Senior Quality Engineer – Contractor

Role Overview

• Act as quality lead for major design and manufacturing projects, ensuring robust risk management and compliance.
• Own and optimize quality system processes (e.g., CAPA, supplier quality, complaint handling, statistical techniques).
• Lead complex investigations and implement systemic corrective/preventive actions.
• Provide expertise in reliability engineering, process validation, and design for quality.
• Represent the company as a quality expert during FDA inspections, notified body audits, and supplier audits.
• Collaborate with executive leadership to align quality strategies with business objectives.
• Mentor and coach quality engineers across multiple sites or functions.

Requirements

• Bachelor’s or Master’s degree in engineering, life sciences, or related discipline.
• 8+ years of progressively responsible quality experience in the medical device industry.
• Deep knowledge of global regulatory standards (FDA QSR, ISO 13485, EU MDR, MDSAP).
• Proven success leading cross-functional projects and influencing at senior levels.
• Advanced statistical analysis, risk management (ISO 14971), and Six Sigma Black Belt preferred.
• Track record of leading successful audits and remediation projects.
• Certification AATB or CTBS Certification, preferred
• Lead Auditor Certification, preferred
• ASQ – CQE, CBA, or CQA, preferred
• Excellent verbal and written communication
• Technical writing
• Problem solving methodologies
• Microsoft Office Suite
• Quality Management System software
• Investigations
• Statistical techniques

Benefits

• Up to 25% travel including international