Bausch + Lomb France · 1 week ago
Supplier Quality Specialist - External Auditor
Clearwater, FL
Full-time
Onsite
Senior Level
5+ years expBausch + Lomb is a leading global eye health company dedicated to protecting and enhancing sight. They are seeking a Supplier Quality Specialist - External Auditor to manage supplier relationships, conduct audits, and ensure compliance with quality systems and regulatory standards.
Medical Device
No H1B
Responsibilities
Facilitate audits of contract manufacturers and suppliers relative to corresponding quality systems and regulatory standards. Maintain current supplier documentation and files
Audit activities will include planning, execution, documentation, and reporting; identify and communicate non-conformities, observations, and opportunities for improvement; prepare detailed audit reports and proactively track, verify, and ensure the effectiveness of corrective and preventive actions (CAPAs) resulting from audit findings
Responsible for the communication and documented integration of external compliance- related information including changes in regulations, new guidelines and guidance documents and other information from regulatory authorities and trade organizations
Inform management on an ongoing basis about the compliance status in all areas of the business and highlight any delays and resource constraints that could adversely impact the business
Identify gaps or risks, provide recommendations for corrective actions, and support continuous improvement initiatives to uphold product safety, quality, and regulatory compliance
Actively participate in Notified Body audits (MDSAP, ISO certifications, etc.), ensuring required documentation and personnel are prepared and available
Collaborate with cross-functional teams to implement quality improvements and ensure audit readiness and compliance across departments
Other applicable duties as assigned
Qualification
Required
Bachelor's degree in technical field required. Experience and certification may be considered in lieu of a degree
Certification in quality auditing (e.g., ASQ CQA, ISO 13485 Lead Auditor)
5-7 years' experience in Quality related function in a pharmaceutical and or medical device environment, responsible for developing and implementing quality systems
Minimum 3 years auditing GMP/ISO quality systems
Preferred
Highly developed interpersonal skills as well as strong written and oral communication skills
Demonstrated hands on ability to lead cross functional audit teams
Experience interacting with the regulatory bodies during inspections is also desirable
Working knowledge and experience in a regulated medical device or pharmaceutical industry and experience with managing external agency audits necessary
Company
Bausch + Lomb France
Bausch+Lomb, c’est avant tout un laboratoire dédié à la protection et à l’amélioration de la vue de millions de personnes dans le monde, pour les accompagner dès leur naissance et à chaque phase de leur vie.
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase