Position: Director of Quality
Reports to: CFO
Position Location: Company HQ in Suburban Philadelphia, PA
The Director of Quality is responsible for ensuring that the development, performance and quality of products and services conform to established company, international and governmental regulatory standards, agency guidelines, and customer requirements by implementing and maintaining quality assurance policies, processes, procedures, and controls.
- Lead managing and improving the Quality Management System
- Plan and oversee the development and maintenance of quality plans and procedures and coordinate with internal departments to ensure satisfactory quality system and product performance.
- Perform the quality system roles of Document Coordinator, Training Coordinator, Complaint Coordinator, and CAPA/Investigation Coordinator.
- Partner with Product Development to draft and implement product design control principles and documentation.
- Develop, collect, and analyze data and information from a variety of sources. Perform functions such as data preparation, analyses and reporting.
- Coordinate corrective action plans, procedures, and milestone schedules. Perform/Assist investigations including root cause analysis and corrective action facilitation.
- Provide process expertise to company employees, suppliers, customers, and regulatory agencies to ensure compliance with company, client, and regulatory requirements.
- Assist in providing consistent quality of production by auditing good manufacturing practice (GMP) systems, and validating processes (internal or external as required).
- Lead the creation and maintenance of product and design history files
- Manage controlled documentation for all phases of development
- Participate in product development gate reviews
- Manage supplier quality controls
- Lead internal audits for process conformity
- Organize, lead and represent MOBILion during external audits of all company processes and practices as required
Required Skills & Qualifications:
- Bachelor's degree in the sciences or related field preferred. Combination of education and relevant experience in lieu of bachelor's degree may be considered
- Strong Understanding of quality system principles and requirements per ISO 9001:2015
- Ability to recommend template improvements for quality relevant documentation
- Strong understanding of QMS development and continuous improvement
- Ability to improve the quality management system as it applies to products based on complex systems
Preferred Skills & Qualifications:
- Expertise with MS SharePoint, Team Collaboration Software Tools
- Industry experience with medical device quality management systems and requirements per CFR Title 21, Part 820, ISO 13485, and ISO 14971
- Lean Six Sigma Black Belt Certification
- Senior Leadership Team
- Product Development (HW / SW)
- Manufacturing and Supply Chain
- Commercial Operations
- Product Manager
- Business Development
- Applications Development
- Supply Chain Partners
- MOBIE HRIM–MS Product Customers
- QMS Certification Consultants and Bodies
- Quality Associations and Organizations
Cultural, Behavioral and General Characteristics
- Work standards/high work ethic – initiative and drive
- Innovativeness & creativity
- Self-sufficient, self-driven, self-motivated (work with minimal supervision)
- Ability to think through complex issues and solve problems.
- Desire to share information and support a transparent culture.