Quality Director

 

Salary Range $150k-$165k

POSITION TITLE:                                 Quality Director

 

POSITION REPORTS TO:                     VP Operations and Supply Chain

 

SUMMARY OF POSITION:     

This position is responsible for assuring quality in all phases of the design and manufacturing processes.

 Additionally, this position will lead the organizations efforts to reimplement a Quality Management System (QMS) and review opportunities to implement ISO13485 compliant practices across the entire organization’s activities.

DUTIES AND RESPONSIBILITIES:


* Lead efforts across the entire organization to launch a QMS system.


* Work closely with the operations/supply chain/engineering organizations to deploy the QMS in both the product design and manufacturing processes.


* Lead the product and process validation activities


* Evaluate the opportunity to deploy ISO13485 compliant processes where applicable


* Establish and monitor and drive quality and reliability metrics to identify adverse trends and lead corrective actions.


* Lead the investigation/resolution of RMA’s from the field, leveraging the Design Engineering, Customer Service, and Manufacturing Engineering personnel


* Make recommendations to integrate best practices and lessons learned from First Article activities to ensure consistent reproducibility with minimal defects.



* Drive continual improvement through the use of quality tools including FMEA, control plans, SPC, etc.


* Maintain corrective and preventive action program.


* Develop procedures, work instructions, flowcharts, forms, templates, checklists, worksheets to ensure process compliance.


* Organize and perform periodic Internal and External Quality System Audits.


* Maintain failure reporting and corrective action system.

 

QUALIFICATIONS:


* Minimum 5 years’ experience in ISO certified manufacturing environment


* Successfully led an organization through an ISO9001 / 13485 certification process, including working with outside 3^rd party assessment organizations


* Demonstrated experience leading the deployment of CAPA processes including use of DFMEA/PFMEA, Root Cause/Corrective action programs.


* Certifications in Lean/Six Sigma/SPC or other quality control methodologies preferred.


* Highly motivated self-starter with the desire for continuous improvement.


* Excellent communication skills with respect to quality programs including effective tracking, analyzing, reporting, and problem solving.


* Understanding and interpretation of technical documents including drawings and specifications, technical writing as well as computer literacy.

 

EDUCATIONAL REQUIREMENTS:


* Bachelor's degree in related field


* ISO 3^rd party certification

 

COMPENSATION:

Salary Range $150k-165k

 

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