Sr. QA Engineer/Lead Internal Auditor - Merrimack, NH in Merrimack, NH at Getinge

Date Posted: 7/21/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Merrimack, NH
  • Experience:
    Not Specified
  • Date Posted:
    7/21/2018

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 Senior Quality Assurance Engineer/Lead Internal Auditor is responsible for leading, managing, planning, executing and reporting on regulated Quality Assurance activities for internal and 3rd party/external audits. This individual acts as the Lead Auditor and is responsible for performing Internal, domestic and international audits (as appropriate) that ensure compliance with the FDA QSR, ISO, MDD/MDR, CMDR requirements, and other worldwide health authority regulations/guidelines according to local and corporate site procedures. This individual acts as a compliance resource and provides recommendations for corrective action and tracks audit related corrective action commitments until closure.

Job Functions:

  • Sets the schedule (Audit Coordinator) and conducts internal audits as the lead auditor.
  • Manage external third party auditors to conduct internal audits.
  • Ensure that internal audits are completed in compliance with regulatory requirements and documented procedures.
  • Updates audit procedures and associated documents to ensure ongoing compliance with national and international standards and regulations and compliance to corporate procedures.
  • Prepares clear and concise written audit reports and submits them to management in a timely manner.
  • Communicates and monitors identified internal audit non-conformances to ensure they are addressed and closed by the auditee within established timeframes.
  • Manage all aspects of 3rd party audits
    • Coordination and Training for support staff
    • Documentation flow and record retention
    • Room setup & function – front and back
  • Performs re-audits and/or effectiveness verifications as a way of assessing and documenting CAPA Effectiveness
  • Assists in special projects as needed. 
  • Contributes to team effort by accomplishing related duties as requested.

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 external customer and internal contacts.
  • Demonstrated time management and organizational skills; ability to work independently and as part of a team.
  • Strong computer skills including MS Office applications are required. 
  • Working knowledge of medical device regulations, minimally ISO 13485:2016 and CFR 820
  • ASQ Certified Quality Auditor (CQA) is preferred
  • Evidence of training in international regulations (i.e. Korea, Japan, Australia, Canada, Brazil, EU) is preferred

Minimum Requirements:

  • Minimum of five years working in Regulatory Affairs, Compliance or Quality Assurance.
  • Minimum of two years conducting internal audits as a lead auditor to CFR 820 and ISO 13485
  • Evidence of training to the following standards and regulations:
    • CFR 820
    • ISO 13485:2016
  • Evidence of training in auditing techniques

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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