Kephera Diagnostics is an early-stage company aiming to address the public health challenges of global infectious diseases with point of care assay technology. Our mission is to promote more effective and affordable medical treatment through faster, point-of-care diagnosis. We collaborate with a global community of researchers to develop and translate new technologies into accessible products for clinical diagnostics and research applications. Kephera has recently been funded for development of new tests for several infectious diseases of global significance.
Kephera seeks a motivated, entrepreneurial individual for the position of Quality Assurance Manager, to be responsible for QA for the company’s operations and CLIA laboratory.
The QA Manager will have the support of a Quality Consultant as needed and will be an integral contributor to the development, implementation, and maintenance of ISO 13485, 21CFR820, and CLIA compliant quality systems. The specialist will also facilitate the creation and submission of regulatory filings for the company’s medical diagnostics products.
Responsibilities:
- Participate in the development of a quality management system, including document control.
- Identify and fill Quality System gaps with compliant but efficient SOPs.
- Manage QA processes, including document control, supplier quality, audits, and training.
- Oversee quality activities related to GMP materials, production, laboratory, facilities, and equipment.
- Review documentation related to GMP manufacturing and CLIA testing.
- Ensure compliance with documented policies and procedures.
- Support the authoring and submission of regulatory filings.
- Support regulatory inspections.
- Support the organization as needed.
Qualifications:
Primary skills and knowledge required include, but are not limited to the following:
- 2-5 years QA, manufacturing, and/or laboratory experience in In-vitro Diagnostics, medical devices, biotech, or CLIA laboratory.
- Working knowledge of 21 CFR 820 QSR, ISO 13485, and/or CLIA regulations.
- Experience supporting regulatory filings (e.g., 510k and Technical Files).
- Experience developing and maintaining a document control system.
- Ability to work independently in an extremely fast-paced, dynamic environment.
- Self-motivated with a desire to expand QMS knowledge and experience.
- Must be a team player with good interpersonal skills.
- Excellent problem-solving, organization and communication skills.
- Bachelor’s degree or higher.
- Proficiency in Microsoft Office Suite.
Kephera offers a dynamic start-up environment combining flexibility, challenging work, and the opportunity to participate in a new venture aimed at improving global public health. Kephera’s location in downtown Framingham offers free parking and commuter rail accessibility. Kephera is committed to a diverse workplace.
Job Type: Full-time. Partial remote work option.
