| Preferred: - Experience in record review and material disposition
- Experience working within SAP (Business Client and ERP, specifically QM module)
Skills & Competencies: - Effective communication skills – verbal and written
- 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
- 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: - Responsible for providing Quality oversight for established Quality Systems which include Document Control and Records Retention, Training Compliance, and Internal Audit Program
- Assure consistent quality of production by developing, overseeing, and enforcing current Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)
- Define and communicate Quality requirements for the Enable Injections Mfg. Facilities (Evendale & future site)
- Conduct and oversee Document Control and Training Compliance processes of the Quality System.
- Directly supports the Senior Director, Quality and Senior Manager, Quality Systems with Notified Body ISO13485 Audits, Customer Audits, and Regulatory Body Inspections (including FDA),
- Manage 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
- Contribute to strategic Quality planning and review of the status of the Quality System.
- Assist with the implementation, maintenance, compliance and improvement of the company Training program
- Report routine Quality metrics to the Senior Management team
- Maintain Document Control release, Document Control Storage Room, and electronic Quality System records
- Maintain the Training Compliance program and identify continuous improvement opportunities
- Assist with the assembly and execution of Management Review
- Help develop and deploy quality system training, including GMP, GDP, and FDA Readiness training programs
- Execute other duties and projects, as assigned by the Senior Director, Quality and/or Senior Manager, Quality Systems
| |
