Quality Assurance Manager

Responsibilities


  • Responsible for the company’s Quality Management System, including ISO 9001 and 17025.
  • Responsible for processing audit CAPAs, including effectiveness checks through closure. Perform all appropriate follow-up activities to ensure CAPA closure within a timely manner.
  • Prepare Key Performance Indicator reports and present status in review meetings.
  • Plan and coordinate quality assurance programs and develop quality control policies.
  • Maintain Standard Operating Procedures (SOPs) and ensure their compliance to ISO 9001/17025 requirements and the business’s policies.
  • Audit existing procedures and revise as needed and implement through training.
  • Understand and monitor all operations that affect quality, perform gap analysis, and devise and implement improvement plans.
  • Conducts audits of suppliers as needed.
  • Keep abreast of the ISO changes & enhancements and educate the business on compliance requirements.

Qualifications


  • Working knowledge of ISO 9001 and 17025 Quality Procedures.
  • Recent experience facilitating ISO 9001 and 17025 audits.
  • Excellent communication skills. Demonstrated ability to articulate ideas clearly and concisely in verbal and written form.
  • Experience with current Good Manufacturing Practices (cGMP) is a plus.
  • Experience integrating acquired companies into an ISO-certified organization.
  • Bachelor’s degree in science (chemistry, analytical chemistry biochemistry, biotechnology, or similar) or equivalent lab experience
  • Knowledge of lab practices, standard concepts, and test procedures for analytical instruments
  • In-depth knowledge of Quality System Processes
  • MS office skills required.
  • Ability to lift 50 pounds.
  • A valid driver’s license in good standing is mandatory.

About Full Spectrum Group:

Full Spectrum Group (FSG) is a dynamic company consisting of veteran service engineers, software specialists, and application chemists. FSG specializes in the service, repair, and validation of a wide range of instrumentation including Gas, Liquid, and Ion Chromatography Systems, Mass Spectrometers, Purge-and-Trap, Headspace Units, and Total Organic Carbon Analyzers.

Over the past 25+ years, FSG has worked with many Manufacturers and Distributors to assist with their service needs. The Full Spectrum Group service team consists of individuals with diverse backgrounds relating to analytical instrumentation, many of them being former service representatives for the manufacturer or product development managers. New employees undergo an extensive in-house training program in addition to attending manufacturers’ training courses.

Full Spectrum Group is an ISO 9001:2015 & ISO/IEC 17025:2005 accredited organization. These standards require a comprehensive quality management system that includes a company-wide commitment to outstanding customer satisfaction, traceable documentation, organizational planning, and continually improving quality standards.

As we continue to improve our quality system with these global standards, we believe that our decision to become ISO Certified is a proactive one that anticipates our customers’ demands and demonstrates our dedication to providing superior laboratory support and services to all our customers.

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