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

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
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)