Manager, Quality Assurance

About Us

Rockwell Medical (Nasdaq: RMTI) is a healthcare company that develops, manufactures, commercializes, and distributes a portfolio of hemodialysis products to dialysis providers worldwide. Our mission is to provide dialysis clinics and the patients they serve with the highest quality products supported by the best customer service in the industry. We are focused on innovative, long-term growth strategies that enhance our products, our processes, and our people, enabling us to deliver exceptional value to the healthcare system and provide a positive impact on the lives of hemodialysis patients. Our products are vital to vulnerable patients with end-stage kidney disease, and we are relentless in providing unmatched reliability and customer service.

Joining the Team

Thank you for considering this opportunity to join our team. At Rockwell Medical, we work to foster an innovative, collaborative, and inclusive culture where everyone feels valued and empowered to succeed. We foster fresh ideas and encourage our team members to think outside the box. We are committed to professional development and offer opportunities at every level to make a real difference. Our employees positively impact our company, our customers, and the patients they serve. We understand the importance of maintaining a healthy work-life balance. While we are passionate about what we do, we equally value your well-being to ensure you have the opportunity to enjoy what matters most outside of work. In addition to offering competitive pay, we provide a comprehensive benefits package that includes health and dental insurance, retirement plans and other offerings to support your financial wellness and overall health.

Job Summary

The Quality Manager is responsible for ensuring all site activities meet business objectives and regulatory compliance requirements. This role provides leadership and oversight of the Quality Management System (QMS) and is accountable for identifying, analyzing, developing, and implementing improvements related to products, processes, suppliers, quality systems, compliance, and customer satisfaction.

The successful candidate will possess strong knowledge of regulatory requirements for medical device manufacturing, including 21 CFR Part 820, ISO 13485, and current Good Manufacturing Practices (cGMPs). This position requires the ability to lead complex quality initiatives, analyze quality metrics, drive continuous improvement efforts, and ensure compliance across manufacturing, testing, warehousing, and distribution operations.

The Quality Manager serves as the primary contact for FDA inspections, State inspections, Notified Body audits, and customer audits and reports directly to the Vice President, Quality.

Principal Responsibilities

• Lead and maintain Quality System programs, including CAPA, Nonconformance Reports (NCRs), Complaints, Internal and External Audits, Supplier Qualification, Record Retention, Change Control, Validation, Calibration, Training, and Document Control.
• Coordinate the review and release of raw materials and finished goods.
• Monitor Quality Assurance (QA), Quality Control (QC), and Operations activities to ensure compliance with GMP, company, and regulatory requirements.
• Analyze quality metrics and performance indicators to identify trends, drive continuous improvement initiatives, and support business objectives.
• Lead investigations, root cause analyses, and corrective and preventive actions to address quality and compliance issues.
• Develop a thorough understanding of manufacturing and quality processes to ensure operational excellence and regulatory compliance.
• Partner with cross-functional teams to improve product quality, process performance, supplier quality, and customer satisfaction.
• Lead, coach, and develop employees while fostering a culture of quality, accountability, teamwork, and continuous improvement.
• Communicate quality risks, compliance concerns, and improvement opportunities to senior management.
• Serve as the primary contact during FDA inspections, State inspections, Notified Body audits, customer audits, and regulatory assessments.
• Ensure compliance with all company policies, procedures, and applicable regulatory requirements.
• Perform other duties as assigned.

Qualifications

• Bachelor's degree in Engineering, Biological Sciences, Chemical Sciences, or a related discipline with 5-10 years of medical device or pharmaceutical industry experience preferred; or an Associate degree with 8-10 years of relevant industry experience.
• Minimum of five (5) years of experience in Quality Assurance within a medical device, pharmaceutical, or other FDA-regulated manufacturing environment.
• Strong knowledge of FDA regulations, cGMP requirements, quality systems, QA/QC processes, and regulatory compliance standards.
• Previous leadership, supervisory, or management experience within an FDA-regulated industry preferred.
• Experience supporting FDA inspections, State inspections, Notified Body Audits,and customer audits strongly preferred.
• Working knowledge of risk assessment and risk management principles and tools.
• Demonstrated ability to apply root cause analysis methodologies and continuous improvement practices.
• Excellent organizational, analytical, problem-solving, and decision-making skills.
• Strong written, verbal, interpersonal, and leadership skills with the ability to communicate effectively at all organizational levels.
• Ability to work flexible schedules, including weekends and overtime, as business needs require.
• Certified Internal Auditor and/or Six Sigma certification preferred.
• Must be able to successfully pass pre-employment background and drug screening requirements.