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Position Overview
We are seeking a detail-oriented Quality Systems Engineer who will develop, implement, and maintain the company’s Quality Management System (QMS) to join our team. This role is responsible for ensuring compliance, process efficiency, and continuous improvement across the organization. This role collaborates closely with Manufacturing, Engineering, Supply Chain, and Compliance teams to strengthen quality processes, support audits, and drive data-informed improvements.
Responsibilities
Develop, implement, and maintain QMS documentation, including policies, procedures, work instructions, forms, and manuals in compliance with FDA, ISO, and GMP requirements.
Monitor and analyze quality metrics to identify trends, risks, and opportunities for improvement.
Lead and support internal audits, ensuring QMS compliance and readiness for external audits or inspections.
Serve as a primary quality representative for external audits and inspections.
Support CAPA, deviations, complaints, and nonconformance investigations, including root cause analysis and corrective action implementation.
Develop and deliver QMS training programs to ensure all employees understand regulatory and company quality requirements.
Collaborate with cross-functional teams on continuous improvement initiatives leveraging QMS and digital tools.
Evaluate, select, and implement eQMS or digital quality tools to enhance system performance and compliance.
Maintain accurate and timely documentation and record-keeping in accordance with regulatory requirements.
Assist with management review reporting, including dashboards and KPIs to support leadership decisions.
Qualifications & Skills
5+ years of experience in regulated manufacturing, quality systems engineering, or quality assurance (medical device, pharmaceutical, biotech, or food).
Strong knowledge of FDA, ISO, and GMP standards; ISO 13485 or FDA 21 CFR Part 820 experience.
Experience with QMS development, implementation, and maintenance, including audits and process improvement.
Proficiency in MS Office and familiarity with eQMS platforms (Veeva, TrackWise, SmartSolve, SAP QM).
Strong analytical, problem-solving, and organizational skills.
Excellent verbal and written communication skills.
IT/digital technology experience to support system optimization.
Lean Six Sigma or continuous improvement certification.
Experience in medical device, pharmaceutical, or biotech manufacturing.
Work Environment
Climate-controlled manufacturing facility with exposure to aromas and chemical substances (PPE provided).
Fast-paced, deadline-driven production environment.
Fast-paced, collaborative, and growth-oriented environment where continuous improvement and innovation are valued.
May require overtime or weekend work during peak production schedules.
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Responsibilities
Develop, implement, and maintain QMS documentation, including policies, procedures, work instructions, forms, and manuals in compliance with FDA, ISO, and GMP requirements.
Monitor and analyze quality metrics to identify trends, risks, and opportunities for improvement.
Lead and support internal audits, ensuring QMS compliance and readiness for external audits or inspections.
Serve as a primary quality representative for external audits and inspections.
Support CAPA, deviations, complaints, and nonconformance investigations, including root cause analysis and corrective action implementation.
Develop and deliver QMS training programs to ensure all employees understand regulatory and company quality requirements.
Collaborate with cross-functional teams on continuous improvement initiatives leveraging QMS and digital tools.
Evaluate, select, and implement eQMS or digital quality tools to enhance system performance and compliance.
Maintain accurate and timely documentation and record-keeping in accordance with regulatory requirements.
Assist with management review reporting, including dashboards and KPIs to support leadership decisions.
Qualifications & Skills
5+ years of experience in regulated manufacturing, quality systems engineering, or quality assurance (medical device, pharmaceutical, biotech, or food).
Strong knowledge of FDA, ISO, and GMP standards; ISO 13485 or FDA 21 CFR Part 820 experience.
Experience with QMS development, implementation, and maintenance, including audits and process improvement.
Proficiency in MS Office and familiarity with eQMS platforms (Veeva, TrackWise, SmartSolve, SAP QM).
Strong analytical, problem-solving, and organizational skills.
Excellent verbal and written communication skills.
IT/digital technology experience to support system optimization.
Lean Six Sigma or continuous improvement certification.
Experience in medical device, pharmaceutical, or biotech manufacturing.
Work Environment
Climate-controlled manufacturing facility with exposure to aromas and chemical substances (PPE provided).
Fast-paced, deadline-driven production environment.
Fast-paced, collaborative, and growth-oriented environment where continuous improvement and innovation are valued.
May require overtime or weekend work during peak production schedules.
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