Manager, Quality Systems

Enable Injections Inc. • Sharonville, OH

43d • Onsite

About The Position

QUALIFICATIONS Required: 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 Preferred: Certified Quality Auditor (CQA) Six Sigma or Project Management Professional certification is a plus Skills & Competencies: Ability to lead quality systems group by providing daily direction, resource planning, and develop 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 internal and external to the organization Competent with word processing, spreadsheets, and statistical analysis software packages (preferably Word, Excel, and Minitab) Physical Requirements: 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. RESPONSIBILITIES: 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 Reporting routine Quality metrics to the Senior Management team

Requirements

• 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
• Ability to lead quality systems group by providing daily direction, resource planning, and develop longer term strategies
• Establish departmental metrics and goals in support of organizational strategic goals
• 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 internal and external 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.

Nice To Haves

• Certified Quality Auditor (CQA)
• Six Sigma or Project Management Professional certification is a plus
• Prefer SAP experience

Responsibilities

• 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
• Reporting routine Quality metrics to the Senior Management team

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 101-250 employees