Hiring: Quality Manager Company: Quest Products, LLC Location: Phoenix, AZ Job Posted Time: 2026-09-11 11:53:46 Employment Type: Contract / On-site Target Skills & Keywords : Quality Assurance, R, Root Cause Analysis About the job Experience: •5 years of progressive quality assurance/quality control experience in an FDA-regulated manufacturing environment (OTC drug, prescription drug, medical device, or closely related regulated industry). Required Skills: •Review and approve executed batch production records, in-process test results, and finished product testing prior to product release, ensuring compliance with approved specifications and cGMP requirements. •Own and maintain the site's Quality Management System, including SOPs, batch record templates, specifications, and validation documentation. •Manage the deviation, out-of-specification (OOS), out-of-trend (OOT), CAPA, and change control systems; ensure timely investigation, root cause analysis, and effectiveness checks. •Own the product complaint handling process, including intake, investigation, trending, and determination of reportability. •Lead and coordinate internal audits/self-inspections and support external audits, including FDA inspections, customer audits, and third-party certification audits; own responses to audit observations and FDA Form 483 findings. •Manage supplier and contract manufacturer quality oversight, including supplier qualification, quality agreements, incoming material inspection/testing programs, and supplier corrective action requests (SCARs). •Oversee equipment, facility, and process validation/qualification activities (IQ/OQ/PQ) and cleaning validation, in coordination with Operations and Engineering. •Maintain the site's document control system, including SOP lifecycle management, training records, and controlled document distribution. Qualifications: •Bachelor's degree in a scientific, engineering, or related technical discipline (e.g., Chemistry, Microbiology, Biology, Chemical Engineering) required. •Minimum 3–5 years of progressive quality assurance/quality control experience in an FDA-regulated manufacturing environment (OTC drug, prescription drug, medical device, or closely related regulated industry). •Solid functional working knowledge of 21 CFR Parts 210 and 211 and FDA OTC monograph requirements. •Demonstrated experience with batch record review and product disposition/release decisions. •Hands-on experience managing deviation, CAPA, OOS/OOT, complaint, and change control systems. •In-depth knowledge of supplier quality management, including supplier qualification and incoming material inspection programs. •Excellent written and verbal communication skills, including technical writing for SOPs, investigation reports, and regulatory correspondence. •Proficiency with quality management software/eQMS platforms (e.g., MasterControl, TrackWise, Veeva QMS, ETQ) and standard office software. •ASQ certification (Certified Quality Manager/Organizational Excellence, Certified Quality Engineer, or Certified Quality Auditor) or equivalent. •Operational familiarity with combination products or Class I/II medical device requirements (21 CFR 820). Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!