Quality Manager

Salary Range $120k-$130k

 

POSITION TITLE:                          Quality Manager

 

POSITION REPORTS TO:             VP Operations and Supply Chain

 

DUTIES AND RESPONSIBILITIES:


* Lead efforts across the organization to launch ISO13485 compliant practices/procedures to achieve ISO13485 certification.


* Work closely with contract manufacturing partners to launch ISO13485 compliant processes in the manufacture of Inovonics products.


* Work closely with cross-functional teams to implement and maintain effective processes and procedures to ensure high quality output.


* Establish and monitor quality and reliability metrics to identify adverse trends requiring actions.


* Work closely with and/or lead teams of Design Engineering and Manufacturing Engineering personnel to drive root cause and corrective action solutions.


* Ensure effective use of data and problem-solving techniques to maintain a technically sound and responsive Quality Assurance system.


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


* Develop and implement a Failure Modes and Effects Analysis (FMEA) in both the design and manufacture of products, leveraging our Contract Manufacturing partners.



* Define and deploy metrics program to identify process improvement opportunities.


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


* Develop and implement process verification and validation plans.


* 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 ISO13485 certification process, including working with outside 3^rd party assessment organizations


* Demonstrated experience leading the deployment of CAPA processes including use of FMEA, 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


* ISO13485 3^rd party certification

 

COMPENSATION AND OTHER

Salary R...