QSpex Technologies, Inc.

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Manager, Quality Policy & Regulatory Affairs

at QSpex Technologies, Inc.

Posted: 6/2/2019
Job Reference #: 105

Job Description

Alpharetta, GA


QSpex Technologies, Inc.

Job Description

Position Title: Manager, Quality Policy & Regulatory Affairs

Reports To: President & CEO

Department: Quality

FLSA: Exempt

Location: Alpharetta, GA

Job Summary:

Responsible for leading the Quality Policy and Regulatory Affairs efforts within the organization. Incumbent will be responsible for driving continual process and product improvement throughout the organization and ensuring product and process integrity leading to customer satisfaction and overall mission success. This is a hands on, highly involved leadership position. 

Essential Functions:

  • Develop, implement, manage and integrate a QMS for manufacturing plants.
  • Serve as the primary quality control resource for problem identification, resolution, loss reporting and continuous improvement.
  • Manage quality control personnel on a day-to-day basis.
  • Support concurrent engineering efforts by participating in design development projects representing quality assurance and the customer.
  • Design, implement and document procedures for process control, process improvement, testing and inspection.
  • Establish and implement metrics (process capability, control charts, measurement quality) for monitoring system effectiveness and to enable managers to make sound product quality decisions
  • Perform root-cause analysis and other problem solving activities to identify effective corrective actions and process improvements.
  • Establish collection and analysis systems of statistical data to predict trends that will affect improvement of product quality.
  • Develop quality planning methods for all product lines.
  • Develop process certification standards and assist in process certification.
  • Oversee calibration and testing programs.
  • Report to management on quality issues, trends and losses.
  • Participate in internal and external quality audits.
  • Interface with supplier and customer quality representatives concerning problems with quality control and assure that effective corrective action is implemented.
  • All other reasonable duties, as assigned.

 Knowledge, Skills and Abilities:

  • Demonstrated ability to effectively manage multiple tasks
  • Must be self-motivated
  • Strong organizational skills and excellent attention to detail and follow-through
  • Expert knowledge of contemporary quality assurance practices
  • Experience with strategic and quantitative analysis – ability to gather and interpret data
  • Ability to critically evaluate and troubleshoot complex problems is essential.
  • Strong hands on leadership and management skills.
  • Ability to effectively participate on multi-disciplinary teams.
  • Ability to absorb, digest and relate detailed scientific, quality, and regulatory information.
  • Well-organized and detailed oriented professional, with strong verbal, written, and interpersonal communication skills.
  • Experience leading internal audits and participating in external FDA audits.
  • Well-organized and detailed oriented professional, with strong verbal, written, and interpersonal communication skills.

Minimum Qualifications:

  • Bachelor’s Degree in Engineering, Quality Systems or related field required
  • Master’s Degree preferred
  • Required: 10-15 years’ experience in a lens manufacturing and quality assurance environment within the optical industry
  • Medical device background and FDA audit experience a plus

Working Environment

Work performed in an office and factory settings. Exposure to laboratory environment.  Occasionally required to lift up to 20 lbs.  Regularly required to sit, stand, bend, reach and move about facilities.

Employee will primarily work regular business hours, but may sometimes be required to work extended hours including evenings and weekends and may be required to travel outside the office to attend meetings.  Employees may work under the stress of regular interdepartmental contacts and pressure to meet various reporting deadlines.

This position description does not constitute an employment agreement between QSpex and employee and is subject to change by the Company as the needs and requirements of the position change.  The position description is intended to describe the general nature and level of work being performed by people assigned to this classification, and should not to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.  All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.