Title: Senior Specialist, Quality Systems

Requisition Number:

Description:

Enable Injections is made up of a team passionate about working together to make people’s lives better. We develop, manufacture, and support the enFuse®, a platform of wearable infusion devices designed to enable subcutaneous self-administration of high-volume therapeutics. Enable employees are technology experts focused on an exceptional patient experience in collaboration with our biopharma partners.

SUPERVISOR’S TITLE: Senior Manager, Quality Systems
PURPOSE OF POSITION: With minimal to no direction of the Senior Manager, Quality Systems, the Senior Specialist, Quality Systems will be responsible for the Quality System program execution. Duties include: supporting the development, implementation and improvement of current and future Quality Management Systems including, but not limited to: Quality System simplification, QMS integration into SAP software system, Internal Audit Program, Notified Body ISO13485 Audits, Customer Audits, Regulatory Body Inspections (including FDA), Document Control, Training, and Management Review
QUALIFICATIONS

Required:
Bachelor’s Degree or equivalent combination of education, training, and experience.
5+ years of experience in Quality Assurance for the pharmaceutical or medical device industries. Preferred: Effective communication skills – verbal and written Strong critical thinking skills and ability to work independently Strong interpersonal skills Experience in record review and material disposition Solid understanding of Quality System requirements (i.e. CAPA, nonconformances, etc.) in a regulated medical device or pharmaceutical environment Strong understanding of device and/or pharmaceutical regulatory and compliance requirements Experience working within SAP (Business Client and ERP, specifically QM module) Skills & Competencies: Excellent analytical abilities, effective communication skills, and effective attention to detail Strong leadership and interpersonal skills. Ability to mentor and coach peers and colleagues. Capable of developing key performance metrics and implementing actions that make improvements in those metrics. Ability to work independently and in a group on a variety of projects. Ability to maintain a high degree of accuracy and attention to detail. Ability to handle a fast-paced, multi-tasking environment, and prioritize effectively. Ability to monitor and report on assigned tasks, goals, and objectives. Competency with electronic document managements systems Proficiency in Microsoft Office (Word, Excel, Outlook, etc.). Experience in developing and conducting presentations with PowerPoint




Physical Requirements: Must be able to remain in a stationary position for extended periods of time Ability to constantly operate a computer and other office equipment, such as printer, telephone, etc. RESPONSIBILITIES: Assures consistent quality of production by developing, overseeing, and enforcing current Good Manufacturing Practices (GMP). Defines and communicates Quality requirements for the Enable Injections Mfg. Facilities (Evendale & Franklin) Conducts and oversees Internal Audit Program of the Quality System. Directly supports the Director, Quality Assurance and Senior Manager, Quality Systems with Notified Body ISO13485 Audits, Customer Audits, and Regulatory Body Inspections (including FDA), Manages the implementation, maintenance, compliance and continuous improvement of Quality Systems (FDA 21CFR Part 820, ISO 13485:2016, CMDCAS, and EU MDR 2017/745) based on established direction and priorities. Contributes to strategic Quality planning and review of the status of the Quality System. Assists with the implementation, maintenance, compliance and improvement of the company Training program. Reports routine Quality metrics to the Senior Management team. Maintains Document Control release, Document Control Storage Room, and electronic Quality System records. Assists with the assembly and execution of Management Reviews Helps develop and deploy quality system training, including GMP, GDP, and FDA Readiness training programs Execute other duties and projects, as assigned by the Director, Quality Assurance and/or Senior Manager, Quality Systems.

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, disability status, protected veteran status or any other characteristic protected by law.