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QC Specialist I - Merrimack, NH

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Date: Sep 23, 2022

Location: Merrimack, NH, US

Company: Getinge

 

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.

 

  • QC Support (80%)
    • Reviews Device History Records (DHRs) for completion and verification of compliance in accordance with the Requirements of the Device Master Record (DMR).
    • Responsible for all sterile product release and review of sterilization records.
    • Initiates nonconformance reports (NCRs), aids in investigation and participates in Material Review Board (MRB) meetings.
    • Reviews change orders for accuracy and determines impact of the changes on QC operations.
    • Performs containment activities, including production holds and product ship holds.
    • Assists with training the QC operations group on changes to procedures and visual aids affecting inspection, testing or record review, as needed.
    • Performs DHR post-release review and prepares batch records for scanning and storage.
    • Operate in a clean room environment as required.
    • Contributes to team effort by accomplishing related duties as requested.
    • Provides overview training to new employees for specific product lines.
  • Cross-functional Support (20%)
    • Identifies and corrects documentation gaps through collaboration with other departments.
    • Supports the QC operations group and acts as a coordinator between QC and Manufacturing as well as new R&D activities.
    • Represents QC on Design Control Quality Plans (DCQPs), Corrective Action / Preventive Action (CAPA) and other special projects as needed.

 

Required Knowledge, Skills and Abilities

    • The ability to perform repetitive tasks with a high level of accuracy.
    • Strong written and verbal communication skills (English).
    • Self-motivated with a high initiative and strong problem solving skills.
    • Demonstrates ability to manage time efficiently.

Minimum Requirements

    • Associates Degree or equivalent experience required.
    • A minimum of four years’ experience working in Quality environment.
    • Strong communication skills (English).
    • Working knowledge of 21 CFR Part 820 and ISO 13485.
    • Strong computer skills with MS Office applications (Word/Excel) required.
    • Ability to work with related software such as Agile, Oracle, SAP and Cognos.

 

#LI-AL1

 

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.

 


Nearest Major Market: Manchester
Nearest Secondary Market: Nashua