, ensuring the highest standards of product quality.
• Risk Management:
  • Effectively manage and review product risk activities, including performing risk analysis, generating risk management reports, and ensuring appropriate mitigation strategies are in place.
• Collaboration with Cross-functional Teams:
  • Work closely with onsite teams and other cross-functional departments to ensure alignment with expectations, facilitating effective communication and collaboration on quality initiatives.
• Quality Management Planning:
  • Define and implement a robust quality strategy, ensuring that the quality management plan is followed throughout the complete lifecycle of the medical device, from product definition to end of support.
• Audit Experience:
  • Experience conducting audits or participating in audits, preferably in the medical device industry using MDSAP methodology.
• Communication and Organizational Skills:
  • Excellent communication and presentation skills, with the ability to effectively moderate discussions and present to all levels of the organization.
• Problem-Solving Expertise:
  • Strong critical thinking skills and the ability to resolve high-impact, complex problems across cross-functional teams.

To succeed in this role, you should have:

• A Bachelor's or Master's degree in Engineering, MCA, or a related field with an excellent academic track record.
• 4-8 years of successful experience in Quality Management within the medical device software development lifecycle, particularly in a distributed international environment.
• Familiarity with the latest trends in software product development (e.g., Trunk-Based Development, Continuous Delivery, DevOps) and their application in the medical device industry.
• Proficiency in quality tools for metrics data analysis and decision-making. Ability to interpret data and make informed decisions that drive continuous improvement.

We offer a dynamic and challenging work environment where you can grow professionally and develop your skills. You will have opportunities to collaborate with experienced professionals, gain new knowledge, and take on responsibilities that will help you achieve your career goals.

This is a unique opportunity to join our organization and contribute to our mission of delivering high-quality medical devices that improve patients' lives.

Educational Background:

• A Bachelor's or Master's degree in Engineering, MCA, or a related field with an excellent academic track record.

Quality Management Experience:

• 4-8 years of successful experience in Quality Management within the medical device software development lifecycle, particularly in a distributed international environment.

Knowledge of Software Product Development:

• Familiarity with the latest trends in software product development (e.g., Trunk-Based Development, Continuous Delivery, DevOps) and their application in the medical device industry.

Advanced Analytical Skills:

• Proficiency in quality tools for metrics data analysis and decision-making. Ability to interpret data and make informed decisions that drive continuous improvement.

Audit Experience:

• Experience conducting audits or participating in audits, preferably in the medical device industry using MDSAP methodology.

Communication and Organizational Skills:

• Excellent communication and presentation skills, with the ability to effectively moderate discussions and present to all levels of the organization.

Problem-Solving Expertise:

• Strong critical thinking skills and the ability to resolve high-impact, complex problems across cross-functional teams.

Proficiency in Tools:

• Advanced knowledge of MS Office tools (Word, Access, Excel, PowerPoint, and Outlook). Ability to use these tools for documentation, reporting, and presenting key findings.