Senior Supplier Quality Engineer Consultant

Are you ready to join a
world leader
in the exciting and dynamic fields of the
Pharmaceutical and Medical Device industries
?
PQE Group
has been at the forefront of these industries
since 1998
, with
40 subsidiaries
and more than
2000 employees in Europe, Asia and the Americas
.

Due to our constant growth, we are looking for a
Senior Supplier Quality Engineer
to support our projects in
France
.

We need a consultant who who can reinforce the team in managing the quality relationship with the suppliers, throughout the supplier lifecycle from supplier qualification to the manufacturing and to post market life cucle, by considering the customer specific requirements and offering technical support to ensure the fullfilment of the company obectives in compliance with established standards and regulations (e.g.: FDA 21 CFR Part 820, ISO13485, European Medical Device Directives 90/385/EEC and 93/42/EEC, European MDR 2017/745, Japan PAL and ordinance #169, China regulation, Canada MDR SOR/98-282, TGA and any other applicable regulation).

You will be responsible for

• Ensure Company compliance with the Supplier Management procedure
• Ensure that suppliers provide services respecting applicable regulations and specifications
• Identify and help implement improvement to supplier quality management tools and processes
• Work with the supplier on their understanding of CRM products, their intended use, and regulatory requirements
• Supporting CRM improvement initiatives related to suppliers (i.e. Purchasing group in Cost Reduction projects) Pre-production activities
• Contributing to the selection of suppliers with R&D, Operation and Purchasing department and qualification through audit process
• Collaborating with R&D in the development and communication to suppliers of component specification documentation, review and approve components specifications, ensuring that specifications cite critical characteristics and required process controls, when required.
• Technically develop the supplier throughout the product development process to assure launch readiness, including development of supplier technical capabilities & control plans. Establish quality requirements for suppliers and initiate and manage quality agreements, when required.
• Ensure that proper risk control measures are implemented and monitored at the supplier.
• Assist in developing incoming inspection plans for components, assemblies and/or finished devices.
• Use appropriate methods such as statistical process control (SPC), advanced quality process (AQP) tools andmetrics proactively to identify and implement improvement opportunities. Post-production activities
• Initiate and manage Supplier Corrective Actions (SAR) to ensure complete, timely and effective root cause analysis and corrective action implementation is performed promptly with the appropriate stakeholders.
• Applying risk management tools and concepts in the decision-making process for any identified opportunities, as well as for the prevention of non-conformances to occur at supplier level.
• Gather, monitor and analyze supplier quality data to identify trends and implement corrective action (Scorecards, KPIs, etc.) and prepare the data for the Quality Management Review.
• Manage Supplier Change Notices and provide leadership in managing the supplier change control process.
• Participate in the supplier quality audit process according to the pre-established calendar and ensure followup of corrective actions to audit findings

About you

• Available to travel on site
• Fluent in english

Next Steps

Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview.

If there's a positive match, a technical interview with the Hiring Manager will be arranged.

In the case of a positive outcome coming from Hiring Manager interview, recruiter will contact you for further steps or to discuss our proposal.

Alternatively, if the outcome is negative, we will contact you to halt the recruitment process.

Working at PQE Group

As a member of the PQE team, you will be part of a
challenging, multicultural company that values collaboration and innovation
. PQE Group gives you the
opportunity to work on international projects
, improve your skills and interact with colleagues from all corners of the world.

If you are looking for a
rewarding and exciting career
, PQE Group is the perfect place for you.

Apply now and take the first step towards an amazing future with us.