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As a Quality Control (QC) Inspection Supervisor at Penumbra, you will combine your natural ability to lead teams and develop top performers with your quality systems knowledge, thus ensuring that our life-saving products adhere to the highest standards of safety and quality.
The QC Supervisor is responsible for supervising the Quality Inspection group that
performs/provides Quality Inspections to Manufacturing and Incoming Quality Inspection requirements.
Specific Duties and Responsibilities:
• Management of the Quality Inspectors including coordinating scheduling for coverage of all
responsibilities.
• Responsible for working with Operations Manager and Supervisors to establish priorities and assign
workload to the Quality Inspection Group.
• Responsible for working with Purchasing to establish priorities and assign workload to the Incoming
Quality Inspectors.
• Responsible for troubleshooting and resolving inspection and equipment issues which arise.
• Support investigations associated with NCRs and CCIs.
• Review, approve and own NCRs, ECOs, DAs and Material Actions
• Coordinate training activities to ensure compliance with regulatory requirements and ensure the
flexibility of utilizing inspectors in all areas of Quality inspection.
• Work with the Quality Engineers, Manufacturing Engineers and R&D Engineers to determine
appropriate support activities for nonconforming goods and new product projects.
• Determine training and personal growth plans for Quality Inspectors.
• Responsible for interfacing with the FDA, State Agencies, and notified bodies during certification,
surveillance and routine ISO audits.
• Participate in Quality Objective teams.
• Evaluate procedures and work instructions for processing improvements.
• Adhere to the Company’s Quality Management System (QMS) as well as domestic and global
quality system regulations, standards, and procedures.
• Ensure other members of the department follow the QMS, regulations, standards and procedures.
• Perform other work-related duties as assigned.
Position Qualifications
• Bachelor’s degree or 4+ years of related experience in the fields of Quality, Biomedical, Life /
Physical Sciences, Document Control, or similar background, or an equivalent combination of
education and experience
• Solid problem analysis and decision-making ability and leadership skills
• Thorough knowledge and understanding of FDA QSR’s, ISO standards, and the MDD
• Computer literacy with preference to Microsoft Professional Office Suite, i.e., Excel, Word, Access,
PowerPoint, and Microsoft Project.
Preferred qualifications
• ASQ certifications for CQIA, CQA, or equivalent preferred
What We Offer:
• A collaborative teamwork environment where learning is constant and performance is rewarded
• The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases
• A generous benefits package that includes medical, dental, vision, and life insurance; a 401(k) match; and an Employee Stock Purchase Plan
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.
If you reside in the State of California, please also refer to Penumbra’s Privacy Notice for California Residents.