Quality Assurance Analyst, Sr. - Healthcare jobs in Sumter, SC

For certain roles at at this client, assignment is contingent upon the Employer of Record’s receipt of sufficient proof that you are fully vaccinated against COVID-19 (meaning two weeks have passed after the last injection of Pfizer/Moderna or two weeks after receipt of the J&J). In some locations, testing for COVID-19 may be available and/or required. Requests for accommodation will be considered pursuant to applicable law.

Shift: 1st Shift

JOB SUMMARY (Briefly describe the job’s primary purpose or contribution to the department or organization)
Performs statistical analysis of new and existing processes through the use of design of multi-vari, factorial and performance experiments/testing; identifying root cause of product defects and process waste and recommending to management appropriate corrective action(s). Evaluates all changes, modifications and additions to product lines and determines the effect on product quality and costs. Coordinates the total Quality Awareness Program within his/her business segment, informing all inspection and management personnel of quality problems and solutions. Reports directly to a Quality Manager..

ESSENTIAL FUNCTIONS
Through the use of accepted statistical engineering principles and experimentation design, initiates capability studies of processes to identify causes of chronic levels of defects and remedy those areas associated with a high cost of quality.
Provides functional support to the Engineering Department for the writing of protocols, data gathering and data analysis associated with the Plant Validation Program – including prospective, retrospective and revalidation efforts. Conduct process capability studies and/or process optimization studies prior to validations.
Acquires data from critical processes allowing for trend analysis and recommends action to be taken to maintain/obtain statistical process control.
To assure coordination of the overall quality effort within the plant in the following areas:

• Provides plant self-audit information on the product and process to assure compliance with all government regulations (QSR, FDA and Contractual).
• Periodically reviews Quality specifications to assure accuracy and adequacy.
• Formulates and implements policies and procedure relating to product quality or process control as appropriate.
• Provide test and statistical support to customer complaint issues that arise and make recommendations on actions to be taken.
• Conducts vendor (equipment and/or raw material) quality evaluations at vendor sites as required.

ADDITIONAL RESPONSIBILITIES
Operates within the Safety and QSR guidelines of Client.
Performs miscellaneous duties as required by management. BD04123JD