Specialist,Quality Assurance

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Quality
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191C3 Requisition #
JOB SUMMARY:

Administers and maintains Midmark Corporations’ regulated Document Control, and Customer feedback processes, manual and electronic, in accordance with FDA and ISO regulation by performing the following duties.

 

ESSSENTIAL/PRIMARY DUTIES:

  • Coordinate the Engineering Change Orders (ECO) process, ensuring update, prompt release, and distribution of related documents and files to applicable personnel. Ensure that all “OBSOLETE” documents are retrieved/collected, archive and or purged/disposed of accordingly.        
  • Generate and maintain all document numbers and their related revisions as per the ECO process. Ensure that all documents and or part numbers are issued according to the prescribed part numbering and or document numbering schemes. Key; review all relevant QP as numbers are issued to ensure compliance
  • Maintain all controlled master documents, including hard copy documents and software
  • Ensure that all updates to Master List of Documents are made promptly and accurately
  • Ensure that Controlled Document Logs are created for all controlled records; QP, WI, travelers, manufacturing procedures, quality forms, etc. Ensure updates are done promptly and accurately
  • Quality Record Management forms must be created for all quality records; maintain Quality Records Management forms in binder; update promptly and accurately
  • Assist with various departments to create and maintain travelers, work instructions, quality forms, logs, test reports/test results and other misc. documents related to the quality management system
  • Process changes/updates to the NPD templates in accordance with ECO procedures; reference NPD WI
  • Maintain controlled document binders and or electronic folders for Engineering, Manufacturing and Technical Services
  • Assign lot numbers to manufacturing and or vendors and maintain the Lot Number Assignment Log up to date. Assist in trending failures for lot controlled products
  • Assist Quality System Manager in gathering raw data for failure analysis/trending. Ensure updates to dashboard are done in a timely manner (monthly)
  • Assist Quality System Manager with internal and supplier audits of the quality management systems. FDA, ISO, and other regulatory audits
  • Identify and implement document control process improvements to streamline processes in document control or to adjust to changes in quality and regulatory requirements.
  • Review complaints for required information and clarity.
  • Maintain Customer Complaint Log.
  • Recognize if complaints meet requirements for mandatory/voluntary reporting to notified bodies.
  • Determine if complaint has previously been addressed according to relevant complaint & CAPA history.
  • Coordinate assignment of complaint evaluation with appropriate personnel.
  • Ensure timely follow-up of complaint for status and completion.
  • Organize complaint closure.  All supporting documentation is completed and filed with complaint. Communication of complaint closure with effected departments.
  • Maintain complaint records, including hard copy of documentation and electronic files.
  • Analyze complaint data and trend for presentation & discussion.
  • Identify and implement complaint process improvements streamline processes in quality or to adjust to changes in quality and regulatory requirements.
  • Support or lead CAPAs and the CAPA process. This includes development of CAPA Review Board
 
 

SECONDARY DUTIES:

  • Support quality initiatives around risk analysis and risk management
  • Develop inspection plan and lead test method qualification studies
  • Support training database maintenance and development.  Run training reports for presentation & discussion.
  • Review service records, identify potential customer complaints
  • Review quality data, identify trends and prepare charts 

EDUCATION and/or EXPERIENCE:

This position requires an Associate’s degree (A.A.) from a two-year college or university; or two years’ related experience and or training; or equivalent combination of education and experience. Successfully completed ISO Internal Auditor training.

 

Preferred: Familiarity with ISO 13485:2003 and 21 CFR Part 820 as they pertain to this position.

 

COMPETENCY/SKILL REQUIREMENTS:

 
  • Excellent organizational skills, a high attention to detail, and ability to multitask. 
  • Strong writing, grammar and proofreading abilities; can effectively present information in one-on-one and small groups and to other employees of the organization.
  • ISO Internal Auditor Training/Certification
 
 
SUPERVISORY RESPONSIBILITIES:

This job does not require supervisory responsibilities, there are no subordinate supervisors reporting to this job.


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