Quality Manager

JOB SUMMARY:

Performs management level quality control work. Manages all aspects of quality including maintaining applicable certifications, managing customer complaints, conducting inspections, programming machines, and participating in audits. Position requires an extensive depth of expertise and knowledge in specialized functions or business areas that can be used to develop policies and procedures as well as determining efficient and innovative ways to accomplish business strategies.

EXAMPLES OF ESSENTIAL FUNCTIONS:

The list of essential functions, as outlined herein, is intended to be representative of the tasks performed within this classification. It is not necessarily descriptive of any one position in the class. The omission of an essential function does not preclude management from assigning duties not listed herein if such functions are a logical assignment to the position.

·Manages, schedules, and prioritizes work load inspections, First Article Inspections (FAI’s), and Coordinate Measuring Machine (CMM) programming

·Manages, documents, tracks, and trends customer complaints, non-conformances, and Corrective And Preventive Actions (CAPA’s)

·Manages process validations, special requirements capability studies, Gage Repeatability and Reproducibility (R & R), and other statistical analysis as required by the customer

·Manages quality system procedures, forms, and work instructions; maintains International Organization for Standardization (ISO) 13485 registration

·Manages calibration systems, gage calibration

·Manages Engineering Change Orders (ECO’s), customer revision changes, disposition of Work in Process (WIP), and inventory

·Authorizes the Material Review Board (MRB) to dispose of items

·Performs inspection of parts and sorts customer parts on an as needed basis

·Coordinates internal and external audits using external and internal resources; hosts customer audits

·Responsible for HR administration tasks utilizing the Human Resources Information System (HRIS)

Supervision:

·Plans and coordinates the department’s work plan; assigns projects and programmatic areas of responsibility; reviews and evaluates work methods and procedures, meets with management staff to identify and resolve problems

·Assesses and monitors workload, administrative and support systems and internal reporting relationships; identifies opportunities for improvement; implements changes

·Selects, trains, motivates, and evaluates personnel; provides or coordinates staff training; collaborates with HR regarding employee relations issues; works with employees to correct deficiencies; implements discipline and termination procedures

MINIMUM QUALIFICATIONS:

Technical certificate or associate’s degree in programming/process engineering or related field; supplemented by eight or more years’ experience in quality control, including three years of supervisory experience; or an equivalent combination of education, certification, training, and/or experience. Must have or be able to obtain Lean training, Black Belt training, and Geometric Dimensioning and Tolerancing (G D & T) training.

KNOWLEDGE, SKILLS, AND ABILITIES:

·Advanced knowledge in the field of engineering and geometric dimensions and tolerances

·Detailed knowledge of measuring tools, including but not be limited to, calipers, micrometers, depth gages, indicators, and plug and tread Go/No Go gages

·General knowledge and understanding of ISO 13485 and FDA 21CFR820 as it pertains to the job, on the job training provided

·Skilled in the use of computer software including but not limited to Microsoft Outlook, Word, and Excel, Adobe PDF, SolidWorks, in-spec metrology software, and Enterprise Resource Planning (ERP) systems

·Skilled in basic math including but not limited to adding, subtracting, multiplication, division, geometric construction, practical algebra and metrics for the purpose of calculating material specifications

·Skilled in setting priorities that move projects through efficiently to achieve customer and quality objectives

·Skilled in maintaining focus and quality in changing work environment, competing demands and ability to deal with frequent change, delays or unexpected events

·Ability to use reasoning skills that minimize duplication of efforts, including but not limited to comparing, classifying, analyzing and coordinating

·Ability to plan and problem solve creatively demonstrating sound judgment; utilize root cause analysis and develop corrective action plans

·Ability to delegate, organize and motivate personnel effectively

·Ability to establish and maintain effective and cooperative working relationships with those contacted in the course of work

·Ability to clearly communicate and understand information in English, both orally and in writing