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Engineer I, Quality Auditing - Fairfield, NJ

Company: Getinge Group
Location: Fairfield
Posted on: November 11, 2019

Job Description:

Job Functions:

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.

* 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.

* Must have ISO 13485:2106 Lead Auditor Certification.

Minimum Requirements:

* Bachelor's degree in engineering or related science (or equivalent), with 1 to 2 years of experience as a lead auditor ISO 13485:2016.

* 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.

#LI-DV1

#CBD#

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.

Keywords: Getinge Group, New York , Engineer I, Quality Auditing - Fairfield, NJ, Other , Fairfield, New York

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