Sr. Quality Engineer

Location: Netherlands

SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!

THE COMPANY

Our client is a professional Medical Devices organization, based in Limburg Netherlands.

A pioneering interventional and diagnostic technology company with a portfolio of advanced products, including the world’s Rapid FFR and High Definition IVUS systems. Global market leader in advanced contrast imaging systems for cardiovascular angiography.

ROLE DESCRIPTION

We are looking for a Senior Quality Engineer, to strengthen our Quality Team.
The Senior Quality Engineer will support the development and maintenance of a robust quality system in compliance with all relevant standards and regulations. Utilize quality system processes to support corporate objectives and continually improve the effectiveness of the quality system.

RESPONSIBILITIES

Manage Quality System for EMEA
- Responsible for compliance with applicable Corporate Policies and procedures.
- Work with all functional areas to ensure that the quality system is effectively implemented and maintained in compliance with relevant standards and regulations.
- Initiate and manage improvement and development projects regarding quality system improvements, change management, qualifications, validations and risk assessments.
- Initiate, review, update and approve quality system documents as needed.
- Review, analyze and report quality system data to identify trends and identify the need for corrective and preventive actions.
- Provide quality system training including CAPA for the organization including field staff and field reports, distributors and 3rd party service organizations.
- Support field organization in order to ensure full compliance to field-based processes.

Manage Corrective & Preventive Action (CAPA) System
- Coordinate Corrective and Preventative Actions (CAPA) to ensure that all CAPA’s are entered into the CAPA system, assigned to the appropriate personnel and completed according to CAPA procedures within the specified times.
- Monitor the status of CAPA’s and report to management.
- Takes part within the global CAPA team.


Manage Audits
- Support and coordinates Notified Body audits and audits from external customers
- Plan, conduct and document quality system internal audits, supplier audits and distributor audits or assessments.
- Approve corrective action plans and verify effective implementation of corrective actions for audit nonconformities.
- Monitor the status of audit CAPA’s to ensure that actions are taken in a timely manner.
- Report to management regarding the results of audits and corrective action status.


Quality Operations support
- Support the Europe Quality processes related to technical service operations, logistics, warehousing and distributions including Receiving Inspections, Incoming Inspections, Non-conforming Product handling, Returned Product Handling, Supplier Quality for both, company devices and non company devices.
- Provide technical support and assist in the investigation, testing and analysis of product complaints for all systems and disposables.
- Support the incoming inspection program, procedures, and sampling methods to ensure product quality and eliminate waste.
- Support installation and validations for hemodynamic systems or other connectivity purposes.

Post Market Surveillance support
- Conduct product complaint and post-market surveillance activities in EMEA for the products. Ensure compliance with EMEA requirement for complaints, adverse event reporting and post-market surveillance.
- Assist with product recall activities.

Other Responsibilities:
- Assure adherence to the environmental management system requirements ISO14001:2015.
- Manages the EHS Documentation Control for the company Europe.

REQUIREMENTS

- Bachelor’s degree or equivalent in engineering/science or a combination of education and experience providing similar skills and knowledge.
- Experience in quality management- and environmental management systems, preferably minimal 3 years of experience in a medical device company.
- Demonstrated knowledge, expertise, and hands-on experience with quality systems regulations and guidelines, ISO13485 and EU MDD93/42/EEC.
- Internal auditor and external auditor experience preferably certified lead auditor.
- Ability to develop clear, concise and timely oral and written reports.
- Balancing business priorities with adherence to standards.
- Good knowledge of the English language.

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Jeroen Evertsen.