Junior Quality Engineer
Junior Quality Engineer
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1 Vacancy
Job Description
How you will make an impact as a Junior Quality Engineer:
- Work cooperatively with other team members and in compliance with applicable standards and regulations such as 21 CFR 820 and ISO 13485:2016
- Evaluate project and design compliance to applicable standards and regulations
- Use critical thinking and analysis to determine the best approach and provide guidance on QMS compliance to design team members
- Support development of complex electromechanical devices including software through quality system processes
- Participate in Risk Management activities in accordance with ISO 14971:2019 such as FMEAs and Risk Analysis
- Assist in the development implementationand approval of Device Master Records and Device History Records
- Participate in investigations resulting in root cause and corrective actions through use of data analysis inductive and deductive reasoning and problem solving skills
- Coordinate the efforts of individuals and teams performing investigations
- Ensure the accurate documentation and recording of information to be used in communication with partners and regulatory bodies
- Support system and process improvements using six sigma tools
- Support reliability and statistical analysis
- Support in internal and external audits
- Bachelors degree in Biomedical Mechanical Electrical ora related engineering discipline
- Ability to work as part of a multidisciplinary team
- Excellent verbal and written communication skills as well asattention to detail
- Ability to understand and provide guidance on quality system procedures
- 1 years of experience in any suitable occupation related to quality control of medical devices preferred
- Completion of Capstone CoOp or Internship project in the medical device field preferred
- Experience with medical devices and Risk Analysis and Design Transfer preferred
- Experience with compliance to applicable standards and regulations such as 21 CFR 820 and ISO 13485:2016 preferred
About DEKA:
One hour from the beach Boston and the mountains the historic Amoskeag Millyard once housed the largest textile mills in the world. It is now home to DEKA Research & Development where we are taking the same innovation and cuttingedge technology into the modern age.
Behind DEKAs brick walls sits a team of professionals who strive to make a difference every day through thoughtful engineering design and manufacturing. Here at DEKA some of the most innovative and lifechanging products of our time are created and new ideas are always welcome and explored.
Required Experience:
Junior IC
Employment Type
Full-Time
