Innova Medical Group, Inc. delivers better global health outcomes with its deep expertise in testing and unique offerings in diagnostic medical devices and services that help tackle some of the world’s most challenging healthcare problems. Innova specializes in innovative screening, testing and diagnostics for cancer, heart disease, arterial calcification, stroke, and virus detection focused on infectious diseases.In response to the global pandemic, Innova developed an end-to-end ecosystem of rapid diagnostic and screening tests, along with digital reporting and tracing applications to help organizations manage the COVID-19 crisis. In 2020, Innova delivered more than 220+ million COVID-19 test kits to over 20 countries around the globe, including the United Kingdom, Hungary, Singapore, United Arab Emirates, and Myanmar.As a leader in the research and development of in-vitro diagnostic reagents and test kits, Innova has improved lives with testing, monitoring, and implementing medical care. Innova Medical Group is a wholly owned subsidiary of Pasaca Capital, Inc. and is headquartered in Pasadena, CA.
The Director/Sr. Director of Quality is responsible for global product and operational compliance related to design, manufacture, sales, logistics and post-market surveillance of medical device and in-vitro diagnostic products. The position is responsible for establishing and maintaining a quality management system, providing quality assurance and quality control in keeping with business objectives.
Responsibilities (Specific tasks, duties, essential functions of the job)
- Establish and maintain an effective Quality Management System in compliance with global regulatory requirements including but not limited to ISO 13485:2016, MDSAP, National Medical Products Administration (NMPA) in China, and other international markets as determined by business objectives.
- Oversee Compliance and Ethics Program.
- Oversee all functional areas of the QMS including:
- Management Responsibility
- Internal and external audits
- Personnel Training, Qualification and Competency
- Clinical Evaluation
- Design Controls
- Risk Management
- Document and Record Controls
- Purchasing Controls
- Supplier Qualification and Management, including supplier audits
- Product Identification and Traceability
- Production and Process Controls
- Facilities, Inspection, Measuring and Test Equipment
- Process Validation
- Acceptance Activities and Acceptance Status
- Nonconforming Product
- Corrective and Preventive Action
- Packaging and Labelling
- Handling, Storage and Distribution
- Installation and Servicing
- Complaint Management
- Vigilance and Medical Device Reporting
- Field Corrective Action and Recall
- Analysis of Data and Statistical Techniques
- Design, implement and maintain a program for internal Quality System training and provision of annual GMP training.
- Manage the performance of process audits of departments to ensure compliance with Quality System, company procedures, and applicable regulations.
- Participate in product development activities, ensuring regulatory standards are understood, design control and risk management systems are in place, design validation activities are conducted, and Design History Files and Risk Management Files are maintained to support regulatory submissions.
- Ensure standardization exists between operations in all facilities. Including compliance standardization for all departments associated with the service aspect of the business
- Participate in the transfer of approved product designs into manufacturing to meet market introduction and other key milestone target dates. Ensure that Device Master Record is in place (specifications, bill of materials, drawings, material specifications, labeling, packaging, etc.). Participate in development of manufacturing, inspection/test procedures and equipment, including required validations. Establish and maintain final product release.
- Manage assigned staff and contracted consultants.
- Manage departmental activities per approved budget and annual operating plan.
- Comply with all company policies and procedures.
- Assist with any other duties as assigned.
Knowledge, Skills, and Abilities
- Must have a broad background of QMS activities in all functional areas.
- Capable of compiling data from various sources to produce useful reports and capable of trending and verifying process improvements.
- Excellent management skills, both of individuals as well as projects.
- Must have strong work ethic.
- Excellent oral and written communication skills required.
- Attention to detail is required.
- Effective conflict resolution.
- Analytical & problem-solving skills & ability to multi task.
- Solutions-oriented problem solver.
- Excellent planning, communication and organizational skills.
- Ability to effectively interface with different departments within the company.
- In-depth knowledge of global regulatory requirements, directives, and standards such as EU MDR/IVDR, ISO 13485, ISO 14971, MDSAP and NMPA programs and a track record of successfully implementing and maintaining these programs globally.
- Strong project management and organizational skills. Ability to systematically monitor, detect and improve regulatory, quality and compliance programs.
- Business acumen – able translate business strategy and objectives into a regulatory/compliance program. Able to show flexibility in approach depending on the business need.
- Strong leadership and management skills – track record of building high-performing teams. Can effectively hire talent, retain talent, set expectations, coach and top-grade the organization where appropriate.
- Bachelor’s degree in Engineering, Biological Science or related technical discipline, required.
- MBA or advanced degree in management or professional certification in manufacturing disciplines, preferred.
- 15+ years’ experience in Quality for a medical device or in-vitro diagnostic company, required.
- Direct experience in Quality Systems, Quality Assurance and Quality Control preferred.
- 8 years management experience, with a minimum of five direct reports, required.
- Advanced knowledge/proficiency in Microsoft Office, required.
All your information will be kept confidential according to EEO guidelines.
Legal authorization to work in the United States is required.
This job may be subject to a background check, consistent with State and local law, including where applicable the Los Angeles Fair Chance Ordinance, San Francisco Fair Chance Ordinance, and the California Fair Chance Act.