QARA Engineer

Science is a clinical stage, vertically integrated technology company focused on solving some of neuroscience’s hardest questions and most serious unmet medical needs. We work to restore quality of life to those with debilitating conditions for which there are no treatment options, creating devices aimed at restoring vision, cognition, and mobility to patients who have lost it. To support progress across our industry, we provide state-of-the-art components and vertically integrated infrastructure for others to build on via Science Foundry.

The QARA Engineer will support efforts to ensure the regulatory and quality compliance of our implantable product throughout its lifecycle, from clinical trials to future commercialization. The QARA Engineer will assist in quality inspections, good clinical practices, and maintaining other facets of the Quality Management System (QMS); additionally, there will be opportunities to participate in preparing for regulatory submissions. The ideal candidate thrives in a dynamic environment and can seamlessly shift between production quality and clinical/regulatory support activities.

Role responsibilities:

• Identify opportunities to optimize quality processes and reduce regulatory burden while maintaining compliance. Lead continuous improvement initiatives to reduce cycle times and eliminate redundancies.
• Implement automated solutions for routine quality tasks and regulatory reporting.
• Assist in maintaining and enhancing the QMS to ensure efficient compliance with ISO 13485, MDR 2017/745, FDA: 21 CFR Part 820 and other applicable regulations.
• Conduct product release inspections, managing quality control processes, and collaborating with production teams.
• Support production line quality issues, batch release, and product development as required.
• Perform inspection and testing of purchased materials, components and products in accordance with policy and procedures.
• Manage equipment calibration, qualification, and preventive maintenance schedules. Troubleshoot equipment issues and coordinate repairs with vendors.
• Work cross-functionally to identify, root cause, and resolve quality issues (e.g. nonconforming product); implement corrective and preventative actions.
• Coordinate with clinical teams on quality aspects of trial protocols and documentation.
• Review and prepare quality system documents, including SOPs, work instructions, and quality records, ensuring alignment with internal and regulatory standards.
• Prepare quality reports and metrics for management review.
• Aid in quality system training; ensure employees are trained to perform their work and that their training is documented.
• Participate in internal and supplier audits, design reviews, and risk assessments to support the development and manufacturing processes.
• Prepare and maintain Risk Management Files.
• Review device labeling and advertising materials for compliance with regulatory product approvals and applicable country regulations; analyze and recommend appropriate changes.
• Assist in developing and implementing streamlined global regulatory strategies for new and modified medical devices.
• Support regulatory submission filings (technical file for CE marking, UKCA documentation, PMA, etc.), medical device reporting and recalls.
• Manage external documents and regulatory watch.

Key qualifications:

• Engineering Degree or equivalent in quality, regulatory and/or life sciences.
• A minimum of 3 years of experience in the medical device industry in quality assurance and/or regulatory affairs department.
• Excellent communication skills (written and verbal) in English
• Professional proficiency in French.
• Proven ability to adapt between hands-on technical work and documentation/regulatory tasks
• Ability to understand complex processes and their documentation needs.
• Ability to understand standards and regulations and interpret them into clear requirements as they relate to the company.
• Detail-oriented with strong organizational and problem-solving skills.
• Ability to work with cross-functional teams and a committed team player.

Preferred qualifications: 

• Experience with implantable medical devices or Class III medical devices.
• Strong knowledge of global medical device regulations, particularly MDR 2017/745, 21 CFR Part 820, Good Manufacturing Practices, ISO 9001, ISO 13485, ISO 14971, ISO 62366, Good Clinical Practices, and ISO 14155.
• Understanding of materiovigilance requirements.

Science Corporation is an equal opportunity employer. We strive to create a supportive and inclusive workplace where contributions are valued and celebrated, and our employees thrive by being themselves and are inspired to do their best work. 

We seek applicants of all backgrounds and identities, across race, color, ethnicity, national origin or ancestry, citizenship, religion, sex, sexual orientation, gender identity or expression, veteran status, marital status, pregnancy or parental status, or disability. Applicants will not be discriminated against based on these or other protected categories or social identities. Science will also consider for employment qualified applicants with criminal histories in a manner consistent with applicable federal, state and local laws.