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

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