Senior Quality Engineer

Key Responsibilities

• Lead CAPA investigations and risk assessments for new and existing products.
• Demonstrates strong project management skills by effectively leading CAPA, product, and process improvement initiatives from initiation through sustained implementation, delivering measurable business impact.
• Demonstrates strong expertise in validation, including protocol development, execution, and lifecycle management for equipment, processes, and systems in compliance with regulatory requirements.
• Support daily manufacturing activities and resolve line issues.
• Develop and maintain quality systems, procedures, and documentation.
• Provide technical support for incoming inspection and lot release testing.
• Manage customer complaints and non-conformance investigations.
• Lead internal and external audits (FDA, ISO, MDD).
• Oversee supplier quality activities including audits and corrective actions.
• Support engineering teams in product development and process improvements.
• Conduct statistical analysis, validation testing, and Gage R&R studies.
• Mentor junior quality staff and provide training as needed.

Qualifications

• Bachelor’s degree in engineering, science, or related technical field.
• Minimum 8 years of quality engineering experience in regulated industries (medical device or pharmaceutical preferred).
• Experience with ISO 13485, ISO 14971, FDA QSR, IEC 60601, and related standards.
• Proficiency in statistical tools and software (Minitab preferred).
• ASQ certifications (CQE, CQA) and Six Sigma Green/Black Belt preferred.
• Demonstrates working knowledge of sterilization methods and controls and their impact on product quality, including validation, change control, and compliance requirements (preferred).
• Excellent communication, technical writing, and project management skills.
• Ability to travel up to 10%.