Quality Engineer

Summary:

WillowWood Global, a leading manufacturer of prosthetic devices, is looking for a Quality Engineer to join the Quality team at our manufacturing facility in Mt. Sterling, Ohio. The Quality Engineer is responsible for ensuring quality and regulatory requirements are met for all WillowWood products. The Quality Engineer will maintain Quality Management System records for ISO 13485:2016 and Medical Device Directive/Regulation, and FDA for Class I and Class II products and procedures.

Essential Responsibilities of the Job:

• Supports the mission, values and vision of WillowWood
• Have and maintain knowledge of current regulatory requirements and standards related to the development, required documentation, and release of medical devices, including ISO 13485, FDA, and Medical Device Regulation (MDR)
• Maintain a robust quality management system (QMS) that ensures compliance with all medical device regulations and safety standards across multiple sites for Class I and Class II mechanical, electronic, and software products
• Support long-term quality, regulatory and compliance policies for worldwide markets.
• Develop and support product development and design transfer activities by implementing standardized quality centric launch practices to enable business strategies.

• Support the maintenance of the associated product Technical Files

• Manage the review and approval of finished products manufactured for and by the company in accordance with their approved specifications
• Manage document control procedures
• Maintain and analyze quality performance data supporting QA Metrics tracking and performance improvement. Generate reporting for all stakeholders.
• Implement risk management procedures.
• Support for Test Method Validation, Verification and Verification strategies, activities, protocols and reports for products
• Manage restocking/refurbishing/disposal procedures for returned products.
• Analyze product rejects and returns. Identify opportunities for process improvement and development of best practice
• Create, evaluate, improve, and document processes for efficiency and effectiveness
• Monitor, maintain and manage calibration process
• Provide training of the Quality policies and procedures to members of the company and help establish a high level of continuous improvement philosophy
• Support post-market surveillance activities, including data collection and analysis, investigations, complaints and product recall activities, policies , and procedures.
• Support internal and external Audits for the organization, ensuring proper compliance within the QMS and regulatory agencies. Address post-audit action items, ensuring effective resolution.

Essential Qualifications and Skills Needed for the Job:

• Highly motivated individual who is passionate about providing the world's best prosthetic devices
• Bachelor's Degree or Masters' in Engineering Discipline preferred
• At least 3 years relevant occupation experience, preferably ISO 13485 and FDA regulated Medical Device industry with design and manufacturing of medical device products
• Ability to communicate, interact and influence effectively across internal functions and with outside partners and regulatory bodies.
• ASQ certification as Certified Quality Engineer , auditor or demonstrated advanced lean manufacturing skills and experience preferred

• Strong analytical and problem solving skills
• Strong computer and document management skills, including SolidWorks, eQMS, and PDM
• High level of attention to detail and accuracy and organization

• Travel required up to 15%

Quality Technical Expertise/Experience

• ISO 13485, FDA, and MDR requirements
• Global regulatory experience (EU, UK, Switzerland, Canada, Brazil, Colombia, Australia, New Zealand, China, India), MDSAP experience preferred
• Root Cause Analysis
• Risk management, FMEA
• Validation in medical device manufacturing
• Documentation Systems, including electronic Quality Management System software
• Audit (Internal, External, FDA)
• Device Master Records
• Change control
• Complaint Management
• Supplier performance management
• Receiving, Incoming inspection, Preservation of Product
• Traceability, Device History Records
• Non-conformance
• CAPA
• Training compliance
• Labelling and IFU (including virtual IFU) management
• UDI, GUDID, EURAMED
• Equipment validation, IQ/OQ/PQ
• Calibrations
• Preventive maintenance
• Work environment, Contamination control, Pest control
• Environmental Regulations, incl. WEEE, RoHS, REACH, etc

Equal Opportunity Employer