QA Specialist III

    Job Description This position is primarily responsible for administering Quality Assurance support for SPG Operations and control of Quality Records, especially as it pertains to the Manufacturing, QA, QC and Product Development/Process Improvement.  Will be responsible for a wide range of functional needs, which involves close interaction with the staff involving the development and maintenance of documentation and programs.  As an integral part of the Quality Systems team, participation in various quality related issues are required.  This position is also responsible for other duties as assigned including:
Issue and audit manufacturing production record documents. 
Track lot numbers, audits and releases, completed batch records including release in MRP system and files completed records. 
Maintain Device History and various Quality Records. 
Maintain electronic files, indexes and databases to support documentation systems. 
Maintain electronic databases for variances, corrective actions, investigations, audits, management input, and other areas.
Provide suggestions on improvements in the documentation area. 
Provide backup to Document Control. 

 

Knowledge & Skills

Must possess excellent verbal and written communication skills, ability to work independently and able to prioritize numerous duties.  Working knowledge of FDA Regulations and ISO Standards, especially 13485:2003. Prefer experience in the numerous aspects of Operations.

 

Requires a high sense of urgency, initiative and common sense.  Must be pleasant, professional, and able to get along well with others, energetic, efficient and detail oriented. Must be highly skilled in computer systems and software and must be proficient with standard office equipment.

 

Education and Experience:

This position requires a Bachelors Degree in the Sciences, with a minimum of 5 years of experience in documentation, quality systems technical writing or equivalent.