Instrument Manufacturing Training & Quality Specialist Manager

Instrument Manufacturing Training & Quality Specialist Manager

This is a full time exempt position and under the guidance of the Director of Production. They will be responsible for the training, quality, and metric trending for employees in the manufacturing and assembly of clinical and commercial products. This person will be responsible for collecting and reporting training data to the head of the department and will also be responsible for maintaining the required updates of the departmental documentation and change control system. They will also be responsible for leading the team that will review documentation generated from the Instrument Manufacturing process to ensure that the quality of the product is in compliance with FDA regulations. This individual must have an extensive knowledge of commonly used cGMP concepts, practices, and procedures within the medical device manufacturing field. Relies on instructions and pre-established guidelines to perform the functions of the job. Works under immediate supervision and reports to the BFDX Production Director.
Principal Job Duties and Responsibilities:
Perform all work in compliance with company policy and within the guidelines of BFDX’s Quality System.
Working knowledge of the controls needed for the manufacturing of sub-assembly components and finished goods.
Trend and maintain manufacturing training, efficiency, and quality metrics.
Maintenance of Training Web for the department.
Managing the training and DHR review programs for the department.
Maintains records that comply with regulatory requirements, Good Manufacturing Practices, and Standard Operating Procedures.
Maintains through change control processes the departmental documentation program and updates documents as needed.
Ensures that all employees are appropriately trained for their respective job functions. Required to interact with various company departments.
Hiring, supervising, directing discipline and training of supervised personnel.
Responsible to track employees’ times and scheduling of time off.
Performs additional job functions as directed by the Production Director.
Principal Decisions:

Coordination of Instrument Manufacturing with the supervisors/manager’s input.
Qualifications

Training and Education:
Requires an Associate’s Degree, vocational training or equivalent.
Experience:
Ability to use specialized equipment, read instructions, maintain written records, work from established drawings. Must be able to be certified to a Manufacturing Technician III level to be considered. Prior training, quality, and supervisory experience would be considered critical to this position.
Skills:

Intermediate mathematics skills. Familiarity with ESD programs and clean room manufacturing desired. Experience with electronic or electro-mechanical assembly as well as trouble-shooting methods and concepts. Demonstrate a working knowledge of computer usage, such as Windows, Power Point, Word and Excel,basic MRP systems, etc. Additionally the following skills would be beneficial:
Leadership skills to effectively direct employees while in a training class environment and ability to properly evaluate comprehension and application of subject material
This position must be able to react positively to a changing environment helping to lead the way forward to include new developments in training and DHR Review targeted to both new and existing employees
Ability to communicate professionally with all levels of employees
Excellent written and oral communication skills are necessary to produce and deliver quality training programs
High-level of effective interpersonal communication skills, both written and verbal plus organization and presentation skills
Salt Lake City,UT,États-Unis
Manufacturing
Salt Lake City,UT,États-Unis
Manufacturing
Salt Lake City,UT,États-Unis
Manufacturing
Salt Lake City,UT,États-Unis
Manufacturing

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