Maintain and continuously improve the company’s QMS in compliance with ISO 9001 and ISO 13485 standards.
Ensure that quality objectives are established, tracked, and met across departments.
Lead internal audits and manage external audits by customers, registrars, and regulatory agencies.
Oversee document control, CAPA, non-conformance, and risk management processes.
Ensure compliance with applicable regulatory requirements (e.g., FDA 21 CFR Part 820 for medical devices).
Manage regulatory inspections and certification audits.
Develop and enforce procedures and policies that support compliance.
Drive root cause analysis and implement effective corrective/preventive actions (CAPA).
Work closely with Engineering, Production, and Supply Chain to ensure product quality from design to shipment.
Manage incoming, in-process, and final inspection processes.
Lead initiatives to reduce scrap, rework, and returns.
Develop and maintain supplier quality performance metrics.
Conduct supplier audits and qualification.
Collaborate with suppliers to resolve quality issues and drive continuous improvement.
Lead and develop the Quality Team, including QA Engineers, Technicians, and Inspectors.
Foster a culture of quality, compliance, and continuous improvement across the organization.
Provide quality training to cross-functional teams.
Other job duties as assigned
Requirements
Bachelor's degree in Engineering, Quality, or related technical discipline (Master’s degree a plus).
Minimum 5–8 years of experience in quality management in a technology or electronics manufacturing environment, preferably with exposure to medical devices.
In-depth knowledge of ISO 9001 and ISO 13485 standards; ASQ certifications (e.g., CQE, CQM/OE) preferred.
Experience with FDA regulatory requirements and medical device compliance (21 CFR 820) is a strong plus.
Proficiency in root cause analysis tools (e.g., 5 Whys, Fishbone, FMEA, 8D).
Strong understanding of statistical process control (SPC) and data analysis.
Excellent project management, communication, and cross-functional collaboration skills.
Experience leading audits and representing the company during regulatory or customer inspections.
Excellent leadership, communication, and project management skills.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
ISO 9001ISO 13485CAPAroot cause analysis5 WhysFishboneFMEA8Dstatistical process controldata analysis
Soft skills
project managementcommunicationcross-functional collaborationleadershipcontinuous improvementquality training
