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