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Senior Quality Engineer

SeLux Diagnostics Inc
SeLux Diagnostics Inc
Job Functions:
Other Engineering
Employment Types:
Boston, MA, USA
100,000 – 115,000 USD per year
Posted on:
bout Selux Diagnostics “Antibiotic resistance is putting the achievements of modern medicine at risk.” - World Health Organization Selux’s mission is to preserve the lifesaving efficacy of antibiotics and transform infectious disease patient care by providing diagnostic results within hours rather than days. At Selux, we are building a multidimensional team of talented individuals to help achieve this mission. Our company was recently awarded FDA “Breakthrough Device Designation” which is reserved only for devices that “provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human diseases.” The customers and patients we serve have diverse life experiences and so do we. Selux is focused on hiring talented people from a wide range of backgrounds and providing a safe work environment where everyone feels that they belong. Vaccination is a requirement of employment. Subject to applicable law Please apply now and come join us in this critical mission! Learn more at Duties and Responsibilities  Support the development of Quality infrastructure by working with management on the development and enhancement of critical processes and procedures, as well as training and mentoring less experienced auditing staff Function as primary liaison for third-party design and development partners providing support for development activities, resolve quality issues, ensure appropriate flow down of quality requirements, and enable positive channels of communication. Generate, review, and implement Quality related policy/procedure/ and guideline development Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function at cross functional technical meetings and Reviews) Provide guidance for engineer, software, scientific departments on Medical Device regulations Work with Supply Chain as needed and provide assistance to develop corrective actions Applies knowledge of design control principles, statistics, process & systems validation, and quality engineering techniques to positively influence projects and manufacturing. Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Performs other duties as required Qualifications Must Haves Bachelor’s degree in an engineering or science related field Minimum of 5 years’ experience in a Medical Device field Working knowledge of the Quality System Regulation (FDA 21 CFR Part 820) Nice to Have Knowledge of Medical Device Software regulations and implementation Previous work in a commercial program Experience working with suppliers and/or contract manufacturers Skills/Competencies Ability to work effectively within team and across functions Effective verbal and written communication skills Knowledge of basic statistical and quality control principals Travel <20%