Sr. Engineer QA - Manufacturing

 Requisition ID:                       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 an Engineer Sr – 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 with have a Bachelor’s degree in Engineering and 5+ years experience  with continuous improvement manufacturing processes in a highly regulated industry. This position requires leadership skills, the willingness and 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™.

 

Essential Duties and Responsibilities:

• Participates in the development of medical devices and components from design initiation through design transfer and by representing Quality Assurance for manufacturability in all design and development project teams.
• Participates in all manufacturing activities to assure compliance of design specifications.
• Leads development of quality plans of new product introductions based on designspecificatons, PFMEA, and control plans.
• Works with design team and assist/provide 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 apply 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 the project leader for key initiatives, identifies 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 assures the change management is controlled, adequate, and documented.
• Ensures information and documentation is 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 them with learning experience.
• Supports manufacturing suppliers with assistance in on-site resolution of quality and process related issues andcorrective and preventive actions.
• May supervise other engineers, technicians, and support personnel.

 

Education and Experience:

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

 

Knowledge and Skill Requirements/Specialized Courses and/or Training:

• 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, but not limited to GD&T, DOE, verification, and validation.
• SPC (Staticstical Process Control) knowledge.
• Strong communication skills and ability to communicate effectively with technical and non-technical staff.
• Project management skills