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Quality Engineer, Supplier Quality Management

Cleveland, OH

Full Time

Mid Level

Position Overview

The Quality Engineer, Supplier Quality Management performs routine activities associated with the

Supplier and Material Management programs in support of a cGMP Operation. This position supports the

maintenance of the supplier management quality system in support of a cGMP Operations. The Quality

Engineer, Supplier Quality Manager will report to the Manager, Quality Assurance or above and will

support the supplier management program as the Quality Assurance representatinve.

Essential Duties and Responsibilities

Position is Day Shift

• Leads and conducts supplier and service provider audits. This includes providers for clinical and

operational activities. Includes risk assessments, scheduling, preparing documents prior to the audit, and

managing audits.

• Leads supplier qualification activities and monitors supplier/service provider performance.

• Collaborates and approves raw material and packaging component specifications.

• Reviews and approves supplier change requests.

• Initiate and facilitate Supplier Corrective Action Requests.

• Supports Supplier Quality Management initiatives.

• Coordinates and responds to Supplier Audit Responses.

• Leads discussions on observations with management on audit corrective actions and responses.

• Leads audit teams in resolving supplier qualification and/or disqualification actions.

• Works with purchasing to address Supplier Notifications of Change(s). Reviews, tracks and approves
supplier change requests.

• Review Quality Agreements and help maintain the quality agreement program and life cycle.

• Leads and/or performs internal QA Compliance audits

• Trains site personnel on auditing and audit readiness.

• Writes and maintains supplier management SOPs as needed.

• Works with R&D on new product or technology transfer product audits.

• Provides oversight for the medical device QMS and CMO quality relationship for Abeona.

• Supports Regulatory Authority Compliance audits

• Performs other related job duties as required.

Qualifications

· Minimum of a Bachelor’s of Science degree in related field and/or equivalent experience.

· Minimum of five (5) years or more related experience in a Pharmaceutical GMP regulated

manufacturing environment.

· Five (5) or more years experience performing audits (internal or external) preferred.

· Quality or compliance certification (ASQ CQA or CQE) preferred.

· Travel up to 25% of the time.

Competencies

· Excellent organizational skills, attention to detail, and Good Documentation Practices.

· Proficiency in MS Word, Excel, Power Point, Microsoft Office 365 and other applications.

· Must possess effective interpersonal, verbal, and writing skills, patience, professionalism, and the

ability to effectively interact and communicate with internal staff and management.

· Comfortable in a fast-paced, patient-focused manufacturing environment with minimal direction and able to adjust workload based on changing priorities. · Strong ability to interpret technical procedures, SOPs, and regulatory regulations · Able to learn new computer systems / programs quickly · Knowledge of GCP, GLP, GMP, ICH and ISO regulations/requirements.

Working Accommodations
This is a flexible work role. This position is eligible to work remotely and be on site needed.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to

successfully perform the essential functions of this job. Reasonable accommodations may be made to

enable individuals with disabilities to perform the essential functions. While performing the duties of this

job, the employee is regularly required to experience prolonged sitting, some bending, stooping, and

stretching. Hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier,

telephone, calculator, and other office equipment is required. A normal range of hearing and vision

correctable to 20/20 is required. Occasional lifting up to 20 pounds is required.

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