Quality Assurance Manager

JOB SUMMARY:

The Quality Assurance Manager will provide overall company leadership and direction to meet customer quality requirements. This position will also create, monitor, and improve quality programs while reducing quality costs and maintaining compliance within FDA and ISO regulations. This is accomplished by utilizing Tecomet’s standards of Safety, Quality, Schedule and Customer Innovation

ESSENTIAL FUNCTIONS:

Promote and develop plans with Tecomet’s customers to certify Tecomet as a preferred supplier.
Develop and maintain customer relationships.
Assure consistent controls in the manufacturing process for continuous quality improvement and the reduction of quality costs.
Optimize manufacturing process run time by identifying and eliminating production failures.
Coach and provide training for Quality Engineers, Six Sigma Green Belts, and Quality Inspectors.
Measure the effectiveness of the systems in place, report back to upper management and develop assessments and corrective action plans.
Determine if a potential supplier has the basic systems and machine capabilities in place prior to placing an order with that supplier.
Develop and administer systems that facilitate the certification of suppliers, subsequently reducing and/or eliminating Tecomet’s receiving inspection time and cost.
Follow-up on all internal and external corrective action responses .
Internal & external audits and supplier approvals.
Oversee special processes validations.
Oversee gage control.
Device pre-sterile packaging and sterilization requirements.
Project a positive and professional image of the company and of management to employees at all levels .
Completes performance reviews for direct reports by required due date.
Additional functions and requirements may be assigned by management as deemed appropriate.

Knowledge of:

Receiving, in-process, and final inspection techniques
Developing inspection criteria
Quality audit processes and maintenance of master device history records
CMM Programming and inspection techniques
Gage and Calibration
Strong organizational skills
Strong people and leadership skills
Excellent verbal and written communication and listening skills
Problem solving and evaluation
Process improvements
Computer operation

Core technical skills:

Lean principles
Standard measuring devices
Geometric Dimension &Tolerance GD&T
Project management
Quality audit processes

Core education and experience:

Bachelor of Science Degree or related field.
Six or more years of experience.
Or equivalent combination of education an/or experience.

Preferred:

ASQ, CQE, CQA, and/or CQM
Knowledge of ISO/FDA Requirements

Working Conditions/Physical Abilities:

Well lighted, heated/or air-conditioned indoor office/production setting with adequate ventilation.
Light physical activity performing non-strenuous daily activities of a primarily administrative nature.
Ability to maneuver throughout the facility/facilities as needed.
Manual dexterity sufficient to reach/handle items and work with fingers.
Ability to wear proper PPE.

Equal opportunity employer as to all protected groups, including protected veterans and individuals with disabilities

Americans with Disabilities

The statements herein are intended to describe the general nature and level of work being performed by employees and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of the Company.