Job Description

Position Overview:

The Senior Quality Engineer ensures compliance with regulatory requirements (FDA QSR, ISO 13485, ISO 14971) and company procedures, contributing to both development and production teams to meet customer, company, and regulatory standards. The role includes process development, quality support, risk assessments, root cause analysis, and continuous improvement efforts.

Key Responsibilities:

• Ensure adherence to Quality Management System (QMS) and regulatory standards.
• Provide support to either the Development or Production teams, ensuring product manufacturability, process qualification, and regulatory compliance.
• Develop, validate, and execute test methods, standard work, and process controls for new and existing products.
• Conduct risk assessments, quality plans, control plans, and root cause analyses to resolve issues and improve processes.
• Support process improvement, nonconformance investigations, customer complaints, and supplier quality issues.
• Lead or participate in Lean and continuous improvement initiatives.
• Communicate effectively with internal teams and customers to ensure quality standards are met.
• Collaborate across teams (Development, Production, Quality, Sales, etc.) on regulatory documentation and corrective actions.
• May serve as a subject matter expert for external audits and internal audits.

Training & Experience:

• Bachelor's degree in science, engineering, or related field (for Sr. QE level); Associates Degree with relevant experience for lower levels.
• Experience in the medical device industry or similar fields, with proficiency in statistical techniques, data analysis, and technical writing.
• Strong verbal and written communication skills with internal and external stakeholders.

Skills & Attributes:

• Strong attention to detail and organizational skills.
• Ability to manage multiple projects simultaneously.
• Proficient with Microsoft Office, ERP, and statistical software (e.g., EPICOR, Minitab).
• Critical thinking and problem-solving abilities.
• Independent, self-starter with a team-oriented approach.

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