We are seeking a motivated individual with a working knowledge of Quality Systems to lead, establish, implement and maintain quality assurance systems and activities ensuring compliance with domestic and international quality system standards and regulations for research and medical devices developed by CPSI. The individual will also provide technical and organizational leadership to Quality / Quality Assurance activities and expand the Quality Assurance function by providing value-added services to the company. The individual must be a strategic thinker, good communicator and possess the ability to inspire and lead others. The individual must be able to work in a flexible R&D based technology development small business environment. The Quality Manager will work side by side extensively with engineering and life sciences employees as well as outside Quality consultants and report directly to the Director of Operations and CEO.
Specific Responsibilities include:
- Serve as the development liaison with consulting firm to develop and implement a Quality Management System (QMS) to ensure the company’s products are in compliance with quality standards and applicable regulations.
- Administer and maintain the Quality Management System and once implemented.
- Responsible for the strategy, administration, and direction of the Quality Assurance organization.
- Directs all aspects of Quality Assurance, using a well-grounded understanding of technical, scientific and regulatory issues.
- Monitor the Quality Management System
- Interact with Contract Manufacturer to assure QMS compliance of production activities
- Member of the QMTeam, with responsibility for assigning and monitoring all CAPA activities.
- Functions as an integral member of new product development teams. Responsible for ensuring compliance during the design control and design transfer processes.
- Provide guidance to product development and research team members to ensure development activities are performed in a phase appropriate manner, compliant with Company and regulatory expectations
- Participates in new product development team meetings, technical design reviews, and phase gate design review meetings to contribute quality assurance requirements and considerations.
- Review and approve, as required, documents that support design control including but not limited to drawings, part numbers, specifications, control strategy documents, stability protocols, plans, and reports
- Leads risk management activities throughout the product lifecycle, including new product development and post production risk management.
- Regularly reviews quality system standard operating procedures and work instructions, making changes as necessary to ensure compliance and efficiency Quality Assurance processes.
- Provides input to the Management Review and Quality Review Board processes.
- Responds to nonconformities identified in internal audits, and to corrective / preventive actions assigned to Quality Assurance.
- Responsible for responses to inspections, audit and regulatory responses.
- Maintenance of support of the QMS through internal audits, development of procedures, maintenance of quality records and training of office and manufacturing personnel.
- Responsible for all aspects of regulatory compliance including FDA regulations.
- Assemble and maintain documentation
Qualifications and Education Requirements
1 year+ experience experience in a quality assurance / quality systems field (ideally in the medical device industry)
- Ability to execute work on multiple projects simultaneously a must
- Strong experience and familiarity with product development and outsourced contract manufacturing of products that are highly regulated by the government.
- Demonstrated knowledge and understanding of the 21CFR Part 820 and ISO 14971:2012 requirements.
- Implement and maintain a quality management system in accordance with FDA standards
- Ability to provide leadership to others in the organization through influence, innovative practices and coaching skills to foster a corporate culture that of responsiveness, compliance awareness, self-regulation, quality system ownership, challenge of status quo, and continuous improvement in order to achieve the highest level of compliance.
- Excellent written and verbal communication skills. Strong organizational skills. Excellent problem solving methodology, using industry accepted concepts and tools to solve complex problems in creative and effective ways as they apply to compliance issues.
- Possesses a technical background, sufficient to establish credibility with senior management as well as the product development teams.
- Hands-on ability to sort through technical complexities and work in a flexible changing environment
- Able to work in a team and in a high intensity small company environment
- Ability to work varied and extended hours/days, as business dictates.
- Strong planning, organizing, and communications skills.
- Ability to manage a large volume of information at once, keeping focused on priorities.
- Conscientious, detail orientated character
- Analytical mind set and enjoy working with data and statistical information
- Strong attention to detail with excellent follow-up
- Strong analytical judgment
- Dynamic, detail oriented, organized and effective
- Excellent team player
Benefits Package includes Medical, Dental, Life Insurance, 401k, Paid Time Off
Join CPSI Biotech and help us bring our innovative medical devices to the next stage!