Senior Quality Engineer

Overview

An innovative biotechnology company focused on breakthrough manufacturing technologies is seeking an experienced Senior Quality Engineer. This pivotal role provides hands-on involvement and significant influence in quality systems, design assurance, and supplier quality within a dynamic and rapidly evolving environment.

Key Responsibilities

• Maintain and enhance the Quality Management System (QMS), ensuring ongoing compliance and improvement.
• Handle change controls, deviations, CAPAs, and manage document control processes efficiently.
• Lead and coordinate internal audit programs and support external audits rigorously.
• Develop, review, and maintain standard operating procedures (SOPs), work instructions, and other quality documentation.
• Oversee supplier qualification processes, perform supplier audits, and manage Quality Technical Agreements.
• Critically evaluate supplier quality records such as batch records, validation documentation, and change notifications.
• Support design control operations throughout product development, maintaining Design History Files and related documentation.
• Participate actively in design reviews and verification and validation efforts.
• Manage risk assessment activities, including Design Failure Mode and Effects Analysis (FMEA).
• Assist product development initiatives through to successful commercial launch.
• Provide regulatory support including assistance with FDA and EU compliance, regulatory submissions, and contribute to Drug Master File (DMF) activities where applicable.

Qualifications & Requirements

• Minimum of five years’ quality assurance experience within the medical device industry.
• Comprehensive knowledge of Good Manufacturing Practices (GMP) and Quality Management Systems.
• Familiarity with ISO 13485 standards governing design controls.
• Experience managing relationships and quality requirements with suppliers and external manufacturers.
• Proven experience in conducting internal audits.
• Strong expertise in CAPA processes, deviation management, change controls, and risk management practices.
• Exceptional technical writing and documentation capabilities.
• Ability to work autonomously while juggling multiple tasks and priorities effectively.