Job Description

Key Responsibilities

• Quality Systems & Compliance
• Maintain and continuously improve Quality Systems in alignment with FDA 21 CFR Part 820 , ISO 13485 , and MDSAP requirements.
• Oversee quality planning, document control, internal audits, inspection procedures, change management, and CAPA processes.
• Risk Management & Process Validation
• Lead the development of PFMEAs , Control Plans , and other risk analysis tools for new and existing products.
• Plan and execute validation activities ( IQ/OQ/PQ ) for processes, equipment, and test methods in compliance with regulatory standards.
• Design Transfer & Production Support
• Review and approve Engineering Change Orders (ECOs) , Manufacturing Variances (MVs) , and process documentation.
• Support new product introduction (NPI) initiatives and major process changes with robust quality planning.
• Quality Monitoring & Continuous Improvement
• Analyze production and field return data to identify trends, root causes, and improvement opportunities.
• Participate in or lead Product Line Quality Committees (PLQCs) to drive process enhancements and product reliability.
• Generate reports on non-conformances, CAPAs, and other quality metrics; present findings to cross-functional teams.
• Problem Solving & CAPA Management
• Lead or support investigations and root cause analyses; drive effective corrective and preventive actions.
• Utilize statistical tools ( SPC , Minitab , etc.) to support data-driven decision making.

Qualifications

• Deep understanding of FDA 21 CFR Part 820 , ISO 13485 , and MDSAP requirements.
• Demonstrated experience in validation (IQ/OQ/PQ) , PFMEAs , risk analysis , and quality planning .
• Proficient in data analysis , SPC , and report generation using tools such as Minitab or similar.
• Skilled in inspection techniques, sampling plans, and quality control procedures.
• Strong interpersonal, communication, and cross-functional collaboration skills.
• Proficiency in Microsoft Office Suite (Word, Excel, Access); experience with Power BI , MasterControl , or other quality systems is a plus.
• Six Sigma Green Belt and internal auditing experience are highly desirable.

Education & Experience

• Bachelor’s degree in Engineering , Life Sciences , or a related technical field.
• Minimum of 6+ years of experience in Quality Engineering within a regulated medical device or IVD industry, or 2+ years at a senior level.

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