For more than a century, L’Oreal has devoted its energy, innovation and scientific excellence solely to one business: Beauty. A business rich in meaning, it enables all individuals to express their personalities, gain self-confidence and open up to others. Beauty is our language, a universal language. Joining L’Oreal means joining our mission of offering women and men worldwide the best innovation by meeting the infinite diversity of beauty needs and desires all over the world. A company founded on Science, we continually explore new territories and invent products of the future, while drawing inspiration from beauty rituals the world over. Our formula: Diversity Plus Inclusion equals Innovation and Success. Drawing on the diversity of our multinational teams and the richness and the complementary of our brand portfolio, Beauty remains our commitment. L’Oréal has made the universalization of beauty its project for the years to come, offering beauty for all. At the heart of our activities lies the ambition to lead by example with high ethical standards and the determination to be seen as a good corporate citizen with goals that are not only business oriented but socially responsible. As a leader, we must preserve the beauty of the planet and contribute to the well-being of our employees and of the communities in which we are present. We invite you to explore the opportunities to help us perform this important mission.
This position is responsible for designing, implementing and maintaining the Quality Management System (QMS), for Medical Devices compliant with FDA 21 CFR 820 and the most current version of ISO 13485 plus the additional regulatory requirements for applicable markets. The Quality Systems Manager represents the QMS to the business and external parties. The Medical Devices are regulated consumer products, including electronic devices and OEM consumable products, supplied to both to US and International markets.
DUTIES AND RESPONSIBILITIES
- Develop, manage and maintain the Quality Management System, including changes
- Assure compliance with FDA and other regulatory agencies
- Maintain ISO 13485 certification and achieve MDSAP (Medical Device Single Audit Program) certification
- Manage and ensure compliance for the Corrective and Preventive Action (CAPA) program.
- Manage QA internal audit function, ensuring compliance with standards and regulations are maintain throughout the organization
- Manage the Document Control function, ensuring integrity in life cycle management of products.
- Develops high performing team members to drive personal development.
- Manage the Employee QMS Training process, ensuring that employees trained to appropriate procedures, standards and regulations, in a timely and effective manner.
- Responsible for electronic PLM tool used for product documentation, QMS system and quality records
- Responsible for external document vendor and internal access (standards)
- Responsible for the continual collection and analysis of QMS data, to ensure the health of the QMS.
- Responsible for the Management Review system; to include data collection, scheduling, and meeting minute generation.
- Any other duties and projects as assigned.
- Bachelors Degree required. Degree in a scientific or engineering discipline desired
- 2+ years’ management experience within the QMS system, or related role required
- 5+ years’ experience in a regulated environment required; to include audit experience; knowledge of FDA 21 CFR 820 and ISO 13485:2016, working knowledge of MDSAP, preferred
- Experience at interfacing with FDA and/or other such regulatory agencies, a plus
- Experience at planning and leading an organization through ISO 13485 certification and surveillance audits
- Experience with QMS Software verification and validation, preferred
- Ability to work effectively and cooperatively with other departments, supporting the QMS
- Strong interpersonal and communication skills
- Interacts effectively – Demonstrates collaborative engagement, builds trust, strong communicator
- Leads with human sensitivity – shares know-how expertise, knowledge, procedures with team and stakeholders utilizing an effective coaching approach
- Demonstrates entrepreneurship – takes ownership of his/her mission and contribution and develops drives innovative solutions
- Displays sensitivity to our “métier” – drives his/her contribution to achieve customer satisfaction
- Manages complexity – meets deadlines without giving up on quality and has a proven track record of navigating complex organizational dynamics
- Achieves results with integrity – prides themselves on producing ethically sound work
We are an Equal Opportunity Employer and take pride in a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, sexual orientation, national origin, age, marital or veteran status, medical condition or disability, or any other legally protected status.
If you require a reasonable accommodation to complete an application for a recognized disability under applicable law, please email USApplicationAccommodation@support.lorealusa.com
. Please note this email will only respond to specific requests for assistance completing the application as a request for accommodation for a disability. All others will not be considered.