Manager, Quality Assurance
Rockwell Medical, Inc.
June 27, 2026
On-site
Grapevine, TX
Operations
Job Summary:
The Quality Manager ensures site activities meet business objectives and regulatory compliance requirements. Provides leadership and oversight of the Quality Management System (QMS) and drives improvements related to products, processes, suppliers, quality systems, compliance, and customer satisfaction.
Responsibilities:
- Lead and maintain Quality System programs (CAPA, NCRs, complaints, internal/external audits, supplier qualification, record retention, change control, validation, calibration, training, document control).
- Coordinate review and release of raw materials and finished goods.
- Monitor QA/QC and Operations activities to ensure compliance with GMP, company, and regulatory requirements.
- Analyze quality metrics to identify trends, drive continuous improvement, and support business objectives.
- Lead investigations, root cause analyses, and corrective and preventive actions.
- Partner cross-functionally to improve product quality, process performance, supplier quality, and customer satisfaction.
- Lead, coach, and develop employees; foster a culture of quality, accountability, teamwork, and continuous improvement.
- Communicate quality risks and compliance concerns to senior management.
- Serve as primary contact for FDA inspections, State inspections, Notified Body audits, customer audits, and regulatory assessments.
- Ensure compliance with company policies/procedures and applicable regulatory requirements.
Qualifications:
- Bachelor’s degree (Engineering/Biological Sciences/Chemical Sciences or related) with 5–10 years medical device/pharma experience preferred; or Associate degree with 8–10 years relevant experience.
- Minimum 5 years Quality Assurance experience in FDA-regulated manufacturing.
- Strong knowledge of FDA regulations, cGMPs, quality systems, QA/QC processes, and regulatory compliance.
- Leadership/supervisory experience preferred.
- Experience supporting FDA/State/Notified Body/customer audits strongly preferred.
- Risk assessment/risk management knowledge.
- Root cause analysis and continuous improvement skills.
- Strong organizational, analytical, problem-solving, decision-making, and communication skills.
- Flexible schedule (weekends/overtime) as needed.
- Certified Internal Auditor and/or Six Sigma preferred.
- Must pass pre-employment background and drug screening.
The Quality Manager ensures site activities meet business objectives and regulatory compliance requirements. Provides leadership and oversight of the Quality Management System (QMS) and drives improvements related to products, processes, suppliers, quality systems, compliance, and customer satisfaction.
Responsibilities:
- Lead and maintain Quality System programs (CAPA, NCRs, complaints, internal/external audits, supplier qualification, record retention, change control, validation, calibration, training, document control).
- Coordinate review and release of raw materials and finished goods.
- Monitor QA/QC and Operations activities to ensure compliance with GMP, company, and regulatory requirements.
- Analyze quality metrics to identify trends, drive continuous improvement, and support business objectives.
- Lead investigations, root cause analyses, and corrective and preventive actions.
- Partner cross-functionally to improve product quality, process performance, supplier quality, and customer satisfaction.
- Lead, coach, and develop employees; foster a culture of quality, accountability, teamwork, and continuous improvement.
- Communicate quality risks and compliance concerns to senior management.
- Serve as primary contact for FDA inspections, State inspections, Notified Body audits, customer audits, and regulatory assessments.
- Ensure compliance with company policies/procedures and applicable regulatory requirements.
Qualifications:
- Bachelor’s degree (Engineering/Biological Sciences/Chemical Sciences or related) with 5–10 years medical device/pharma experience preferred; or Associate degree with 8–10 years relevant experience.
- Minimum 5 years Quality Assurance experience in FDA-regulated manufacturing.
- Strong knowledge of FDA regulations, cGMPs, quality systems, QA/QC processes, and regulatory compliance.
- Leadership/supervisory experience preferred.
- Experience supporting FDA/State/Notified Body/customer audits strongly preferred.
- Risk assessment/risk management knowledge.
- Root cause analysis and continuous improvement skills.
- Strong organizational, analytical, problem-solving, decision-making, and communication skills.
- Flexible schedule (weekends/overtime) as needed.
- Certified Internal Auditor and/or Six Sigma preferred.
- Must pass pre-employment background and drug screening.