Quality Engineer

We are seeking a Quality Engineer (Projects) to play a critical role in ensuring that new products, equipment, and processes are introduced into the manufacturing environment with the highest level of quality and compliance. This position works within a cross-functional team to provide comprehensive Quality Engineering support throughout the project lifecycle, ensuring adherence to regulatory standards and project timelines.

This is a 12 month contract position.

Key Responsibilities:

• Provide dedicated Quality Engineering support for critical site projects, including new product introductions (NPI), product transfers, and significant equipment/process changes.
• Ensure project compliance by serving as the Quality lead within cross-functional teams and adhering to strict regulatory standards and project timelines.
• Manage and approve validation documentation, including editing, reviewing, and approving documents such as MVP, URS, FMEA, IQ, OQ, PQ, and MVR.
• Support the quality aspects of manufacturing footprint changes, such as the relocation of production lines or the introduction of new manufacturing equipment.
• Lead or support root cause analysis (RCA) activities to effectively resolve problems and contribute to corrective and preventive action (CAPA) implementation.
• Communicate and report project status, deliverables, and any critical issues to the Quality Lead, internal team, and global functions in a timely and accurate manner.

Preferred Qualifications:

• Bachelor's degree in Engineering, a related Science field, or equivalent experience.
• Minimum 3+ years of relevant experience in the medical device industry
• Proven expertise in new equipment introduction, technical transfer, PPQ execution, and lifecycle management.
• Strong knowledge of validation principles (IQ, OQ, PQ) and quality systems (e.g., ISO, FDA regulations).
• Excellent documentation, technical writing, and problem-solving skills.
• Excellent organizational, communication, and collaboration skills.
• Critical thinking and problem-solving abilities.