Engineer I, Quality Auditing - Fairfield, NJ - Fairfield, NJ - Getinge

Date de Publication 10/7/2019

Résumé de l'offre

  • Type d'employé :
    Employé à plein temps
  • Expérience :
    Not Specified
  • Date de Publication
    10/7/2019

Description de l'offre

Job Functions: (Primary “essential” duties and responsibilities)

Fairfield and Mahwah facilities:

  • Plans, executes and reports on internal audits of facility quality systems.
  • Issues to management timely written audit reports and follows up on audit activities to ensure appropriate corrective action.
  • Supports Quality management, which includes ensuring that corrective and preventive actions are issued as required, properly investigated, documented, effective, and completed on time, and that audits are properly performed, documented, and completed in accordance with the annual audit procedure/schedule.
  • Facilitates and consults with corrective action teams in implementing changes to ensure compliance with all applicable ISO/QSR/MDD requirements.
  • Escalates audit findings to the appropriate level of management.
  • Assists the Director and Manager of Quality Assurance during third party audits.
  • Performs re-audits and/or effectiveness checks as a way of assessing and documenting CAPA Effectiveness
  • Identifies new opportunities for improvements to work processes.
  • This is not an inclusive list of job responsibilities.

Required Knowledge, Skills and Abilities:

  • Strong analytical and statistical skills
  • Ability to use Microsoft Office Products such as Word and Excel or equivalent software applications is preferred.
  • Project management and leadership experience is required.  Must demonstrate effective influencing and change management skills.
  • Must have verbal and written communication skills, and be effective and comfortable working in a cross-functional team environment.

Minimum Requirements: 

  • Bachelor’s degree in engineering or related science (or equivalent), with 1 to 2 years of experience in quality assurance or quality engineering experience, preferably in the medical device field.
  • Knowledge of GMP`s, FDA requirements, and ISO 13485 series standards.

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.

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Getinge Group is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.