ABOUT OUR COMPANY
At InBios, we believe an accurate diagnosis is the first step to effective treatment. Specializing in the design, development and manufacture of immunodiagnostic devices for infectious diseases, InBios International Inc. strives to improve health outcomes globally by providing superior quality products that are accurate, easy to use and cost effective. Founded in 1996 in Seattle, WA, InBios has 70+ employees and more than 25 products, including FDA-cleared ELISA kits for Zika, dengue and West Nile as well as rapid test kits for Chagas and leishmaniasis. Most recently, we responded to the coronavirus crisis, receiving FDA EUAs for three COVID-19 products while continuing to develop other tests to fight this pandemic. InBios also specializes in the development and manufacture of highly specific and well-characterized antibodies and antigens for use in infectious disease research.
To achieve our mission of providing top-quality diagnostics for diseases that affect millions around the world, InBios has a diverse, well trained and highly educated group of dedicated employees. The entrepreneurial spirit that led to our founding is still prevalent in our culture, where we encourage employees at all levels to contribute to and collaborate on new ideas and products. We value risk-takers and problem-solvers, and pride ourselves on offering opportunities for both personal and professional growth.
Located in the dynamic South Lake Union neighborhood of Seattle in a state-of-the-art biotech facility, InBios offers competitive wages and a rich benefit package that includes medical, dental and vision insurance, 401(k), and performance-based rewards. InBios is committed to work/life balance and provides paid vacation and sick time, including a weeklong, paid shutdown in December.
We are seeking a mindful and diligent individual with a warm and welcoming attitude who has excellent organizational and communication skills and a keen eye for detail. If you enjoy a busy workday, analytical work, leading and collaborating on projects, and being part of a reliable and dedicated Quality Assurance team, then we encourage you to apply for this position.
Experience and knowledge needed to be successful in this position
BS or BA with 5+ years experience or MS with 3+ years experience working in a FDA regulated industry.
Experience leading CAPA and Deviation Management to closure.
Demonstrated knowledge of quality engineering medical device regulations, supplier quality control, design control and risk management.
Prior experience conducting internal and supplier audits.
Experience with and working knowledge of cGMP, ISO 13485:2016, and GLP quality systems, policies and regulations/guidelines.
Knowledge of international regulatory standards.
Ability to lead and coordinate cross-functional projects.
Exceptional analytical and problem-solving skills with the proven ability to think strategically.
Strong written and verbal communication skills.
Excellent knowledge of MS Word and Excel. Experience with databases and electronic documentation systems is a plus.
ASQ certifications in ISO 13485.
Strong understanding of statistical analysis and six sigma methodology.
Thesis-based MS Degree in engineering or life sciences.
Prior experience manufacturing or validating ELISA, lateral flow, and/or real-time PCR assays.
What are your job responsibilities?
Primary duties will include:
Oversee, coordinate and review tracking of Deviations, Change Controls, CAPAs.
Conduct root cause failure analyses and corrective actions.
Review and approve batch records, device history records, deviations, change controls, corrective and preventive actions (CAPA) and specifications.
Identify product failure modes and provide possible solutions through product quality and process improvements.
Lead review of quality records and set up DMRs and DHRs.
Prepare, maintain and analyze metrics related to the quality systems.
Lead staff trainings to ensure continued adherence to cGMP.
Coordinate and conduct internal audits and supplier audits.
Work with R&D and manufacturing to ensure effective design transfer.
Provide input to cross-functional teams to ensure Design Controls are understood and applied.
Conduct process evaluations and validations utilizing tools such as SPC, DOE and capability studies.
Participate/lead risk management activities including FMEAs.
Work environment information
Position responsibilities include work in a Biosafety Level 2 lab (BSL-2.)
Posting ID: 564542475Posted: 2020-08-07