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 person directs the execution & performance of the Augmented Beauty Device QMS and QA activities. This includes establishing a Medical Device QMS that is FDA compliant & leading company to secure a MDSAP (Medical Device Single Audit program certificate as well as ISO 13485 and Medical Device Regulation certificates. Provides clear guidance and training for this area & the company overall by ensuring clear policies, procedures, instructions, forms, & objectives are provided. Coordinates objectives & strategies with other leaders so that high-level objectives are met. Monitors training and growth of individuals.
DUTIES AND RESPONSIBILITIES
- Develop and manage Quality Management Systems and Documentation Control organization
- Lead company to MDSAP /ISO 13485 / MDR certification
- Establish and maintain FDA compliance to 21 CFR 820, Quality System Regulation
- Promote awareness of customer and regulatory requirements throughout the organization
- Report to top management on the performance of the QMS & any need for improvement
- Ensures clear, concise, & accurate policies, procedures, instructions, forms, & objectives are established & maintained. Guide company in the correct implementation of the QMS.
- Ensure the Quality Policy is communicated and facilitate Management Review Meetings
- Monitor and report on Key Performance Indicators (KPI's)
- Ensure the Product Risk Management System is established and maintained per ISO 14971:2012
- Influence Design for Manufacturability and Quality
- Enforce robust Product System Test, Quality Controls and Assurance both internally and at external suppliers
- BA/BS undergraduate degree in life sciences, engineering or business Required. Advanced Degree desired
- 10+ years quality systems and regulatory experience. Advanced knowledge of 21 CFR 820 and ISO13485 or equivalent required
- Progressive & proven record of leadership and managing quality systems & regulatory with global responsibility and establishing long term strategic growth initiatives
- Experience involving product quality and manufacturing process management in electronic device industries
- Experience in dealing with both domestic and overseas suppliers in new product/process development and quality management
- High level of personal/and professional integrity and trustworthiness with strong work ethic and the ability to work independently
- Excellent interpersonal communications and presentation skills
- Ability to develop and manage a high performance team focused on accountability and meeting and exceeding expectations
- Ability to lead, influence, create and work within cross-functional team environments
- Assertive, take-charge, proven manager with a strong results orientation, positive “can do” attitude and a sense of urgency to get things done
- Lead Auditor certification, highly desirable
- ASQ certification as CQE desirable
- Electronics Device industry background is a plus
- Green/Black Belt certification desirable
- 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.