Manager R&d Quality - Pluvigner, France - BAXTER

BAXTER

Entreprise vérifiée

Pluvigner, France

il y a 3 semaines

Posté par:

Sophie Dupont

beBee Recruiter

Description

This is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world.

You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

Summary

This is where you as the Product Quality Manager are the quality R&D leader for all design & development areas of our Medical Device products, being part of our important mission to save and sustain lives.

This position provides leadership for the Product Quality Engineers at the Pluvigner and Lulea sites, and with further responsibilities within the PSS division to enable the organization to achieve highest Quality goals in terms of product R&D quality, process and regulatory compliance and to the Baxter quality policy.

Essential Duties and Responsibilities

Manager for Product Quality (R&D Quality) in the Patent Support Systems division for medical devices inside the hospital environment like ICU and Med-Surg Hospital Bed Frames & Surfaces, Surfaces/wound therapy, Hospital Patient Lift Systems, Contact Free Continuous Monitoring (HR/RR), System Integrations
Supporting all Product Quality priorities for the sites Pluvigner (France), Lulea (Sweden), Batesville (US) on all Quality and R&D programs within the HST segment.
Provide quality assurance support and oversight for product design activities including Design and Development Planning, Design Input, Design Output, Design Review, Design Verification and Validation, Design Transfer, Design Changes.
Partner with Sustaining Engineering and Research & Development to ensure the designs are thorough and robust and go beyond the process to achieve highest quality.
Ensure quality design aspects of complaints, CAPAs, Field Actions etc. are being handled with highest priority to ensure patient safety, highest quality and compliance.
Collaborate with global R&D, Product Quality/Design Assurance and RA teams to drive continuous improvement, including development of standard work, striving for a worldclass Product Development Process.
Integration support and harmonization lead in alignment with other QMS inside the Healthcare Systems and Technology (HST) segment to align to "One QMS".
Supporting of the quality systems procedures and managing compliance in the total QMS through various control mechanisms such as Management Reviews, NCR/CAPA review, complaint trending, etc.
Improvement of the different QMS with focus on Design & Development to streamline for high priorities, such as Software Connectivity.
Audit support and Lead for internal, corporate, and external audits as needed.
Understanding and assuring conformance to regulations in the area of responsibility and beyond.
Improvement of complaint handling process in collaboration with R&D, service and marketing.
Implementation and improvement of Product Quality Engineering team responsibilities, such as complaint investigations, managing continuous improvement projects with the objective of achieving quality, reliability and cost improvements, NCR/CAPA support, etc.
Develop budget and ensure adherence to the it
Manage the coaching, training and development of subordinates.

Qualifications

Bachelor's degree in Engineering or Computer Science or similar field.
5+ years' experience in Quality, Software Engineering or related field which should include 12 years of supervisory experience.
Experience in assessing and developing procedure to meet Software Connectivity/Digital Health regulatory requirements and guidance's.
Experience with FDA inspections. ISO/ Notified Body audits is a plus.
Professional certification such as ASQ, IEEE, Six Sigma, LEAN manufacturing or achievement of certification. ASQ CSQE preferred.
Strong communication and leadership skills.
Strong, results driven, project management skills.
Excellent problemsolving skills and the ability to teach others.
Capable of clearly presenting and justifying quality position and requirements to management.

Reasonable Accommodations

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To learn how you can protect yourself, review our Recruitment Fraud Notice.

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