Quality Control Specialist

Purpose and role of job:
Responsible for the scientific review and analysis of Quality Control systems, providing technical support for other quality related functions.
Principal Accountabilities/ Responsibilities:

• Perform one or more assigned quality responsibilities, including:
  • Control of quality documents, records and standards
  • Participation in internal auditing of the quality system, processes, and products
  • Maintenance of test and measurement instruments in a calibrated condition
  • Participation in the calibration of specific tooling purchased by FQP
  • Provide training in quality systems to QA staff and other functions
  • Participation in processing and analysis of complaints, nonconforming goods, and corrective/preventive action requests
  • Participation in the validation of equipment and processes
  • Maintenance of quality records
  • Maintenance of regulatory and compliance records
  • Microbiological and environmental monitoring related to product quality
  • Competitive product analysis
  • Other specialized product testing and evaluation
• Devise/revise procedures and work instructions related to the quality system
• Provide recommendations for improvements to the quality system, testing methods, equipment, and potential cost savings
• Report on trends in product quality and provide analysis of possible contributing factors
• Assist with process capability studies aimed at establishing product specifications, achieve improvements in product quality, or product cost savings
• Understand FDA, ISO and other applicable standards and regulations
• Work with and lead teams in performing quality-related investigations
• Assist or substitute for the QA Manager with other responsibilities, as requested

Education and experience requirements:

• Familiarity with formal quality systems required
• Working knowledge of statistical analysis including SPC/SQC preferred
• Familiarity with computer applications (Microsoft Office or equivalent)
• Attention to detail, good communication skills, team leadership ability
• Associates degree in Science, Management, or Technology field and 2+ years' experience in a Sr. quality or technical position
• ASQ Certification (CQA, CQT, CMI) or equivalent body of knowledge transferred.

First Quality is committed to protecting information under the care of First Quality Enterprises commensurate with leading industry standards and applicable regulations. As such, First Quality provides at least annual training regarding data privacy and security to employees who, as a result of their role specifications, may come in to contact with sensitive data.
First Quality is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, sexual orientation, gender identification, or protected Veteran status.