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Enable Injections, Inc. · 2 weeks ago

Manager, Quality Systems

Cincinnati Metro

Full-time

Onsite

Mid, Senior Level

7+ years exp

Enable Injections, Inc. is a company focused on quality systems within the medical device industry. They are seeking a Manager for Quality Systems to lead the quality systems group, manage several quality system processes, and ensure compliance with industry standards.

Health CareLife ScienceManufacturingMedical Device

Hiring Manager

Carlie Dellecave

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

Qualification

GXP experienceQuality Assurance systemsMedical device experienceCertified Quality AuditorSix Sigma certificationSAP experienceAnalytical thinkingTechnical experienceStatistical analysis softwareCommunication skillsCollaboration skills

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

Company

Enable Injections, Inc.

Cincinnati-based Enable Injections is a global healthcare innovation company developing and manufacturing drug delivery systems designed to improve the patient experience.

Founded in 2010

Cincinnati, Ohio, USA

201-500 employees