Senior Supplier Quality & Compliance Analyst

Penumbra; Alameda (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Penumbra is seeking a Senior Supplier Quality & Compliance Analyst to manage external suppliers through audits and ongoing evaluations. You will lead supplier quality activities, act as lead auditor, and support supplier development to improve quality and meet business objectives.

The role requires a Bachelor’s degree in science with 7+ years in quality systems, strong knowledge of QSR/ISO, GMP, and robust communication skills.

Qualifications

• A Bachelor's degree in science or related field, with 7+ years of quality systems experience preferably in a medical device environment, equivalent combination of education and /or demonstrated experience.
• Experience in statistical methodologies and analysis
• Working knowledge of the QSR, ISO and other applicable regulations and laws
• Ability to manage multiple, complex priorities within demanding timeframes with attention to detail.
• Familiar with current Good Manufacturing Practices within a medical device environment (or equivalent industry).
• Strong oral, written, and interpersonal communication skills
• Proficiency with MS Word, Excel, and PowerPoint
• Training and experience in performing

Responsibilities

• Organize and facilitate the external supplier audit program by analyzing data, coordinating audit logistics, and ensuring documentation is completed per QMS requirements
• Independently analyze supplier compliance against applicable requirements and determine or recommend appropriate audit findings and follow-up actions.
• Act as auditor/lead auditor within the designated auditing team on supplier audits.
• Develop strategic audit plans for suppliers selected for audit, referencing applicable procedures and aligning with Supplier Quality Engineering on audit scope.
• Assess supplier changes and review previous audits and supplier performance.
• Conduct audit activities in a professional manner. Review supplier procedures against internal and external compliance requirements.
• Author supplier audit reports following QMS requirements and provide a summary of the audit. Draw conclusions regarding compliance status and present potential findings for leadership review. Provide well-founded recommendations for improvement. Run closing meetings and review process for audit follow-up activities.
• Evaluate the adequacy of supplier corrective-action responses and determine whether additional evidence, remediation, or escalation is required to ensure any nonconformances are sufficiently addressed.
• Manage the development and maintenance of the supplier audit schedule in alignment with leadership and Supplier Quality Engineering to support ongoing quality improvement efforts and business objectives.
• Lead the preparation, review, and update of Supplier Quality Agreements by developing criteria, ensuring alignment with regulatory standards, and collaborating with suppliers to address quality issues.
• Maintain the Approved Distributor List (ADL)
• Proactively identify and collaborate with suppliers to resolve day-to-day quality and compliance issues and address potential issues before they escalated.
• Maintain records that support Supplier Quality.
• Own, manage, and drive NCRs and CAPAs, as necessary, in support of Supplier Quality Compliance functions.
• Develop, recommend, and implement improvements to supplier quality procedures, work instructions, and controls based on audit trends, compliance risks, and supplier performance data. Manage and release ECOs to support process improvements and resolve supplier-related issues.
• Interface with other internal departments, customers, and suppliers on quality-related issues
• Remain current on industry requirements and trends related to quality compliance in the medical device industry.
• Responsible for timely communication with suppliers and distributors.
• Mentor junior Supplier Quality & Compliance Analysts.

Skills

Statistical analysis

QSR/ISO knowledge

Time management

GMP knowledge

Communication skills

Education

Bachelor's degree + 7+ years in quality

Tools

MS Word

Excel

PowerPoint

Job description

As a Senior Supplier Quality & Compliance Analyst, you will engage in the management of external suppliers through supplier audits and periodic evaluations of suppliers. The Senior Supplier Quality & Compliance Analyst is responsible for leading ongoing supplier quality activities is responsible for leading ongoing supplier quality related activities agreements, acting as lead auditor during supplier audits and supporting supplier development initiatives, in alignment with Procurement and Supplier Quality Engineering, to improve quality and meet business objectives.

What You’ll Work On

• Organize and facilitate the external supplier audit program by analyzing data, coordinating audit logistics, and ensuring documentation is completed per QMS requirements
• Independently analyze supplier compliance against applicable requirements and determine or recommend appropriate audit findings and follow-up actions.
• Act as auditor/lead auditor within the designated auditing team on supplier audits.
• Develop strategic audit plans for suppliers selected for audit, referencing applicable procedures and aligning with Supplier Quality Engineering on audit scope.
• Engineering on audit scope. Assess supplier changes and review previous audits and supplier performance.
• Conduct audit activities in a professional manner. Review supplier procedures against internal and external compliance requirements. *
• Author supplier audit reports following QMS requirements and provide a summary of the audit. Draw conclusions regarding compliance status and present potential findings for leadership review. Provide well-founded recommendations for improvement. Run closing meetings and review process for audit follow-up activities.
• Evaluate the adequacy of supplier corrective-action responses and determine whether additional evidence, remediation, or escalation is required to ensure any nonconformances are sufficiently addressed.
• Manage the development and maintenance of the supplier audit schedule in alignment with leadership and Supplier Quality Engineering to support ongoing quality improvement efforts and business objectives.
• Lead the preparation, review, and update of Supplier Quality Agreements by developing criteria, ensuring alignment with regulatory standards, and collaborating with suppliers to address quality issues.
• Maintain the Approved Distributor List (ADL)
• Proactively identify and collaborate with suppliers to resolve day-to-day quality and compliance issues and address potential issues before they escalated.
• Maintain records that support Supplier Quality.
• Own, manage, and drive NCRs and CAPAs, as necessary, in support of Supplier Quality Compliance functions.
• Develop, recommend, and implement improvements to supplier quality procedures, work instructions, and controls based on audit trends, compliance risks, and supplier performance data. Manage and release ECOs to support process improvements and resolve supplier-related issues.
• Interface with other internal departments, customers, and suppliers on quality-related issues
• Remain current on industry requirements and trends related to quality compliance in the medical device industry.
• Responsible for timely communication with suppliers and distributors.
• Mentor junior Supplier Quality & Compliance Analysts.

What You Contribute

• A Bachelor's degree in science or related field, with 7+ years of quality systems experience preferably in a medical device environment, equivalent combination of education and /or demonstrated experience.
• Experience in statistical methodologies and analysis
• Working knowledge of the QSR, ISO and other applicable regulations and laws
• Ability to manage multiple, complex priorities within demanding timeframes with attention to detail.
• Familiar with current Good Manufacturing Practices within a medical device environment (or equivalent industry).
• Strong oral, written, and interpersonal communication skills
• Proficiency with MS Word, Excel, and PowerPoint
• Training and experience in performing