Sr. Engineer QA - Manufacturing

Overview

Requisition : 63270 Title: Sr. Engineer QA - Manufacturing Division: Arthrex Manufacturing Inc (US02)
Location: Ave Maria, FL

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Sr. Engineer - QA for our manufacturing site in Ave Maria, FL. The Sr. Engineer - QA is responsible for various Quality Assurance functions for the manufacturing development of medical devices. The ideal candidate will have a Bachelor's degree in Engineering and 5+ years of experience with continuous improvement manufacturing processes in a highly regulated industry.

This position requires leadership skills, and the ability to mentor Quality Assurance team members.

Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better.

• Participates in the development of medical devices and components from design initiation through design transfer by representing Quality Assurance for manufacturability in all design and development project teams.
• Participates in all manufacturing activities to assure compliance with design specifications.
• Leads development of quality plans for new product introductions based on design specifications, PFMEA, and control plans.
• Works with design team and provides feedback on design specifications and improvements.
• Evaluates and develops effective and efficient methods of testing and inspection of products.
• Utilizes problem solving tools and techniques and applies a risk-based approach to problem solving.
• Determines necessity of testing and initiates testing by preparing test and inspection plans, and identifying and obtaining required test fixtures and test/inspection instrumentation.
• Initiates new projects and acts as project leader for key initiatives, identifying best practices.
• Provides technical support on manufacturing technical issues.
• Performs quality trending and leads/supports process improvement initiatives.
• Approves manufacturing product and process changes and ensures change management is controlled, adequate, and documented.
• Ensures information and documentation are consistently accurate.
• Responsible for MRB activities for assigned products, timely resolution of nonconformities, issuing and/or monitoring corrective actions associated with nonconformance and deviations.
• Provides input and direction to other members of the quality assurance department to assist them in their assignments and provide learning opportunities.
• Supports manufacturing suppliers with on-site resolution of quality and process-related issues and corrective and preventive actions.
• May supervise other engineers, technicians, and support personnel.

• Bachelor's degree in Engineering required
• 5 years of experience in a Quality Control or Quality Assurance position required, preferably in a medical device company.

• Working knowledge of risk assessments, design control requirements, PFMEAs, control plans, quality plans, testing and inspection equipment and techniques.
• Manufacturing process knowledge.
• Technical knowledge in development methodologies, design, project implementation, including GD&T, DOE, verification, and validation.
• SPC (Statistical Process Control) knowledge.
• Strong communication skills and ability to communicate effectively with technical and non-technical staff.
• Project management skills preferred.
• Recognized process improvement (e.g., Lean, Six Sigma) and problem solving (e.g., RCA, DMAIC, 5 Whys) training preferred.

Proficiency in the use of PC and programs, particularly Excel, Word (or equivalents), and QAD or similar inventory software.

Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret a wide range of technical instructions and work with abstract and concrete variables.

Mathematical

Skills:

Ability to apply mathematical principles as required by the job.

Language and Communication: Ability to communicate ideas and issues effectively to team members and management. Ability to write and record data and information as required by procedures.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit;

use hands and fingers to handle or feel; and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds.

• Visual acuity necessary to do the job safely and effectively.
• Specific vision abilities required by this job…