Quality System Engineer- Medical Devices

Quality System Engineer- Medical Devices
Quality System Engineer- Medical Devices: Software Engineering / Medical Device / Pharmaceutical Industry / GCP / GXP / ISO 14155 / ISTQB / ISO / IEC 27001/ CFR Part 820/CSV, MDR, CE , 510(k)/ Clinical Investigations / Englisch
Projekt:
For our client, a major pharmaceutical company based in Basel, we are looking for a Quality System Engineer- Medical Devices
Background:
Digital Health Technologies (DHTs), including those with medical device capabilities, are critical for enhancing patient value. To address the varying measurement needs across our clinical trials, we partner with multiple third-party DHT manufacturers. While DHTs are necessary to provide critical evidence to support medical decision making, they add complexity to study delivery and require different technical skills. Addressing these complexities necessitates specialized support to assess regulatory identity, manage technical documentation, review manufacturer data, and coordinate change control activities.
We seek a dedicated quality systems engineer consultant to provide additional DHT Technical Capabilities to help us fill critical gaps for assessing regulatory identity, technical documentation, change control, remediation and upskilling activities to help train teams new to working with DHTs.
Your expertise will be instrumental in bridging our current capability gaps, ensuring compliance, and enabling the seamless integration of DHTs across Clients Pharma's assignment is based within the Digital Endpoints and Patient Solutions (DEPCS) group's Product Management and Design team, and cover needs across product development portfolio.
The Perfect Candidate:
Quality engineering expert with 7+ years of experience in the medical device or pharmaceutical industry. They possess deep expertise in digital and medical device regulatory activities (CFR Part 820/CSV, MDR, CE , 510(k)), including evidence generation and submission development. They have a proven track record of leading, conducting, and reviewing technical documentation for risk management, design controls, and change control, and conducting clinical evaluations for medical devices within clinical trials.
Additionally, the ideal candidate is someone adept at guiding third-party manufacturers through a Sponsor's processes and working through complex situations that may involve more than one QMS or policy, finding the best solution.
Responsibilities:
* Serving as the single point of contact: for technical conversations with third party device manufacturers regarding design controls, risk management, and agreements. Act as the Subject Expert (SME) on device requirements and technical nuances; also ensure these elements are appropriately integrated into study protocols and documentation.
* Compile and maintain the „Asset List" (Technical Documentation), perform technical reviews of manufacturer data, and author or review technical content for submission documents.
* Digital & Regulatory Identity: Co-lead the regulatory characterization of DHTs with the Product Management & Design Leaders, which involves providing input into Clients's internal Device Regulatory Assessment and supporting updates.
* Change Control: Act as the intake point and primary assessor for changes during a study, rigorously evaluating the impact on technical accuracy, documentation, and overall study integrity. Work will also help inform third party manufacturers of updates needed in their design control documentation.
* Evaluation: Support manufacturer qualification activities with Quality, Product Managers, Business Strategy & Operations and Procurement teams to evaluate vendor capabilities and identify technical gaps to inform viability of use as a third party manufacturer.
* Review Manufacturer Design History Files (DHFs) and product development documentation: from the third party DHT product manufacturers
* Conduct Risk Management and computer systems validation (CSV) for products not classified as medical device, when necessary and per Clients's global standard operating procedures (SOPs)
* Ensure compliance with Clients's internal quality standards and global standard operating procedures (SOPs) for medical devices, including sourcing, clinical investigation, risk management, and clinical performance procedures.
* Draft or support product managers, clinical scientists, or other clinical teams with drafting technical documentation or risk management plans to meet Clients SOP, ISO standards or Health Authority Requirements.
* Support upskilling: activities and plans to train team members new to medical device development, design control, regulatory assessment and quality documentation activities.
Must haves:
* BA/BS degree in Computer Science, Software Engineering, Informatics, Biomedical, related technical field or equivalent practical experience. Masters or advanced degree in Engineering, Quality Management, or related field.
* 7+ years' experience in the medical device or pharmaceutical industry
* In-depth knowledge and experience executing ISO 13485, ISO 14971, IEC 62304,IEC 82304, IEC 60601-1, 21 CFR 820, 21 CFR Part 11, Annex 11, and GAMP 5, with a strong emphasis on medical device regulations and quality management systems
* Experience conducting ISO 14155 compliant clinical investigations for medical devices, ensuring regulatory and ethical standards are met
* Experience executing ISO / IEC 27001 and cybersecurity aspects related to development of medical device products
* Software Validation & Testing: Expertise in Computerized System Validation (CSV) and software quality assurance, with an ISTQB Test Manager certification
* Experience with GCP / GxP practices and GMP
* Experience in working with the Center for Devices and Radiological Health (FDA), EU Health Authorities/MDR, and Notified Bodies
* Track record of effectively working in a matrix environment with global team members
* Fluent in English, German is of advantage
Nice to Haves:
* Cybersecurity experience - relevant ISO for products
* Past experience leading training for ISO 14971, ISO 62304/SDLC
* Past experience working with the Clients Group
Referenz Nr.: 925102
Rolle: Quality System Engineer- Medical Devices
Industrie: Pharma
Arbeitsort: Basel
Pensum: 100%
Start: () (Latest Start date )
Dauer: 12+ Months
Bewerbungsfrist:
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