Teleflex, Inc. (NYSE: TFX), with $2.5 billion in revenues and operations in 27 countries, manufactures specialty engineered products for the medical, automotive, marine, industrial and aerospace industries.  With a core competency in OEM manufacturing, we are experts in the markets we service, partnering with our customers to deliver real-world solutions that are practical, cost-effective and reliable.

 

Teleflex Medical specializes in the design, manufacturing and distribution of high quality engineered surgical instruments, medical devices, and healthcare supplies for customers around the world. Teleflex Medical has extensive expertise in cardiovascular, plastic, orthopedic, spinal, urology, gynecology, ENT, and general surgery specialties.

 

The OEM group brings this expertise to our customers through two focused OEM entities. The OEM Specialties business is comprised of TFX Medical, the leading supplier of custom plastic extrusions, braid reinforced tubing, catheter and guide wire fabrication, and Deknatel, the leading supplier of custom sutures and medical fibers.  The OEM Orthopedics business is comprised of Beere and KMedic, the leading suppliers of orthopedic and spinal surgical instruments.  The OEM business is experiencing rapid growth and is seeking a high caliber individual to develop and implement a new discipline within the organization.

 

 

JOB SUMMARY

This position will provide technical support and take a leadership role in quality engineering functions in manufacturing and product development in compliance with FDA 21CFR Part 820, ISO 13485, and internal procedures.

 

 

PRIMARY RESPONSIBLITIES

• Direct quality activities in manufacturing such as inspection methods and Material Review Board (MRB).
  
• Support product development such as design change and review, quality planning, risk evaluation, and validation.
  
• Supervise Quality Assurance Inspectors if needed.
  
• Coordinate Corrective and Preventive Action (CAPA) for customer, internal, and vendor related needs.
  
• Audit internal and vendor processes and procedures.
  
• Participate in Continuous Improvement Projects (CIP) for both processes and business systems.
  
• Develop training programs for inspection and engineering.
  
• Represent company during customer or regulatory audits as needed.

 

POSITION REQUIREMENTS

Education

Must have a B.S. (technical degree preferred)

Work experience

Minimum 7-8 years QA engineering experience in a medical device manufacturing environment

ASQ certification highly desired

 

KNOWLEDGE / SKILLS

• Regulatory cGMP, QSR and ISO knowledge base
  
• Computer literate (MS Word, Excel, Access, PowerPoint, and Mini-tab preferred)
  
• Negotiation and problem solving skills
  
• Good oral and written communication skills
  
• Statistical Skills (DOE, SPC, Reliability, Gage R&R)
  
• Experience with risk analysis methodologies
  
• Experience in the area of manufacturing operations
  
• Ability to prioritize and work independently
  
• Validation concepts & techniques (process, equipment, and gauging)
  
• Experience developing training programs
  
• Able to work independently with limited supervision