- Company Name
- Bis Henderson
- Job Title
- QA Manager
- Job Description
-
Job title: QA Manager
Role Summary: Lead and manage a high‑performing quality assurance team within a regulated manufacturing environment, ensuring compliance with applicable standards (e.g., ISO 9001, ISO 13485, GMP) and driving continuous improvement of quality systems and processes.
Expectations: Deliver robust quality management, maintain regulatory compliance, manage audit preparation, oversee investigation of nonconformities, and support cross‑functional teams to drive operational excellence.
Key Responsibilities:
- Oversee the quality management system, ensuring adherence to relevant standards and regulatory requirements.
- Lead internal and external audit activities, coordinating schedule, scope, and follow‑up on corrective actions.
- Manage investigations of nonconformities, root‑cause analysis, and implement preventive measures.
- Develop and implement quality metrics, KPIs, and dashboards to monitor performance and support data‑driven decision making.
- Coach, mentor, and evaluate QA team members, fostering professional development and skill growth.
- Collaborate with R&D, production, and supply chain to address quality risks and ensure product compliance prior to release.
- Maintain accurate and timely quality documentation, including SOPs, work instructions, and quality plans.
- Participate in cross‑functional projects focused on process improvement, Six Sigma initiatives, and new product introductions.
Required Skills:
- Leadership and team management.
- In‑depth knowledge of regulatory standards (ISO 9001, ISO 13485, GMP).
- Experience with internal and external audits, risk management, and CAPA processes.
- Strong analytical, problem‑solving, and root‑cause analysis skills.
- Excellent communication, presentation, and stakeholder‑management abilities.
- Proficiency with quality management software, data analysis tools, and MS Office suite.
Required Education & Certifications:
- Bachelor’s degree in Engineering, Life Sciences, or a related field.
- Certified ISO 9001 Lead Auditor or equivalent quality management certification preferred.
- Six Sigma Green Belt or higher advantageous.