Quality Engineer (Electronics) - Seraph Biosciences, Inc - Detroit
Exciting new opportunity for a quality engineer in the biotech space with a hot, growing Detroit-based company.
About the company:
Seraph Biosciences was created specifically to commercialize Seraspec®, a Raman spectroscopy-based platform technology for real time pathogen detection and identification at the point of care. Seraspec® represents a paradigm shift away from existing methods for identification of dangerous bacterial, viral, fungal and parasitic infections. Our patent pending technology and method of detection effectively eliminates the need for costly and time-consuming laboratory-based methods of specimen collection, processing and pathogen identification.
About the Role:
In this role, you will:
- Actively participate in product development cycle by reviewing mechanical, electrical and software project documentation, participating in product risk assessments, and working closely with Product Development to develop appropriate verification and validation testing requirements.
- Assess overall product risk by facilitating the development of risk management tools such as the risk management report, failure mode and effects analyses (FMEAs), etc.
- Collect, analyze and interpret statistical data. Perform analyses and provide reports to management as required.
- Prepare procedures, protocols and test reports in support of establishing a quality system.
- Monitor supplier performance and initiate corrective actions (CAPA), as required. Be involved in the creation/monitoring of supplier quality agreements.
- Work with contract manufacturers to ensure compliance with QSR and GMP’s.
- Track timelines and facilitate required Quality Engineering deliverables.
- Assist with projects and assure creation and consistent implementation of best practice quality engineering tools.
- Provide support to other quality groups (both internal and external to Seraph Biosciences) to ensure efficient completion of project requirements.
- Identify and implement software process metrics for the software product development life cycle.
- Develop, analyze, and monitor metrics which pertain to software defects uncovered during development, testing, and post-release.
- Provide solutions to a wide range of difficult challenges. Work independently to determine and develop solutions that are imaginative, thorough, practicable, and consistent with organizational objectives.
- Travel may be required up to 20%.
- Bachelor's degree in engineering, math, physical science, or equivalent field
- Capacity to collaborate on a daily basis with a wide variety of engineers, physicists, programmers, lab technicians, and management teams
- Strong analysis and problem-solving skills
Seraph Biosciences, Inc. is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Seraph Biosciences, Inc. also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.
Please send your resume to Info@AmyCellTalent.com - thanks!