Quality Engineer III

Medix is currently partnered with a medical device services provider, partnering with leading medical device OEMs to bring life-saving equipment to market. They offer comprehensive support in manufacturing, new product introductions, supply chain management, design and development, material expertise, and assembly of complex components. Their services span various markets from diagnostics and laboratory products, drug delivery, orthopedics, respiratory/monitoring/patient care, and surgical technologies.

Position Purpose:

The Quality Engineer III will play a pivotal role in managing all aspects of customer specifications related to new automated assembly lines primarily focused on surgical robotic components. The role involves handling quality activities, managing change in product launches, and interfacing with customers to address complaints and investigations related to quality processes.

Key Responsibilities:

• Manage customer specifications and quality requirements for automated assembly lines.
• Oversee change management processes during product launches.
• Handle customer complaints and lead investigations, including root cause analysis and corrective actions (CAPAs).
• Utilize process quality and problem-solving methodologies, including NCR, CAPA, RCA, and failure analysis (FMEA).
• Implement quality tools such as Six Sigma, Fishbone Diagrams, 5Y/5 Why, TQM, and SPC.
• Ensure compliance with quality systems, including ISO 13485 and FDA regulations.
• Conduct ISO audits and facilitate correspondence with regulatory agencies, auditors, and customers.
• Perform data analysis using statistical process control (SPC) and tools like Minitab.
• Develop and maintain quality documentation, including control plans and validation protocols.
• Collaborate with cross-functional teams to drive operational excellence and lean principles.

Requirements:

• Bachelor's degree in relevant field
• 5 years of process-related quality experience
• Understanding of validations (IQ, OQ, PQ) and data analysis
• Proficiency in filling out quality documentation and control plans
• Experience handling customer complaints and leading investigations
• Advanced knowledge of quality tools and methodologies
• Familiarity with ISO 13485, FDA regulations, and ISO auditing
• Strong data analysis skills, including proficiency in Minitab

Compensation:

• Pay Rate: $90,000 - $115,000
• Benefits: 3 weeks vacation, 10 paid holidays, tuition reimbursement, career laddering program