Manager, Quality Systems

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• Bachelor’s Degree in Scientific discipline
• Minimum of 7 years of GXP experience
• Minimum of 5 years of experience in the medical device or pharmaceutical industries

• Certified Quality Auditor (CQA)
• Six Sigma or Project Management Professional certification is a plus
• Ability to lead quality systems group by providing daily direction, resource planning and developing longer‑term strategies
• Establish departmental metrics and goals in support of organizational strategic goals
• Prefer SAP experience
• Strong knowledge of medical device manufacturing systems and methods
• Strong ability to collaborate cross‑functionally
• Knowledgeable in implementing and managing Quality Assurance systems and procedures
• Familiar with medical device manufacturing systems and methods
• Possess a good balance of technical experience, analytical thinking, and communication skills for resolving issues internally and externally to the organization
• Competent with word‑processing, spreadsheets, and statistical analysis software packages (preferably Word, Excel, and Minitab)

• Must be able to remain in a stationary position for extended periods of time
• Must be able to gown to access the controlled areas
• Ability to constantly operate a computer and other office equipment, such as printer, telephone, etc.

• Manage several Quality system processes: documentation system, archive, change control, internal audit, training, and audit support
• Lead and support process improvement & efficiency projects, as necessary
• Able to lead audit teams to support external customers, regulatory bodies, and notified body audits; responsible for developing and submitting responses
• Implementation and maintenance of requirements needed to conform to ISO 13485, CFR 820, and MDR
• Review/approval for Quality procedures and records
• Report routine Quality metrics to the Senior Management team