Medical Devices QA Lead - SaMD, sensors
Posted on Sep 18, 2019 by Stamford Consultants AG
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.
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
- 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
- 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
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