Responsible for leading the Quality Assurance organization to ensure compliance with applicable regulatory requirements, quality standards, and customer expectations.
This role provides strategic and operational leadership for the Quality Management System (QMS), oversees product quality throughout the manufacturing lifecycle, and drives a culture of quality, compliance, and continuous improvement.
Key Responsibilities
Quality Management System
Ensure the effectiveness and continual improvement of the Quality Management System (QMS).
Maintain compliance with FDA, ISO *****, MDR (where applicable), and customer requirements.
Lead internal and external audits and regulatory inspections.
Monitor quality metrics and drive improvements through data analysis.
Product Quality Assurance
Oversee incoming, in-process, final inspection, and product release activities.
Ensure effective management of nonconforming products, investigations, deviations, and CAPAs.
Review and approve quality documentation, including procedures, validation documentation, and engineering changes.
Operations Support
Partner with Manufacturing and Engineering to improve process capability and product quality.
Support New Product Introduction (NPI), process validations (IQ/OQ/PQ), and manufacturing transfers.
Ensure effective implementation of risk-based quality controls.
Regulatory & Customer Compliance
Act as primary quality representative during customer audits and regulatory inspections.




Support customer complaint investigations and field actions when required.
Ensure compliance with Quality Agreements and customer-specific quality requirements.
Support supplier qualification, monitoring, and supplier corrective actions.
Collaborate with Supplier Quality on material-related investigations and risk assessments.
Leadership & Talent Development
Lead, coach, and develop Quality Engineers, Supervisors, Inspectors, and Technicians.
Establish performance objectives and competency development plans.
Promote accountability, teamwork, and a Quality-First culture.
Drive Lean, Six Sigma, and risk-based quality improvement initiatives.
Develop KPIs and dashboards to monitor organizational performance.
Lead strategic projects focused on reducing defects, improving yields, and enhancing customer satisfaction
Qualifications
Education
Bachelor's degree in Engineering, Life Sciences, or related technical discipline.
Master's degree preferred.
Experience
7-10+ years of progressive experience in Quality within the medical device industry.
3-5+ years of leadership experience managing Quality teams.
Experience supporting FDA inspections and ISO ***** certification audits.
Strong knowledge of manufacturing processes, process validation, and risk management.
Technical Knowledge
FDA 21 CFR Part 820 (QMSR)
ISO *****
ISO *****
CAPA, NCMR, SCAR
Validation (IQ/OQ/PQ)
SPC and statistical analysis
Root cause analysis methodologies
Internal and supplier auditing
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