Paige is a software company helping pathologists and clinicians make faster, more informed diagnostic and treatment decisions by mining decades of data from the world’s experts in cancer care. We are leading a digital transformation in pathology by leveraging advanced Artificial Intelligence (AI) technology to create value for the oncology clinical team.

We are the first company to develop clinical grade AI tools for the pathologist, which resulted in our receiving FDA breakthrough designation for our first product. Paige has also received FDA-clearance for our digital viewer, FullFocus™. We have also established multiple relationships with biopharma, laboratory, and equipment manufacturers that enables Paige to develop an ecosystem ready to help patients receive better diagnoses and treatment.

We’re seeking a Senior Quality & Compliance Engineer who will own Paige’s quality management system to continuously improve to bring it to state-of-the-art level. While improving the QMS, this individual will also assist with the regulatory submissions.

This is an extraordinary opportunity to be part of a high-performing team and to pursue a life-changing mission with unique technical challenges!

This position is available through the US as a remote role, or you may opt to work from our stunning NYC office once we the pandemic is over.  

Responsibilities

• Work with product and the engineering teams and fine tune the QMS to eliminate low value but time-consuming tasks while prioritizing quality impacting ones
• Become the in-house subject matter expert for Atlassian QMS tools
• Own the training management system and increase its effectiveness day by day
• Ease the record generation process while increasing traceability
• Draft new processes by collaborating with stakeholders and make them readable and user friendly instead of regulatory-heavy. Teams should be eager to follow these processes, not because they need to
• Understand the pain points and always try to think outside of the box
• Directly contribute to improving our software release cycles while not trading off from product quality and traceability
• Understand the pain points and always try to think outside of the box
• Work independently and propose creative solutions to highly complex quality/regulatory challenges
• While doing all this, assist in regulatory submissions/certification efforts to continue to cover other regulatory regions and enable our marketing/sales teams

 Requirements

• Extensive experience Atlassian tools; Jira and Confluence
• Extensive experience with 21 CFR Part 820 regulations
• Experience in obtaining and maintaining ISO 13485 & MDSAP certifications
• Experience in IEC 62304 software lifecycle framework
• Experience with digital health and cutting-edge AI/ML SaMD products
• Experience with internal/external auditing and should hold internal auditor certification/qualifications
• Experience with upcoming MDR regulations
• Bachelor’s degree in biomedical engineering or a related field, or equivalent years of experience.
• 4+ years' of industry experience as a quality engineer