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Quality Assurance Engineer

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Location: Dallas, TX, United States
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Description

  

  

   

   

   

       Position Title:Quality Assurance engineer              

   

JOB DESCRIPTION: The Quality Assurance Engineer provides GMP, CAPA, and Quality Systems training and guidance for employees and CAPA teams.  Manages and participates in all Internal and External Audit programs as needed. He/she will assist in the development and maintenance of systems used to manage complaints. Works with Department Heads to ensure that the learning needs of staff in relation to complaint handling are identified and that appropriate training is provided. Acts as internal reviewer on Quality systems documentation, Specifications, OOS, NCRs, Deviations, and DCA and develops documentation that meets organizational standards. Monitors timely investigation and implementation of CAPAs and NCRs, their progress against established thresholds and goals. Ensures compliance to the CAPA Process within the designated functional area(s) through independent reviews of CAPAs, and CAPA investigations.  

   

Responsibilities:  

 Provide GMP, CAPA, and Quality Systems training and guidance for employees and CAPA teams by:   

-     developing and delivering education and training in relation to complaints management and customer care.   

-     Keep up to date with current issues regarding complaints and risks and ensure that managers are kept informed of developments and their implications, and   

-     Managing and participating in Quality systems activities such as GMP training for new and existing employees, GMP awareness program, and coordinating training Programs/activities as needed.  

   

Manage and participate in the Internal and External Audit programs by:  

-     conducting audits, writing audit reports, distribution of reports and associated non-conformances, follow-up on designated timelines.  

-     Acting as a team player completing other duties as requested by the Quality Manager or as needed to facilitate the goals of the organization.  

-     Assisting contract customers as required to perform quality support on projects and during audits.  

-     Supporting Business Unit and /or vendor third party audits.  

-     Acting as internal reviewer on Quality systems, specifications, OOS, NCRs, Deviations, and DCA.  

   

Assists in the development and maintenance of procedures and policies for complaints by:  

- Participating in the development of maintenance systems used to manage complaints.  

-Evaluating all complaint activities in terms of quality, scope, and methodology and making appropriate recommendations.   

-Working with the Department Heads to ensure that the learning needs of staff in relation to complaint   

handling are identified and that appropriate training is provided, and  

-     Performing investigation of complaints and drafting responses for leadership review.  

    

Acts as internal reviewer on Quality systems documentation, Specifications, OOS, NCRs, Deviations, and DCA and develops documentation that meets organizational standards by:   

-     Researching, outlining, writing, and editing new and existing content, working closely with various departments to understand project or operational requirements.  

-     Independently gather information from subject matter experts to develop, organize, and write procedure manuals, technical specifications, and process documentation.  

-     Assuring cGMP, ISO, FDA and Quality System compliance by revising quality documents such as: Quality Manual, Quality Systems Procedures and Quality Specification as required by internal standard operating procedures.  

   

Monitors timely investigation and implementation of CAPAs and NCRs, and their progress against established thresholds and goals by:   

-     Participating in key CAPA and Continuous Improvement Process project and reporting to senior management on CAPA and NCR progress as needed.   

-     Identifying CAPA and NCR resources, monitoring applicable resource requirements and escalate requirements to senior management as needed.  

-     Functions as the Quality Assurance representative for the review and approval of CAPAs, Deviations, NCRs, Validations, and Complaints.  

-     Maintaining positive relations between Quality Assurance and all other functional areas and referring extraordinary situations to the Quality Manager for guidance when necessary as appropriate.  

   

Ensures compliance to the CAPA Process within the designated functional area(s) through independent reviews of CAPAs, and CAPA investigation by:   

-  Monitoring existing processes through trending and identifies and implements process improvements.  

-   Tracking and reporting all CAPA, NCR, Deviations, OOS metrics as applicable.  

-   Monitoring and highlight risk factors to include production of an annual report on complaints, monitoring trends, response times, outcomes, and action arising from complaints.  

   

Qualifications:  

 Bachelor’s degree in related technical field and/or 6-8 year work related experience in Quality Compliance, Quality Control or quality systems.  

Proficient knowledge of 21 CFR Parts 820, 210, 211, ISO 13485, and Quality Systems Regulations.  

Excellent communication, both oral and written, and ability to work with employees at all levels of the organization.  

Ability to perform under pressure and demonstrate problem solving and trouble shooting skills.  

Lean/Six Sigma Green Belt certification is preferred.   

   

  

  

  
  
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