Quality Systems Manager
VitalConnect is delivering a revolutionary solution for in hospital and outpatient care to address the growing need for patient data connectivity. VitalConnect leverages extensive expertise in biomedical engineering, data analytics, chip design, and mobile and cloud software to create technology that supports decision-making paradigms that achieve better health and economic outcomes. VitalConnect’s products are designed for use in a broad range of inpatient and outpatient settings, such as hospital monitoring, post-discharge care, cardiac monitoring and pharmaceutical solutions.
The Quality Systems Manager will be responsible for the day-to-day management and execution of the Quality System within the organization. This hands-on position will actively maintain all aspects of the Quality System to ensure compliance with the regulatory and regional requirements applicable to VitalConnect. The position will directly interface with Operations and R&D.
- Manage the implementation, maintenance, and improvement of Quality Systems based on established direction and priorities
- Ensuring VitalConnect’s regulatory compliance to FDA Quality System Regulations, ISO 13485, MDR, and other applicable regulatory standards
- Responsible for reviewing internal documentation to ensure compliance to VitalConnect’s processes and policies
- Lead, support, and perform activities in the following areas: Complaints, Supplier Management, CAPA, Nonconformance Investigations, Quality Management Reviews, Risk Management, Post Market Surveillance, and Quality Metrics
- Compile and report key performance indicators, metrics and compliance status of Quality Systems for Management Review
- Prepare materials for management review, including meeting minutes and following up on action items to ensure they are completed
- Provide quality review and authorship for standard operating procedures and quality review of design history file documentation and design reviews
- Provides direction to ensure adequate support is provided to Operations for the development, modification and qualification of manufactured components
- Drive compliance of the supply chain through supplier audit, process control, and inspection
- Actively participate during audits by competent authority, regulatory agencies, and corporate partners.
- Assigned as back-up Management Representative
- Provide exceptional customer service to internal and external customers in all assigned tasks and foster a compliance culture
- Assist with Training on quality-related topics
- Perform root-cause analysis and other problem solving activities to identify effective corrective actions and process improvements
- B.S. or higher degree
- 10 years’ experience in the medical device industry
- Strong documentation skills
- Ability to influence team members with diverse technical backgrounds
- 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.
- Strong organizational skills and excellent attention to detail and follow-through
- Risk adverse where needed with the ability to identify potential solutions to complex problems
Benefits at VCI include:
- Employee Medical, Dental, and Vision benefits paid 100% by Vital Connect for employee and dependents!
- Pre IPO Stock
- Annual holiday shutdown from Christmas to New Years!
- Lunch catered daily (TOGO's, Premier Pizza, Subway, Gotta Eatta Pitta, Rangoli India, Panda Express, BBQ, and many more!)
- Morning snacks provided (Hi5 Fruit, Whole Foods, Noah's Bagels, Hobee's)
- Free on-site gym