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Bausch + Lomb · 1 day ago

Supplier Quality Specialist - External Auditor

Clearwater, FL

Full-time

Onsite

Senior Level

5+ years exp

Bausch + Lomb is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people. They are seeking a Supplier Quality Specialist to manage supplier relationships, conduct audits, and ensure compliance with quality systems and regulatory standards.

Health CareHealth DiagnosticsMedical

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

Quality auditing certificationGMP/ISO quality systemsSupplier auditsRegulated medical device experienceInterpersonal skillsWritten communicationOral communicationCross-functional collaboration

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

Benefits

Employee Benefits: Bausch + Lomb

Company

Bausch + Lomb

Glassdoor3.6

We're a leading global eye health organization that is dedicated to protecting and enhancing the gift of sight for millions of people around the world – from the moment of birth through every phase of life.

Founded in 1853

Rochester, New York, USA

10001+ employees