This is a highly responsible, independent and supervisory position responsible for all aspects of the quality improvement process. This position requires strong medical manufacturing, customer relations, organizational, and leadership skills as well as a working knowledge of quality control measures and quality control programs in an ISO 13485 environment.

Adheres to and all safety and quality requirements including, but not limited to: Quality Managment Systems (QMS), Environment Management Systems (EMS), company policies and operating procedures, and other regulatory requirements.

Organizes and leads regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.

Coach, mentor, develop, direct, train and evaluate the work of the quality improvement personnel.

Develops and maintains internal/external relationships with key customers, divisions, and departments in order to strengthen and maintain business operations and growth.

Manage customer complaint and reject process to ensure accurate root cause analysis, timely response, determination and implementation of corrective actions.

Monitor site quality metrics and develop countermeasures as needed.

Provides training in the area of root cause tools, statistics, and quality systems.

Other projects and tasks as assigned.

Experience leading conversations with customers and auditors.

Ability to think strategically with the capability to advise the resolution of technical problems using innovative ways.

Work with diverse teams, guide teams through decision making, facilitate agreement, build collaborative relationships, and focus on customer needs.

Practical application experience in continuous improvement methodologies to improve processes, strengthen quality and drive efficiency.

Highly skilled in Quality tools e.g. FMEA, PPAP, Risk Analysis, Root Cause Analysis.

Advance proficiency in statistical tools (i.e. Gage R&R, Capability Analysis, Anova, etc.)

Ability to read and interpret drawings.

Experience and demonstrated advanced proficiency in Process Validation (IQ, QQ, PQ, TMV)

Proficiency in Risk Management

Detail oriented with strong orgnaization skills

Ability to work cross functionally and as part of a project team

Self-Motivated and strong ability to adapt to change

Requirements

Minimum Education: BS in Engineering or applicable technical fields. Masters degree is a plus!