Senior Quality Engineer

You will establish quality requirements across product development and manufacturing. You will support verification and validation, risk management, inspections, supplier quality, CAPA, audits, packaging and labeling compliance, and maintenance of quality records and regulatory documentation.

Responsibilities

• Establish quality requirements for product and process development and manufacturing
• Support product verification and validation activities and create protocols and reports
• Maintain the risk management process and Risk Management File
• Maintain the Design History File and Device Master Record
• Set up receiving inspection and perform incoming, first-article, and final-product inspections
• Document product discrepancies and follow up on nonconformance closure
• Manage supplier qualification, the Approved Suppliers List, and supplier corrective actions
• Manage CAPA from generation through effectiveness verification and closure
• Support internal and external audits
• Ensure packaging and labeling conform to applicable regulations

Requirements

• Bachelor’s degree in engineering, life sciences, or a related field
• At least 5 years of quality engineering or related medical device industry experience
• Experience with design control
• Knowledge of QSR, MDR, and ISO regulatory requirements
• Problem-solving skills
• Written, verbal, and organizational communication skills
• Ability to teach quality tools and problem-solving techniques

Benefits

• Company-paid benefits package