Job Description

POSITION SUMMARY

The incumbent in this position is responsible, under the VP level supervision, for leading, supporting and ensuring the continued suitability of the Quality Management System (QMS), conducing risk assessments, supporting product development and manufacturing processes; and nonconformance, complaint, and CAPA investigations. This position will also support other areas of the Regulatory Affairs and Quality Assurance department and additional tasks determined by management.

ESSENTIAL DUTIES & RESPONSIBILITIES

• Assist in the development and improvement of corporate policies and procedures relating to all aspects of the QMS, ensuring compliance with FDA, ISO 13485, and other applicable regulations.
• Participate in product lifecycle activities ensuring compliance with design controls and risk management principles (design and development, verification and validation, design transfer and release, and post-market surveillance).
• Collaborate with engineering, manufacturing, and regulatory teams to ensure adherence to quality standards throughout development and production utilizing a risk-based approach.
• Coordinate and lead risk management activities such as risk assessments and pFMEA to identify hazards and risk control measures that ensure patient safety and product quality.
• Oversee/lead root cause analyses, non-conformance investigations, product complaints, and CAPA-related activities.
• Generate annual audit plan; coordinate, conduct and support internal and external audits, including supplier audits, ensuring compliance with quality and regulatory standards.
• Support Regulatory Affairs functional area as needed (Regulatory submissions, Safety testing, etc.)
• Provide guidance to management on tools, techniques and systems for quality assurance, compliance, and continuous quality improvement.
• Compile and report quality metrics for post-market surveillance and Management Review meetings.
• Assist in training company employees on quality principles; mentor and train junior QA personnel on best practices, standards, and regulatory requirements.
• Support CSV/CQV activities for various electronic systems and test equipment.
• Review Change Management requests to ensure quality and regulatory requirements are included and met.
• Support Document Control and Training Records management.
• Stay current on industry trends, emerging regulations, and best practices to guide continuous improvement initiatives.
• Complete special projects as assigned.

EDUCATION, EXPERIENCE & SKILL REQUIREMENTS

• BS/BA in science or technical field and at least 5 years’ Quality Assurance experience in the medical device industry.
• Must have a complete understanding of medical device industry regulations (ISO 13485, FDA QMSR, ISO 14971).
• Strong quality background in analysis, problem solving, risk-based decisions, and statistical techniques.
• Effective time management, planning and organizational skills, with the ability to multi-task in a fast-paced environment.
• Previous auditing experience and participation in regulatory audits/FDA inspections.
• Experience with Document Control/Change Management processes.
• Excellent interpersonal and communication skills required to work effectively with all levels of staff.
• Ability to clearly present written information and findings at an executive level.
• Detail oriented, thorough, and observant.
• Must be a self-starter and team player able to work with minimum supervision among all levels in the organization.
• Computer proficiency required in Excel, PowerPoint, Word.

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