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Title: Quality Assurance Engineer
Hiring Organization: Connexion Systems & Engineering
Compensation, Benefits, and Employment Type
- Duration – Contract – 4 months++
- Pay rate: $40-50/hr.
- Job Location: Danbury, CT
- Job#: bh12623
Quality Assurance Engineer
The Quality Assurance Engineer provides medical device Quality Assurance technical expertise by participating in the day-to-day operation of the Department as it relates to the design and manufacture of medical devices. The Quality Engineer would work on a range of quality initiatives with regards to the management and improvement of the product, process and supplier quality. Responsible for ensuring that the products produced meet applicable regulatory and quality standards and customer expectations. Responsible for identifying and raising quality issues and for speedily resolving them to ensure zero impact to the customer. Support new product introductions to ensure the robustness of product builds. Work in a team environment to develop and implement best practices that emphasize defect prevention, reduction in variation and waste and provide for continuous improvements in meeting all customer requirements.
Essential Duties and Responsibilities
The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
- Provides Quality Engineering support to existing products
- Supports Quality Control with technical input on inspection documentation and with the Material Review Board (MRB)
- Review’s product-related change orders, engineering studies and sustaining engineering projects to assure high quality products and adherence to Quality System requirements.
- Interfaces with Post-Market Quality to review and act upon trended data from complaint investigations and manufacturing metrics.
- Provides Quality System support to assure compliance with current Medical Device Quality - System Regulation and Medical Device Directive requirements:
- Reviews/approves specifications, drawings, manufacturing procedures
- Aids in the development of Inspection Procedures and Test Methods
- Reviews/approves design verification and validation documentation
- Supports Risk Management activities
- Develops Product Quality Plans
- Coordinates risk assessments and updates Risk Management documentation as required
- Assists Quality at external manufacturing sites on root cause investigations and corrective actions.
- Very good working knowledge of medical device Quality System Regulations (21CFR820), ISO 13485 and MDD requirements.
- Computer literate: able to use word processing, spreadsheet programs, databases.
- Excellent ability to read, analyze and interpret professional journals, technical procedures and government regulations.
- Excellent writing skills with ability to write quality assurance reports and detailed procedures.
- Good presentation skills.
- Good interpersonal skills to interact with all levels of the company.
- Bachelor's degree (BA or BS) in a technical discipline. Preferably Electrical Engineering.
- 5+ years related experience in an FDA regulated industry or equivalent combination of education and experience.
- Certified Quality Engineer desirable.
Experience with sterilization and cleanroom processes preferred.
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