Primary or Major Responsibilities:

• Responsible for the effectiveness and implementation of site Quality Management System consistent with ISO 13485:2003 and FDA requirements
• Management of receiving inspection and final quality inspection activities
• Management of internal audit and layered process audit programs and primary liaison for customer and other external audits
• CAPA and complaint management
• Oversight of Validation, Change Control, and Temporary Deviation activity
• Development and reporting of site Quality metrics and corrective action implementation
• Support customer domestic and international product registration requirements
• Monitors and manages Quality employees’ job performance.
• Ensures that all Quality employees are properly trained and cross-trained as required.
• Encourages, participates, and leads in continuous improvement activities such as Lean, Six Sigma, and Kaizen.
• All other duties as assigned.

Safety:

• Ensure that all assignments are performed in compliance with all applicable Federal, State, Provincial and Company safety and health regulations, and where applicable, proper personal protective equipment is utilized.

Minimum Requirements:

• Bachelors degree in Engineering or science-related field.
• 5 plus years experience as Quality Manager is the medical device industry or equivalent experience.
• Expertise in medical device laws and regulations (ISO 13485 and FDA CFR)
• Ability to manage a dynamic team of individuals.
• Expertise in software programs such as Windows Word, Excel, PowerPoint.
• Good communication and training skills

It is understood that certain minimum requirements are not tested for but monitored for competent capability during the employee’s indoctrination period.