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Quality Assurance Engineer, Corporate Audit - Merrimack, NH in Merrimack, NH at Getinge

Date Posted: 2/13/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Merrimack, NH
  • Experience:
    Not Specified
  • Date Posted:
    2/13/2019

Job Description

Together we can make a difference

At Getinge we are dedicated and passionate about helping our customers save lives and ensure excellent care. We provide innovations for operating rooms, intensive-care units, sterilization departments and for life science companies and institutions. Our portfolio combines well-known product brands such as Maquet, Pulsion, Atrium, Lancer and Datascope – just to name a few.

A career at Getinge will provide career opportunities that both inspire and challenge. Here, you can make a difference every day.

Job Function Summary:

The Quality Assurance Engineer – Corporate Audit is responsible for maintaining all corporate internal audit documentation and databases. They are responsible for interacting with applicable Getinge audited sites, as necessary, to assure that all audit functions meets the requirements of the internal audit program and applicable regulations. This individual acts as a compliance resource and provides recommendations for corrective action and tracks audit related corrective action commitments until closure.

Job Functions:

  • Ensures that internal audits are completed in compliance with regulatory requirements and documented procedures
  • Release the Corporate Internal Audit Schedule in the GetAligned System.
  • Notify Corporate Internal Auditors of Upcoming Audit Responsibilities as defined on the Getinge Corporate Internal Audit Schedule.
  • Track Corporate Internal Auditor Qualifications.
  • Supply Internal Auditors with applicable forms and documentation required to complete each audit.
  • Maintain Internal Audit Databases.
  • Reviews and monitors Internal Audit Reports and Finding sheets to ensure they are addressed and completed by the auditee in a compliant manor and within established timeframes.
  • Reviews and monitors identified internal audit non-conformances to ensure they are addressed and closed by the auditee in a compliant manor and within established timeframes.
  • Update and Maintain PowerPoint presentations for Management Review and Internal Audit Review Boards.
  • Updates audit procedures and associated documents to ensure ongoing compliance with national and international standards and regulations and compliance to corporate procedures.
  • Participates in completing Corporate Internal Audits, as necessary.
  • Duties may be modified or assigned at any time to meet the needs of the business

Required Knowledge, Skills and Abilities:

  • Excellent written and verbal communications skills.
  • Strong work ethic and attention to detail. 
  • Professional interpersonal skills necessary to interact with intercompany contacts.
  • Demonstrated time management and organizational skills; ability to work independently and as part of a team.
  • Working knowledge of medical device regulations, minimally ISO 13485:2016 and CFR 820
  • Evidence of training in international regulations (i.e. Korea, Japan, Australia, Canada, Brazil) is preferred

Minimum Requirements:

  • Bachelor’s Degree (BA/BS) or equivalent, preferably in a life science or related discipline.
  • Minimum of two years working in Quality Assurance.
  • Evidence of training to the following standards and regulations:
    • CFR 820
    • ISO 13485:2016
  • Must have working knowledge of all elements of a Quality System, in particular the Internal Audit and Corrective and Preventive Action sub-systems.
  • Strong computer skills including MS Office applications are required. 

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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#CBD#

We look forward to receiving your application. If you share our passion and believe that saving lives is the greatest job in the world, then we look forward to receiving your application. We hope you will join us on our journey to become the world’s most desired medtech company.

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