Manager, Quality - Additive Manufacturing

Ricoh 3D for Healthcare delivers patient-specific, 3D-printed anatomical models that help clinicians enhance surgical planning, improve precision, and support better patient outcomes. By combining advanced 3D printing technology with medical imaging, Ricoh provides customized solutions that bring greater clarity to complex cases. Their innovative approach streamlines workflows for healthcare providers while supporting more personalized, efficient, and effective care.

Why You Should Join Us

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 role can be located in either the Indianapolis, IN, or Parma (Cleveland), OH area, and will be an on-site role.

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 bodie,s with support from Director-level Quality & Regulatory personnel.

What You’ll Do

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 with 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 the 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. 

What You’ll Need

• 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 with advanced manufacturing technologies, including 3D printing, strongly preferred

• Possess strong leadership, strategic, analytical, and organizational skills.

• Advanced problem-solving skills needed to resolve complex and/or high-impact process and quality problems, often requiring collaboration with other departments, customers, or vendors. 

• Excellent verbal and written communication skills; ability to write/understand technical documentation.

• Strong interpersonal and leadership skills; ability to lead and influence peers

• Established project management skills

• Strong data analysis skills.

• Ability to develop a high-performance culture with clear expectations of performance. 

• Ability to evaluate workflows and develop improvement strategies.

• Recognizes trends by collecting, organizing, and analyzing statistical data, 

• Can effectively envision, develop, and implement new strategies to address complex business issues.

• Displays good judgment - makes sound, justifiable decisions and acts to solve problems.

Working Conditions, Mental, and Physical Demands

• Work is performed in multiple types of environments, including typical office and manufacturing.

• Requires regular communication with peer leadership, senior leadership, and customers.

• Work has stress due to the impact the incumbent's decisions have on the business results.

• Minor physical effort is required, which may involve long periods of standing, walking, or similar activities 

• Requires moderate dexterity - regular application of basic skills (calculator, keyboard, etc.)

• May require up to 20% of time on business travel

Perks of the Job

• Base Salary Range: $100,000 – $120,000

• Bonus: Up to 16% (performance-based, tied to company objectives)

• Benefits: Standard Ricoh USA package (details to be provided separately).