Stryker Quality Assurance Methods - Manager in Lund, United States
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.
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.
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.
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
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)
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%
Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com