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QA Compliance Specialist

3 months ago

Warren, United States Merit Manufacturing Full time

Summary

Responsible for the general compliance of Merit's Quality System to regulatory and industry requirements, ensuring improvements are tracked then trended, support external audits with oversight on internal audits, and support various quality functions.

Essential Functions include but are not limited to the following:

  • Managing non-conformances, deviations, CAPAs, and DMRs
  • Support validation program
  • Assist in regular quality system review and updates
  • Keep track of Scorecard for all departments training of SOPs on a monthly basis
  • Regular review of current industry compliance trends
  • Oversee the internal audit program
  • Support continuous improvement initiatives
  • Support supplier qualification program
  • Perform root cause analysis of various non-conformances and out-of-specifications
  • Other duties as assigned

Skills/Knowledge/Abilities

  • Must have a High School Diploma or equivalent (Bachelor's Degree preferred)
  • 2 years of compliance or regulatory experience
  • Excellent critical analysis skills
  • Excellent verbal communication skills
  • Speak and write English
  • Basic mathematical skills
  • Basic computer skills

Physical Demands

  • Sitting 50%
  • Walking 60%
  • Standing 30%
  • Visual Acuity
  • Ability to lift and pull minimum of 40lbs.
  • Bending, pulling, pushing, reaching, above shoulder/below waist
  • Speaking - Ordinary speech
  • Hearing - Ordinary conversation
  • Fingering - Computer keyboard


What you get for your Hard Work:

Pay: Starts at $23-25/hr

Benefits:

  • Healthcare
  • Dental
  • Flexible Time Off Policy
  • Performance Bonus Opportunities
  • Year End Bonus Opportunity
  • Company events

Equality:

Merit Manufacturing is committed to the full inclusion of all qualified individuals. All qualified applicants will receive consideration for employment without regard for race, religion, disability, age, sexual orientation, gender identity, national origin, veteran status, or genetic information.