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.
- 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.
- 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.Apply Now