Quality Assurance Methods - Manager in Lund at Stryker Corporation

Date Posted: 8/8/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Lund
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    8/8/2018
  • Job ID:
    R402507

Job Description

GENERAL SUMMARY:


Quality & Regulatory Affairs Manager is responsible for Jolife AB’s Quality Management System, from  planning and process design to implementation and effectiveness follow up. The position is also responsible for ensuring laws and regulations are implemented and maintained, specifically European Medical Device Regulations and United States CFR 21, subchapter H, Medical Devices.

The position reports to the Physio Control Head of Quality and is part of the Jolife Management Team. The position is based at the development site of LUCAS (Jolife AB) in Lund, Sweden.


MAJOR DUTIES/RESPONSIBILITIES:

  • Management representative regarding quality and regulatory related issues.
  • Plan, implement and maintain a quality management system in the company that is effective and can be certified by those countries where Jolife’s products are present.
  • Report to Management on the performance of the Quality Management System and any need for improvement.
  • Convene and Chair Management review meetings.
  • Plan, perform and maintain registrations of Jolife´s products on new and emerging markets.
  • Ensure that laws and regulations concerning Jolife´s products are available and communicated.
  • Non-conformance handling.
  • Plan and perform quality audits.
  • Provide oversight for supplier controls as required.
  • Monitor outcome of quality processes out-sourced to Physio-Control and Stryker; Complaint, CAPA, Service, Supplier Controls, etc
  • Convene and Chair QRB meetings.
  • Release products for delivery after manufacturing.
  • Re-start production when identified quality issue has been sufficiently assessed and possible corrective actions implemented as applicable.
  • Drive the integration of Jolife’s QMS into corporate QMS.


BASIC QUALIFICATIONS

  • University degree (or of an equivalent course of study) in natural sciences, medicine, pharmacy, engineering or another relevant discipline and at least two years of professional experience in regulatory affairs or in quality management systems relating to medical devices,
  • and  minimum seven years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
  • Knowledgeable in Regulatory Affairs; Laws (US, EU, Canada), Regulations and Standards (ISO 13485).
  • Solid analytical skills, fluent in writing (English) and MS Office

PREFERRED/DESIRED QUALIFICATIONS

  • Trained and experienced in Risk Management
  • Trained and experienced in Quality Auditing
  • Driven, systematic personality with passion for structure and processes.
  • Excellent communication presentation and influence skills, adept in driving alignment and understanding across multiple functions (Engineering, Quality, Operations, Sales etc)


WORKING CONDITIONS:

  • Office environment with extended hours
  • Daily global contact in different time zones
  • Global travelling 15-50 days

Work From Home: No

Travel Percentage: Up to 25%

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