Beschreibung
This position will provide support operational Quality Assurance activities at key design, development and manufacturing vendors (in the GMP & ISO environment) for development and commercial vendors and specific internal QA support/consultancy for all Medical Devices such as drug delivery devices but more specifically medical mobile apps (Software as medical Devices), sensors and potentially IVDs. This will be achieved through close partnering with QA management at vendors sites and collaboration with the companies Technical Operations and other internal teams.
Accountabilities:
Design & Development management:
Provide expert advice, support and management for technical operational QA and general QA matters for specific vendors, on behalf of the company, in design/development of medical devices (including medical mobile apps) and combination products ensuring application of ISO and GMP requirements.
Specifically focused on the following:
- Oversee Design & Development activities
- Review and approve protocols and reports for Verification & Validation studies, technology transfers, stability studies, etc
- Provide expert support to internal partners to assure systems are in place to manage novel new drug introducer technologies
- Facilitate investigations and resolution of issues relating to deviation and change management
- Review and approve deviations during D&D activities
- Lead/review critical investigations
- Track CAPA events and closure
- Oversee/track Design change controls
- Ensure application of ISO, MDR and GMP requirements where applicable
- Review and approve documentation
- Review and approve submissions and responses
- Review and approve relevant sections of the device Technical Documentation File as required
- Release Clinical Trial Medical Devices
- Ensure Design History File (DHF) is in place
- Accommodate design & technology transfer and ensure systems alignment between vendor and company
- Performing focused assessments/audits
- Prepare Quality Agreement
General QMS:
- Maintain Quality System elements associated with the ISO and GMP activities in a compliant manner
- Drive/Support projects related to quality system improvement
- Maintain key performance indicators (metrics) for key operational development QA activities and services associated with the Medical Devices activities
- Maintain GMP compliance and inspection/audit readiness at all times. Support Commercial QA in the inspection/audit preparation activities, during inspection/audit and for closure of inspection/audit observation with associated CAPA commitments
- Support Medical Devices related inspections
- Support Management Review Process
- Support Design Reviews
Experience Requirements:
- Minimum of 5 years working in the pharmaceutical/biologics/medical device industry in a quality management position. Operational GMP experience or clinical activities experience would be a distinct advantage.
- Practical understanding of ISO13485:2016, MDR, ISO14971 and 21CFR820 and part 4 requirements.
- Practical experience in development or QA management of Software as Medical Devices, Vital signs Sensors or IVDs
- Practical experience in ISO13485, ISO14971, MDD/MDR and 21CFRpart 820 with main focus on Design Control
- Either experience with 21CFR part 4 OR Medical Mobile Apps regulation
Allegis Group Limited operates as an Employment Business and Employment Agency as set out in the Conduct of Employment Agencies and Employment Businesses Regulations 2003. It is a company within the Allegis Group network of companies (collectively referred to as "Allegis Group"). Aerotek, Aston Carter, EASi, TEKsystems, Stamford Consultants and The Stamford Group are Allegis Group brands. If you apply, your personal data will be processed as described in the Allegis Group Online Privacy Notice.
To access our Online Privacy Notice, which explains what information we may collect, use, share, and store about you, and describes your rights and choices about this, please go to website.
We are part of a global network of companies and as a result, the personal data you provide will be shared within Allegis Group and transferred and processed outside the UK, Switzerland and European Economic Area subject to the protections described in the Allegis Group Online Privacy Notice. We store personal data in the UK, EEA, Switzerland and the USA. If you would like to exercise your privacy rights, please visit the "Contacting Us" section of our Online Privacy Notice on our website for details on how to contact us. To protect your privacy and security, we may take steps to verify your identity, such as a password and user ID if there is an account associated with your request, or identifying information such as your address or date of birth, before proceeding with your request. If you are resident in the UK, EEA or Switzerland, we will process any access request you make in accordance with our commitments under the UK Data Protection Act, EU-U.S. Privacy Shield or the Swiss-U.S. Privacy Shield.