Responsibilities:
* Maintain the CAPA and Complaint systems and ensure that CAPAs/Complaints are reviewed and closed expeditiously.
* Participate in both internal and external audits.
* Support continuous product improvement efforts including performance of root cause analysis/corrective action implementation for customer complaints, manufacturing issues, cost reduction, and new product development.
* Participate in the definition, standardization, and implementation of best practices associated with the quality system and business processes.
* Define and/or execute test and inspection protocols, support validation activities, establish product acceptance standards and metrology, and integrate new products into data collection systems to facilitate process control and continuous improvement efforts.

* A Bachelor's degree in Engineering
* A minimum of 2-5 years of experience in a Quality Engineering role, preferably in the Medical Device field, with a demonstrated record of success in the competencies outlined above is required.
* Certification as an ASQ Certified Quality Engineer, Six Sigma Black Belt, or Certified Reliability Engineer is strongly preferred.
* Must have expertise in FDA/QSR, cGMPs, and ISO9001/13485.