The Opportunity:

You will be reporting to the Sr. Director of Quality as the Head of Design Quality. The head of design quality will lead a group of Senior and Junior Quality Engineers and will ensure that products are developed according to regulatory requirements.

You will be part of a team that is passionate about developing novel diagnostic tests for the early detection of cancers. As part of the team, you will be in a Company that aims more than to become one of the leaders in the industry. We want to have a huge positive impact on society by achieving the ambitious purpose of “making cancer a curable disease by detecting it earlier”.

How you’ll contribute:

· Perform the role of the Quality representative in Design and Development Projects.

· Responsible for Risk Management file creation and maintenance for products.

· Provide Quality Assurance support to assay and software verification and validation activities.

· Perform the review and approval of Assay Verification and Validation Protocols and Reports.

· Performs the review and approval of Software Verification and Validation Protocols and Reports.

· Performs review of Design Changes to identify the impact to products developed under design controls.

· Performs risk assessments for Design Changes.

· Ensure project plans adequately address design, verification, validation and compliance requirements and standards.

· Work with functional departments to ensure tasks are executed compliantly. Ensure resolution of protocol variances are performed ensuring compliance and issues are addressed and resolved.

· Management and documentation of Design Control activities

· Management and maintenance of the product Risk Management File according to ISO 14971:2019

· Support Quality System development and improvement to comply to ISO 13485 and FDA 21CFR820 and other applicable regulations.

· Support post launch design changes and product updates as required.

· Provides Quality Assurance expertise, guidance, coaching for New Product Development and single site PMA PAI Inspections.

· Follow all functions and responsibilities associated to this position that are described in UDx documents.

What you’ll bring:

Required Experience:

· Bachelor’s degree in Life sciences, OR a related field is preferred.

· 15+ years of experience in a Quality Management role in the Medical Device, OR an equivalent combination of education, training, and/or experience.

· More than 4 years of IVD experience working with FDA approved class III IVD products, OR an equivalent combination of education, training, and/or experience.

Recommended Experience:

· Single site PMA experience required.

· Expert in the interpretation of 21CFR820, IVD single site PMA projects including the review of Assay and Software documentation.

· Working knowledge interpreting and implementing 21CFR820, ISO 13485, ISO 14971, ISO 62304 and CLIA Regulations 42 CFR 493.