The Quality Manager is responsible for developing, implementing, and maintaining the organization’s quality system for medical/non-medical software products. This includes ensuring that the quality system complies with all applicable regulatory requirements, such as ISO 13485, 21 CFR Part 820, and IEC 62304. The Quality Manager is also responsible for conducting risk assessments, developing quality plans, performing/overseeing audits, and investigating nonconformities.

　　Your Role:

　　Develop, implement, and maintain Innovation Engineering’s quality system for medical software products in accordance with applicable regulatory requirements.

　　Lead and collaborate with a team of quality assurance professionals responsible for conducting risk assessments, developing quality plans, performing audits, and investigating nonconformities.

　　Ensure that all quality system procedures are up-to-date and followed by all employees.

　　Train employees on quality system procedures and regulatory requirements.

　　Oversee internal audits of the quality system.

　　Investigate nonconformities and implement corrective actions.

　　Prepare and maintain quality system documentation.

　　Represent the company at regulatory inspections and or notified body audits.

　　Stay up-to-date on changes to applicable regulatory requirements.

　　Identify and implement opportunities for quality improvement.

　　Prepare Management reviews and collect and trend monthly KPIs, including post-market and complaints data.

　　You're the right fit if:

　　Bachelor's degree in Quality Assurance, Engineering, or a related field

　　Overall 14 to 18 years of Industry Experience

　　Minimum of 6 years of experience in quality assurance for medical software products

　　Experience with ISO 13485, 21 CFR Part 820, and IEC 62304

　　Strong understanding of quality system principles and practices

　　Excellent command of the English language

　　Ability to use statistical software to generate trends based on the product/process data.

　　Ability to work independently and as part of a team.

　　Preferred Qualifications:

　　Master's degree in Quality Assurance, Engineering, or a related field

　　Experience in medical device software development

　　Certification in ISO 13485 or a related quality system standard

　　About Philips

　　We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.

　　Learn more about our business.

　　Discover our rich and exciting history.

　　Learn more about our purpose.

　　If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.