Quality Manager– Medical Device Manufacturing

MANAGER I, QUALITY, ADDITIVE MANUFACTURING

 

POSITION PROFILE

The Manager of Quality will hold a role overseeing quality responsibilities and documentation for the Ricoh 3D Printing for Healthcare covering production related quality activity for multiple sites.

This position provides leadership and assures the quality of materials, products, systems, and processes in compliance with 21 CFR 820, ISO 13485, and other applicable regulations. The Manager of Quality will also represent the established quality systems with external agencies such registrar/notified bodies with support from Director level Quality & Regulatory personnel.

 

Job Duties and Responsibilities

Quality System Development and Management

• Manages and continuously improves the organization’s quality systems, including  Document Control, Training, Internal Auditing, Management Review, CAPA and NC.
• Executes strategies related to quality assurance and quality control of products, services, and manufacturing processes; enacts preventive and corrective actions to assure product compliance to specifications.
• Drives tactical and strategic quality improvement plans, and all quality related activities and initiatives.
• Ensures that products and services perform according to quality standards, and that manufacturing processes are capable and qualified.
• Utilizes methods such as Lean, Six Sigma, and risk management tools to monitor and drive process improvement activities.
• Works collaboratively with manufacturing and biomedical leadership to establish quality systems and processes within production workflows from job receipt through shipping & billing.
• Works cooperatively with the production team to identify systemic quality issues within the plant and develop robust corrective actions.
• Collaborates with other functional areas to resolve product quality claims; administers the returned merchandise process and/or product rework activities; directs cross-functional projects to investigate and resolve major or pervasive product quality problems.
• Recommends and may approve the suspension or release of product for shipment to customers. 
• Directs the development, improvement and maintenance of electronic quality management system to ensure quality policies and processes are supported and documented.
• Directs projects to establish new standards and inspection procedures for new product launch.
• Continually seeks to advance Ricoh’s AM quality systems and standards; ensures the timely execution of quality simplification and improvement concepts to meet evolving needs 
• Develops, recommends and implements quality assurance and quality control department short-term and long-term plans, budgets and targets to support business objectives. 

Inspection, Auditing and Reporting

• Plans and manages internal quality system and process evaluations.
• Directs activities to determine quality testing and inspection equipment requirements, and to acquire and maintain the equipment necessary to validate product quality.
• Ensures compliance with FDA, HIPAA, and other applicable regulations.
• Develops, recommends, and implements policies, processes and systems to achieve quality goals for multiple product lines in compliance with applicable regulations.   
• Coordinates external audits with responsible agencies. Prepares or reviews reports on compliance issues and areas for corrective/preventive action. 
• Frequently communicates with peers, leadership, customers, regulatory agencies, auditors, and suppliers to resolve issues with product quality or assess the efficacy of quality systems and processes. 
• Prepares or manages the preparation of periodic reports summarizing quality trends and problems; presents information to operations management.

Personnel Management and Training

• Recruits, assists with selection, and develops the AM Quality team
• Directly manages Quality staff members and oversees all quality activities
• Leads and participates in projects or on teams to analyze product and material quality issues, identify root cause and make recommendations to resolve product problems. 

QUALIFICATIONS (Education, Experience, and Certifications)

• Bachelor’s degree in a technical field and 3+ years of experience in manufacturing quality operations medical device industry. 
• ISO 13485 experience required
• Experience working under 21 CFR 820 required
• Prior experience with medical qualification and validation protocols for equipment, systems, processes and products strongly preferred

Prior experience in with advance manufacturing technologies, including 3D printing, s