Quality System Engineer- Medical Devices

Quality System Engineer - Medical Devices

For our client, a major pharmaceutical company based in Basel, we are looking for a Quality System Engineer
- Medical Devices in the digital health technologies arena. 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. A limited number of internal experts possess the technical skills required to manage regulatory identity assessments, documentation needs, and change control, leading to bottlenecks that delay study starts and risk the successful integration of DHTs.

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 Mark, 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.

The ideal candidate is also 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.

• Serve 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 Matter Expert (SME) on device requirements and technical nuances; 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.
• Assist in Digital & Regulatory Identity:
  Co‑lead the regulatory characterization of DHTs with the Product Management & Design leaders, providing input into the company’s internal Device Regulatory Assessment and supporting updates.
• Act as the primary intake point and assessor for change control during a study, rigorously evaluating the impact on technical accuracy, documentation, and study integrity. Inform third‑party manufacturers of necessary updates to their design control documentation.
• Support manufacturer qualification activities with Quality, Product Managers, Business Strategy & Operations and Procurement teams to evaluate vendor capabilities and identify technical gaps for viability assessment.
• Oversee manufacturer delivery and lead remediation efforts (when needed) to address updates to documentation.
• Review Manufacturer Design History Files (DHFs) and product development documentation from third‑party DHT product manufacturers.
• Conduct Risk Management and Computerized System Validation (CSV) for products not classified as medical devices, as required by the company’s global SOPs.
• Ensure compliance with internal quality standards and global 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 SOPs, 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.

• BA/BS degree in Computer Science, Software Engineering, Informatics, Biomedical, or related technical field, or equivalent practical…