Manager, Quality Assurance

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.

Principal Responsibilities

• Lead and maintain Quality System programs, including CAPA, NCRs, Complaints, Internal and External Audits, Supplier Qualification, Record Retention, Change Control, Validation, Calibration, Training, and Document Control.
• Cook up 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.

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.
• Able to work flexible schedules, including weekends and overtime, as business needs require.
• Certified Internal Auditor and/or Six Sigma certification preferred.