Quality Manager - Westminster, United States - Inovonics

Description

• 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.

• Minimum 5 years' experience in ISO certified manufacturing environment
• Successfully led an organization through an ISO13485 certification process, including working with outside 3rd 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.

• Bachelor's degree in related field
• ISO13485 3rd party certification

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.