Quality System and Regulatory Compliance Manager in Maurens-Scopont, France at Cepheid

Date Posted: 6/6/2019

Job Snapshot

Job Description

Job ID: CEP003785

About Us

At Cepheid, we are passionate about improving healthcare through faster, more accurate diagnostic tests. With our GeneXpert® System, we’ve taken the most sophisticated molecular technology and packaged it into an automated, easy-to-use format that has quickly become the platform of choice worldwide. From the largest laboratories to small physician offices, our game-changing solution delivers critical answers when clinicians and patients need them most. Through strong molecular biology capabilities and ongoing product innovation, we are focused on developing tests for healthcare-associated infections, sexual health, critical infectious disease, virology, and oncology applications. Come join our vision for a better way and help make life better for us all! For more details, visit us at www.cepheid.com or follow us on Twitter (@CepheidNews).


Description

POSITION SUMMARY:

• Manage Quality Systems processes and related deliverables in conjunction with Company objectives and Regulatory requirements.
• Mentors and provides ongoing teaching, guidance and assistance of process owners, CAPA stakeholders, internal auditors, managers and their team.

ESSENTIAL JOB RESPONSIBILITIES:

• Lead and develop Cepheid Quality System and Regulatory Compliance team ensuring Cepheid has continuous compliance with the corporate Quality Policies and applicable regulatory requirements.
• Independently deploy and maintain the applicable global quality system policies and procedures in Cepheid Europe SAS.
• Plan and conduct Quality System Management reviews for Cepheid Europe SAS
• Being the site Quality Management Representative for Cepheid Europe SAS,
• Control and approve QSM local document changes to ensure compliancy with ISO and QSR requirements
• Manage the site internal audit program and coordination with the internal auditor team
• Manage CAPA process and ensure compliant and timely deliverables of corrective and preventive actions.
• Participate in Cepheid continuous improvement process in conjunction with all departments
• Maintain ISO 13485 compliance and current certification,
• Being the deputy of the designated person in charge of the reactovigilance.
• Responsible to ensure:
•The control and release of the material supplied by external vendors,
•The final products (instrumentation-related products or reworked final products) are released systematically through the QA batch review process.
• Maintains and instructs employees in quality techniques and philosophy.

TRAINING RESPONSIBILITIES: (REQUIRED)
• Complete all assigned and required training satisfactorily and on time
• For people managers, ensure your associates attend and complete all required trainings satisfactorily and on time.

Job Requirements



Qualifications

MINIMUM REQUIREMENTS:

Education or Experience (in years):
• Bachelor Degree in field with 5 years of experience in the medical devices industry (IVD can be a plus) OR
• Master Degree or Diploma in Quality Management with 3 years of related experience(IVD can be a plus)

Knowledge and skills:
• Excellent verbal and written communication skills (French and English)
• Knowledge of International Organization for Standardization ISO13485
• Knowledge of International regulations QSR for USA, CE Directive and Regulation for Europe.
• Excellent planning and organizing skill
• Exceptionally strong team player with excellent interpersonal and communication skills
• Able to confidently deal with ambiguous issues and provide input towards suitable actions.

The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job.

Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.
Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.