Quality Assurance

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 maintaining the Quality Management System (QMS), preparing regulatory submissions, and ensuring adherence to relevant medical device regulations.

**Role responsibilities**:

- Assist in maintaining and enhancing the QMS to ensure compliance with ISO 13485, MDR 2017/745, FDA: 21 CFR Part 820 and other applicable regulations.
- Review and prepare quality system documents, including SOPs, work instructions, and quality records, ensuring alignment with internal and regulatory standards.
- Participate in internal audits, design reviews, and risk assessments to support the development and manufacturing processes.Regulatory
- Propose and drive continuous improvement initiatives for the Quality Management System (QMS).
- Prepare regulatory submissions (technical file for CE marking, UKCA documentation, PMA, etc.)
- Prepare and maintain the 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 regulatory strategies for new and modified medical devices.
- Support regulatory submission filings, medical device reporting and recalls.
- Manage external documents and regulatory watch.
- Work cross-functionally to identify and resolve quality issues.
- Develop and deliver quality system training.
- Ensure employees are trained to perform their work and that their training is documented.
- Interact with other departments (R&D, clinical, manufacturing) to generate protocols and reports required for registration purposes.
- Provide support to quality control and product development as required.
- Act as deputy for the materiovigilance representative.
- Act as deputy for the person responsible for regulatory compliance according to Regulation 2017/745.

**Key qualifications**:

- Engineering Degree or equivalent in quality, regulatory and/or life sciences.
- Strong knowledge of medical device regulations, particularly MDR 2017/745, ISO 13485, ISO 14971 and ISO 62366.
- A minimum of 3 years of experience in the medical device industry in QA and/or RA department.
- Excellent communication skills (written and verbal) in English and at least one other European language, preferably French.
- 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.

**Preferred qualifications**:

- Experience with implantable medical devices or Class III medical devices.
- Trained in internal and supplier audits.
- Knowledge of other medical device regulation areas.

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 law.