Posted on Monday, March 03, 2008
Quality Assurance Specialist (Medical Device)

Rapidly growing ISO 13485:2003 Certified Medical Device developer and manufacturer in St. Louis, Missouri is seeking a Quality Assurance Specialist with experience in multi-discipline device design and improvement. We are looking for an aggressive and experienced person to fill a new critical role in the organization. The candidate will be responsible for developing and implementing a compliant quality management system in a fast paced, team environment. The successful candidate must have experience in Quality Management Systems for the Medical Device industry, product inspection and testing, training and support for the organization in compliance matters.

Duties and Responsibilities

• Developing, implementing and improving overall quality systems, including quality standards, test methods, process control techniques, and reviewing documents such as Work Instructions, Quality Assurance Specifications, Final Inspection Instructions, protocols and reports to ensure safety, reliability and efficacy of products, processes and significant changes related to existing medical devices.


• Evaluate design quality, monitoring, qualification, validation and trouble shooting activities. This will encompass:
  
  1. product configuration control to assess the effects on materials compatibility, manufacturing processing and product physical properties;
     
  2. change control, validation and verification;
     
  3. defect corrective action process (investigation of performance issues on existing products)
     


• Perform inspection and testing on incoming, in process and finished products. Maintain the Complaint system, files, database, etc. Complaint processing may require customer contact regarding complaint information and resolution. Responsible for the document control function, updating databases, maintaining controlled copies, etc.


• This position will be responsible for tracking and preparing reports on Quality System metrics.
  

Education and/or Experience

• Two year college degree or equivalent education and experience and a minimum of 5 years related experience in Quality Assurance/regulatory affairs in the Medical Device industry.


• A complete and thorough understanding of the FDA QSR Regulations (21 CFR Parts 820), ISO 13485:2003 and ISO 14971 is required.


• Working knowledge of SPC, DOE, Probability and Statistics, Metrology or inspection methods and equipment, quality information systems and product inspection, testing and release experience.


• Experience with sterile products is a plus.
  

Certificates, Licenses, Registrations

ASQ CQE (Certified Quality Engineer) or CQA (Certified Quality Auditor) preferred

The strength of any company and its products is dependent upon the creativity, quality, and caliber of its employees. Envisioneering Medical Technologies offers exciting opportunities in the growing medical device industry.

To apply, visit monster.com and search for Envisioneering.

# posted by ASQ St. Louis @ Monday, March 03, 2008