SUMMARY  

Responsible for all aspects of the development and implementation of the quality system including preventive and corrective actions, non-conformance control, and continuous improvement and quality system effectiveness.  Provides a single point of contact for those projects to the General Manager and President.  

 ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.  

• The Quality Manager is responsible for the development, documentation, implementation and registration of the Quality Systems for ISO9001, IATF16949 and ISO13485.  This position is the Management Representative as defined in ISO9001, IATF16949 and ISO 13485.
• Leads medical validation efforts including IQ, OQ and PQ activities in accordance with ISO 13485 standards
• Provide procedural, strategic and policy guidance in written and verbal form related to the quality systems and assigned other assigned initiatives. Reviews and maintains quality systems to assure continued compliance.
• Conduct training and monitoring activities to ensure adherence to quality standards and procedures by employees and suppliers.   Maintains and enforces authority for self and all members of organization the ability to stop production due to quality requirements.
• Manage and supervise the Quality staff in the execution of daily responsibilities.  
• Champion the internal audit system including the selection and training of internal auditors.  Experienced in customer audits, specifically VDA6.3
• Develop performance metrics tracking and reporting system for manufacturing and business process quality.
• Champions customer quality and champions Company’s needs from customers for documentation and information to support the development of customer requirements.
• Develops a working relationship with customers to understand their current and projected requirements for quality of products and services.
• Lead MRB committee to quickly disposition non-conformances.  Initiate corrective action requests as required.
• Coordinates and administers document control activities as required by the standard.
• Set, monitor and report on the status of monthly and annual quality improvement goals to support Interplex corporate requirements. 
• Leads ISO14001 registration process and necessary environmental controls.   

QUALIFICATIONS    

To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  

EDUCATION and/or EXPERIENCE

Bachelor of Arts or Science Degree or Higher, and job-related experience, including strong experience and background of quality systems and their mechanics in a medical and automotive manufacturing environment.  

Automotive manufacturing experience required including competency in AIAG core tools, LPA’s and RFMEA’s.

Six sigma black belt and lean experience / certification preferred.  

LANGUAGE SKILLS  

 Ability to read, analyzes, and interprets common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to write speeches and articles for publication that conform to prescribed style and format. Ability to effectively present information to top management, public groups, and/or boards of directors.   

MATHEMATICAL SKILLS

Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.  

REASONING ABILITY  

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.  

CERTIFICATES, LICENSES, REGISTRATIONS: Quality certification and ASQ membership preferred.   

PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel and talk or hear. The employee frequently is required to sit and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, and ability to adjust focus.   

WORK ENVIRONMENT   

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  

While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts. The noise level in the work environment is usually quiet.