Job Description
Your Role
- Own end-to-end quality management for the Associate Manager, Quality role within the Life Science division, ensuring compliance with ISO, GMP, and applicable regulatory standards.
- Lead cross-functional teams to embed quality practices throughout the product lifecycle and drive continuous improvement.
- Establish KPI-driven dashboards to monitor quality performance and progress toward strategic objectives.
- Maintain accountability for audit readiness, third-party certifications, and robust documentation practices.
- Collaborate with manufacturing and supply chain to conduct risk assessments and perform root cause analysis on customer complaints and non-conformances.
- Implement robust CAPA processes to prevent recurrence and drive corrective actions across functions.
- Coordinate Factory Acceptance Tests (FAT) with customers and ensure complete documentation packages for final product delivery.
- Promote a culture of safety, sustainability, and operational excellence while mentoring the team and aligning goals with the broader organizational mission.
- Lead end-to-end product quality releases and ensure products meet the organization’s quality standards
Who You Are
- You bring 8 or more years of experience in quality assurance or quality systems within regulated manufacturing environments, supported by a degree in Mechanical Engineering, Instrumentation Engineering, or related discipline.
- You have solid working knowledge of GMP and ISO standards, with hands-on experience managing quality management systems, document control workflows, and regulated deliverables across the product lifecycle.
- You hold a Lean Six Sigma Green Belt certification (Black Belt preferred) and have applied structured methodologies to drive measurable process improvements in manufacturing or packaging operations.
- You demonstrate proven capability in CAPA management, root cause analysis, non-conformance handling, and validation activities including IQ, OQ, and PQ with an understanding of CSV concepts.
- You have experience preparing for and managing external audits, inspections, and third-party certifications, as well as coordinating with customers during Factory Acceptance Tests.
- You are an effective communicator and cross-functional collaborator, with the ability to mentor and develop team members while aligning quality goals with broader organizational objectives.
- You bring a proactive approach to EHS compliance and sustainability, promoting a culture of safety, accountability, and continuous improvement within your team.