Overview
Quality Director Jobs in Westminster, Colorado, USA at Inovonics
POSITION
***** Quality Director
POSITION REPORTS
***** VP Operations and Supply Chain
SUMMARY OF **
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 ISO
13485 compliant practices across the entire organization’s activities.
DUTIES AND *
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 ISO
13485 compliant processes where applicable.
Establish, 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.
*
Minimum 5 years’ experience in ISO certified manufacturing environment.
Successfully led an organization through an ISO
9001 / 13485 certification process, including working with outside 3rd 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 *
Bachelors degree in related field.
ISO 3rd party certification.
****
Salary Range $150k-165k
Inovonics values diversity of thought and background and provides equal employment opportunity to all qualified applicants without regard to race, color, religion, national origin, gender, sexual orientation, age, veteran status, or disability.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities.
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Title: Quality Director
Company: Inovonics
Location: Westminster, Colorado, USA
Category: Engineering, Quality Assurance – QA/QC
