Sr. Quality Assurance Manager

Job Description

• Comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position.
• Quality Management System (Good manufacturing practices and Good Distribution Practices) – implement and maintain a QMS for distribution and supporting activities, including deviations, investigations, complaints, change controls, and corrective and preventive actions.
• Management of outsourced activities and suppliers/vendors, including distributors and wholesalers.
• Complete all planned Quality & Compliance training within the defined deadlines.
• Identify and report any quality or compliance concerns and take immediate corrective action as required.
• Identify and ensure timely closure of corrective and preventive actions for the region.
• Participate and represent the Region in regional staff meetings/events.
• Mentor and coach direct reports to successful understanding and implementation of Quality System Requirements.
• Timely communication of all quality concerns, initiatives, and information to the site Management team.
• Meet specific quality metrics and/or milestones as defined in annual business objectives.
• Operate regional inspection and internal audit programs and manages follow up activities to close Nonconformities.
• Operate supplier audit program and timely closure of audit actions (for Direct and Indirect markets).
• Management of illicit practice incidents and ensure proper escalations.

Required Qualifications

• Significant experience in the Quality & Healthcare Quality. Knowledge level is comparable to a Master’s degree from an accredited university or college ( or a high school diploma with relevant experience).
• Bachelor’s degree in Engineering, Medical Device Technology or Scientific Field (or High School diploma/GED and a minimum of 10 years work experience and understanding of product development, manufacturing, quality control and servicing in a medical equipment environment).
• Minimum 5 years professional experience and understanding of product development, manufacturing, quality control and servicing in the medical equipment or pharmaceutical industry.
• Minimum 3 years supervisory/ management experience, including hiring, training, coaching and performance management activities.
• Hands-on experience with FDA, QSR, ISO, MDD and/or other international quality systems requirements.
• Proven track record in performing external and internal audits.
• Ability to read, analyze, and interpret business plans, technical procedures and governmental regulations.
• Effective report, business correspondence and procedure writing skills.
• Good problem identification, multivariable analysis and creative resolution aptitude.
• Proven process development and project management skills.
• Strong computer skills.
• Ability to communicate using English, and French OR Arabic.

Desired Characteristics

• Demonstrated experience working in a cross-functional environment and proven ability to influence and build consensus among multiple functions.
• Experience in a global, matrixed organization structure.
• Professional certification as a Lead Auditor.
• Six Sigma training and/or certification
• Team player with a global mindset.
• Strong Change Acceleration skills.
• Experience in building a Quality System from ground up.