Overview
Senior Quality Engineer Jobs in Minneapolis, Minnesota, USA at Lumicity
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Recruitment Consultant at Lumicity | Life Sciences | Senior and Executive Positions
Essential Functions:
Lead quality problem-solving and root cause analysis to prevent issues in manufacturing.
Investigate technical issues, testing status, and implement CAPA procedures for product quality and regulatory compliance.
Conduct supplier audits and inspections to verify system and product quality.
Represent the quality team in key meetings and work independently to resolve major issues.
Coordinate teams to address Out of Specifications, Deviations, CAPAs, and Change Controls.
Identify and resolve quality problems in production, QC, and analytical testing, evaluating the effectiveness of corrective actions.
Develop key quality metrics and analyze quality data for continuous improvement.
Update SOPs, conduct audits, and promote quality awareness across the organization.
Ensure compliance with company policies, cGMP, safety, and environmental regulations.
Participate in required safety and GMP training.
Strong knowledge of quality assurance methods and manufacturing processes.
Experience with quality management software (CAPA, FMEA, SPC).
Excellent analytical, critical thinking, and problem-solving skills.
Required Education & Experience:
Bachelor’s degree in Engineering (Master’s preferred).
3+ years of experience in pharmaceuticals.
Strong knowledge of quality systems (ISO 9001, GMP, FDA regulations) and industry standards.
ASQ Certified Quality Engineer (CQE) certification is a plus.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Pharmaceutical Manufacturing and Biotechnology Research
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Title: Senior Quality Engineer
Company: Lumicity
Location: Minneapolis, Minnesota, USA
Category: Quality Assurance – QA/QC, Engineering
