Head of Design Quality

📋 Description

• Fulfill the role of the Quality representative in Design and Development Projects.

• Responsible for creating and maintaining Risk Management files for products.

• Provide Quality Assurance assistance for assay and software verification and validation tasks.

• Review and approve Assay Verification and Validation Protocols and Reports.

• Review and approve Software Verification and Validation Protocols and Reports.

• Assess Design Changes to determine their impact on products developed under design controls.

• Conduct risk assessments for Design Changes.

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

• Collaborate with functional departments to ensure compliant task execution and resolution of protocol variances.

• Manage and document Design Control activities.

• Maintain the product Risk Management File in accordance with ISO 14971:2019.

• Assist in developing and enhancing the Quality System to meet ISO 13485 and FDA 21CFR820 and other relevant regulations.

• Support post-launch design changes and product updates as needed.

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

• Adhere to all functions and responsibilities outlined in UDx documents.

⛳️ Requirements

• Preferably hold a Bachelor’s degree in Life sciences or a related field.

• Possess over 15 years of experience in a Quality Management role in the Medical Device industry or equivalent.

• Have more than 4 years of experience in IVD working with FDA approved class III IVD products or equivalent.

• Single site PMA experience is a must.

• Proficient in interpreting 21CFR820, IVD single site PMA projects, and reviewing Assay and Software documentation.

• Familiar with implementing 21CFR820, ISO 13485, ISO 14971, ISO 62304, and CLIA Regulations 42 CFR 493.

🏝️ Benefits

• Enjoy 22 days of PTO with the option to carry over 10 days to the next year.

• Take Company Holidays and have your Birthday off!

• Access company-sponsored benefit plans, including medical, dental, and vision insurance, life, STD, and LTD coverage, and 401(k).

• Benefit from a flexible work schedule.

• Receive relocation support to the DFW area for on-site roles.

• Plus more perks to be revealed.