QUALITY SYSTEMS MANAGER
Oversees all aspects of the organization's quality system and improvement efforts, such as developing, implementing and administrating the program, training and coaching employees and facilitating needed changes in the organization. Responsible for establishing policies and procedures at all levels to ensure quality improvement efforts will meet or exceed internal and external customer needs and expectations. Ensures the promotion of awareness of customer requirements throughout the company. Responsible for dealing with customers and suppliers on quality or performance issues.
DUTIES AND RESPONSIBILITIES
Is the company Management Representative responsible for implementing, establishing and maintaining the company quality system in accordance with ISO13485 / 21CFR820 and other specifications as required, ensures the company meets any other additional customer specific requirements. Represents the company as the liaison with external parties regarding the company quality system and its’ capabilities.
Responsible to facilitate management review meetings and report on the performance of the quality system and its’ metrics.
Is a certified Lead Auditor responsible for the company internal audit program in compliance with ISO13485 / 21CFR820 and other specifications as required. Conducts QMS, Process and Final Product Audits.
Manage Internal Corrective Actions (ICAR): manage log, issue ICARS, assist in corrective actions and verify effectiveness of corrective actions through auditing.
Interfaces with customers, sales, manufacturing and engineering to resolve quality and contractual issues.
Manages the corrective action process in molding, including facilitating and leading corrective action teams, maintains dialogue and correspondence with customers and suppliers, controls records regarding corrective actions. Assists and facilitates corrective action teams in stamping upon request.
Facilitates company quality system related training programs, gives on the job instruction and presentations as needed. Coordinates diverse training needs with outside consultants. Obtains outside funding for training (NJ Customized Training) as needed.
Provides guidance and training to quality, manufacturing or engineering groups in the use of automotive core tools: APQP; FMEA, Control Plans, MSA, Statistical Techniques and PPAP.
Supervises Quality Manager, Quality Engineer and Supervisor. Backups Quality Engineers/Supervisors during their absences and periods of high volume covering manufacturing, incoming inspection, engineering and customer issues.
Maintains and is responsible for the company’s document control system. Responsible for the maintenance of the Master Databases on the company network used to control company documents.
Maintains and controls the company ISO13485 / 21CFR820 Training records for all company team members. Responsible for the maintenance of Master training databases on the company network.
Manages the company Motivation and Empowerment Program including maintenance of the database.
Interpret blueprints and specifications related to geometric tolerancing, gauging, statistical requirements and related specifications. Provide interpretation and guidance within the quality group and to manufacturing and engineering departments.
Four year college degree.
5 years experience in Quality Control/Assurance in a tightly toleranced industry with an automotive and medical customer base.
Requires verbal and written communication skills and the ability to communicate technical information to people of various degrees of ability.
Must be organized and detail oriented.
Must possess the project management skills to manage and implement small to large projects.
Needs a thorough understanding of automotive and medical industry quality requirements (APQP, FMEA, Process Flows, Control Plans, Measurement System Analysis).
Knowledgeable in the following Military Specifications: MIL-STD-45208A, MIL-STD-45662, MILQ9858A. Requires training in and thorough understanding of ISO13485 / 21CFR820
Must have general knowledge and training in the principles related to metals or resins. Individual must be proficient in blueprint interpretation, geometric tolerancing and statistics.
Must be computer literate in MS Office (Word, Excel, Powerpoint).
Requires understanding of the capabilities and practical uses of various types of measuring equipment: basic mechanical instruments, complex programmable vision systems and computerized data collection systems.
We provide excellent company benefits and a competitive salary. We are an equal opportunity employer. Currently only accepting local candidate submissions.
This position is for our Weiss-Aug Fairfield | NJ location.