Quality Specialist

Requisition Number:  8115
Company: 
Location: 

Kraków, MA, PL, 30-701

This role is part of the Global Business Services group while on the position you will be responsible for performing a variety of quality assurance duties to ensure internal processes, products and services meet quality (regulatory, statutory) and technical requirements defined internally, daily executing quality activities that support management system activities, internal and supplier audits, operating experience and lessons learned data gathering and analysis, corrective action issue data gathering, analysis and resolution and supplier product oversight activities, as well as  support strategic and continuous improvement initiatives.

 

Duties: 

  • Participate or support audits/assessments to ensure compliance with applicable regulations, codes and standards. 
  • Support audit planning and preparation activities including gathering data from previous internal audits, corrective action system, self-assessments, other external audit/industry available reports, etc.; confirm/update contact information;
  • Work with audited organization to plan interview sessions; participate on audit team as requested.  
  • Perform cursory review of supplier certification packages to ensure comprehensive and legible quality assurance records have been submitted in accordance with purchase order, manufacturing, and quality specifications.
  • Assist in development and compilation of supplier qualification documents including but not limited to audit plans, pre-award surveys, reports and supporting checklists while ensuring compliance with applicable QA policies and procedures
  • Lead the procedure revision process including distribution of procedure change requests (PCRs) to process/document owners, review and disposition of PCRs, notify site procedure coordinators and local level 3 process owners of planned procedure revisions
  • Assist process owners with formatting Level 1 manuals & Level 2 procedures/work instructions/job aides as well as editing of documents for consistency in how content is presented, as needed.
  • Support communication of changes in Quality processes and documentation and develop training material to support changes.
  • Assist in the coordination of third-party inquiries and audits, including government regulatory agencies, customers, industry entities and registrars.  This effort includes activities such as document/data gathering, coordinating interview sessions, etc.

 

 

Requirements:

  • Fluent in speaking, comprehending and writing in English
  • Working knowledge and application of codes, standards, and regulations such as US NRC Regulations and European Standards
  • Apply critical thinking skills and analytical techniques to interpret standards, analyze information, provide trend data, identify deviation, concisely communicate identified deviations and suggest recommended solutions to quality issues to both internal/external parties. 
  • Problem-solving skills and ability to develop solutions to mitigate risk.
  • Ability to communicate technical requirements and regulatory compliance information across various language barriers.
  • Active listener and possess interviewing skills
  • Ability to gain cooperation and build relationships.
  • Ability to work independently or as part of a team with some direction.
  • Takes initiative to plan work and set priorities while using a questioning attitude to identify risks.
  • Good time management and organizational skills.
  • Takes accountability for decisions and actions.
  • Meets expectations of performing high quality, error-free work
  • Previous audit experience desired
  • Project management capability desired

 

Offer:

 

  • Stable employment in newly created SSC in Krakow
  • Attractive remuneration with bonuses
  • Benefit package
  • Hybrid model of work

Employment opportunities may require access to information which is subject to the export control regulations of the United States. Hiring decisions for such positions are required by law to be made in compliance with these regulations. Applicants for employment opportunities in other countries must be able to meet the comparable export control requirements of that country and of the United States.

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