Quality Assurance Specialist
3 days ago
Job Title: Quality Assurance Specialist
Company: Russell Tobin
Job Type: Full-time
Location: Cambridge (Hybrid with 2-3 days onsite per week)
Job Description:
Lead Quality Assurance and Regulatory Compliance Activities
As a Quality Assurance Specialist at Russell Tobin, you will be responsible for leading quality assurance and regulatory compliance activities for combination product development programs.
Key Responsibilities:
- Design Control and Risk Management: Lead design control and risk management activities to ensure deliverables are appropriately authored, approved, and maintained to support clinical trials and commercial licensures.
- External Design Companies and Manufacturing Facilities: Support and facilitate effective risk management activities at external design companies and manufacturing facilities related to assigned projects.
- Quality and Regulatory Standards: Ensure combination product development activities are compliant with quality and regulatory standards, both internal and external.
- Design Validation: Provide input and support to design validation, including human factors engineering assessments.
- Supplier Assessment: Support the assessment of external design companies and suppliers for capability of quality systems, facilities, and procedures to support device development and supply.
- Device Design and Manufacturing Investigations: Support device design and manufacturing investigations from devices used in clinical trials and commercial manufacture.
- Regulatory Submission Data: Support the generation of all regulatory submission data and content for assigned device projects.
- Internal and External Audits: Support internal and external audits of the DCoE Quality Management System.
Requirements:
- Education and Experience: BSc in an appropriate science and engineering discipline with a minimum of 2 years of relevant experience in the pharmaceutical combination product and/or device industries, or MSc in an appropriate science and engineering discipline with a minimum of 2 years of relevant experience in the pharmaceutical combination product and/or device industries, or PhD in an appropriate science and engineering discipline.
- History of Working with Regulatory Requirements: History of working in accordance with the requirements of ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation.
- Design Controls and Risk Management: Experience in design controls and risk management for combination products.
- Human Factors Engineering: Familiarity with Human Factors Engineering - Usability Engineering.
- Device Manufacturing Processes: Familiarity with device assembling manufacturing processes.
Technical Skills:
- Regulatory Knowledge: Working knowledge of ISO 9001, ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation.
- Industry Standards: Familiarity with EN 62366, EN 60601, and EN 62304.
- Communication and Interpersonal Skills: Excellent communication (e.g., oral, written, presentation) and interpersonal relationship skills.
- Computer Software Proficiency: Proficiency in general computer software such as word processing, spreadsheets, presentations.
- Good Manufacturing Practices: Understanding of Good Manufacturing Practices (GMP).
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