Supplier Quality Specialist - External Auditor

Supplier Quality Specialist - External Auditor

Join to apply for the Supplier Quality Specialist - External Auditor role at Synergetics

This position may be available in the following location(s): US - Clearwater, FL

Manage Supplier relationships from a Quality Standpoint. Lead and conduct supplier audits to determine the state of compliance and drive improvement in Quality Systems.

• 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.

• 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).

• 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.
• 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.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

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To learn more please read Bausch + Lomb's Job Offer Fraud Statement.

Our Benefit Programs:

Employee Benefits:

Bausch + Lomb

Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Seniority level:
Mid-Senior level

Employment type:

Full-time

Job function:
Quality Assurance

Industries:
Medical Equipment Manufacturing