Quality Engineer

Summary:
Quality Engineer to ensure compliance with applicable standards and regulatory requirements (e.g., FDA, ISO) and manage manufacturing quality operations supporting the production lifecycle (e.g., DHR, batch release, risk-based controls). This role also supports additional quality activities such as design controls, risk management, verification and validation, design changes, and design transfer, while developing and utilizing quality tools and supporting the development, implementation, and improvement of the Quality Management System (QMS). This role works within established procedures covering quality, environmental health and safety, confidentiality, and good manufacturing practices.

Roles & Responsibilities:

• Support and challenge the project team on all aspects of quality.
• Review and approve quality documentation in accordance with development procedures.
• Lead validation activities and ensure completion of DHR deliverables.
• Participate in project risk management activities, ensuring that tools such as the Risk Management Plan, Risk Management Report, and FMEA are properly used (product and process de-risking).
• Follow up and report project status regularly to the Unit Quality Manager.
• Participate in internal audits.
• Actively participate in QMS maintenance and improvement.
• Ensure quality of program documentation, including traceability.
• Ensure quality of the developed products.

Qualifications:

• Bachelor's or Master's degree in Engineering, Science, or a related field.
• 3+ years of experience working in quality departments for regulated industries such as pharmaceutical or medical device.
• Working knowledge of relevant regulations and industry standards (FDA 21 CFR 820, ISO 13485, etc.).
• Experience leading validation and documentation efforts within a manufacturing environment.
• Experience working on design control and risk management documentation for medical devices, combination devices, or pharmaceuticals.
• Familiarity with basic statistics, Gage R&R, and Design of Experiments.
• Self-motivated with good communication and organizational skills.