Office: Central London, UK (flexible location for this role)
How to Apply: Email your CV and Cover Letter: firstname.lastname@example.org (Subject: Software Quality Assurance Manager: MDR, ISO) or visit https://www.ia-grp.com/about-us/ for more information.
IAG, Image Analysis Group, is a fast-growing imaging expert organization that supports pharmaceutical companies developing new treatments to improve patients’ lives. IAG is a unique company that works with the worlds’ top biotech and pharmaceutical innovators in clinical research, who seek objective and reliable answers on the efficacy and safety of novel drugs through imaging biomarkers. IAG brings together a solid technical expertise and advanced scientific thinking to take the best of academic innovation into clinical trial settings. Our operations are supported by IAG’s propriety cloud based platform DYNAMIKA, which brings together management of imaging data, advanced analysis of images and AI. Every project we run involves medical imaging and helps drug developers to succeed in their efforts. This role is for someone with passion for technology, deep knowledge of quality and inspiration to see how their work impacts the lives and wellbeing of others!
Why is this role potentially just right for you?
We are looking for a confident and energetic Software QA Manager, familiar with ISO13485 certified QMS, CE and FDA510K class II medical device regulations. In this role you will need to bring together engineering and clinical research standards, and find the most optimal way to bridge the systems and optimize procedures.
One Week in This Role:
You will support technical and operational teams in achieving their quality objectives and working with Chief Operating Officer and Chief Technology Officer, reporting to CTO. You will be involved in the software development activities, and in particular in the required technical documentation for regulatory purposes. You will also work on unifying quality processes required by technical and operational teams. You will be responsible for staff training, record keeping, QMS updates and success of the quality audit meetings, both internal and external. There is a close work with quality auditors on the client side as well as the management of the clinical research projects.
QMS and Standards
- Support design, implementation, monitoring and improvement of the QMS.
- Assist in establishing, maintaining, overseeing and enforcing all quality assurance standards and programs to assure compliance in accordance with ISO 13485, 21 CFR 820, 21 CFR part 11, IEC 62304.
- Initiate, revise and review controlled GMP documentation including procedures and reports.
- Participate in nonconformance and CAPA identification, investigation, and resolution.
- Guide the company with the latest knowledge on current regulations and industry best practices.
- Interact with management, peers and partners to assess and improve the adequacy of the QMS processes and procedures.
- Support Employee Quality Training – design and delivery for companywide compliance. Promote a culture of quality.
- Support product management and engineering team on software development activities.
- Management of daily work (e.g.: NC / AC / AP, traceability, maintenance / updating of technical documentation, various and any);
- Periodically review and report to the Top Management the status of QMS;
- Manage the company’s processes and quality documents related to our software platform.
- Coordination and analysis of QMS metrics.
- Maintain quality assurance and design control documentation with relevant stakeholders.
- Preparation and drafting of the relevant SGQ Technical Documentations necessary in order to obtain CE marking and EU MDR Certificate of new Medical Devices;Main Legislation.
- Codify, Review and Verify Quality and Regulatory Technical Documentation to be in compliance with New Eu-MDR.
- Participate in internal and external audits for IAG and conduct third party audits of suppliers.
- Management of external vendors, including contracts, accreditation, and qualification.
- Lead regulatory inspection preparations and execution of inspections.
- Lead client audits.
- Plan and conducting internal audits.
- Maintain relations between the Company and the certifying bodies.
- Bachelor’s degree and 5+ years of experience in quality SLCD, preferably in an agile environment.
- Excellent verbal and written communication skills with the ability to work with cross-departmental functions including regulatory affairs, software developers, department leads, and end users.
- Excellent data collection and analysis skills.
- Experience with software as a medical device (FDA &ISO).
- Extra-EU Class IIa MD registration: United Kingdom.
- Experience applying risk assessment principles according to ISO14971:2019 requirements.
- Ability to thrive in a fast-paced, technical, and mission-focused environment.
- Knowledge of ISO 13485:2016; •CEI UNI EN ISO 14971:2013, CEI-EN-60601-1 and collateral rules applicable to their area of competence; UNI EN ISO 19011:2012; MDD 93/42/CEE – Dir. 2007/47/CE; New Eu MD Regulation 2017/745, MEDDEV 2.12/1 Rev.8, MEDDEV 2.7/1 Rev.4, ISO 14155-2;
How much could someone earn in this role?
Our company has a multi-part compensation structure:
- Competitive base salary based on experience and skills.
- We contribute to each employee’s pension.
- Every person is eligible to receive a competitive bonus based on exceptional individual and firm performance.