The Quality Engineer will assist the inspection department with; in-process, 1st piece and final inspections on complex medical device components, sub-assemblies and assemblies. The Engineer will be required to read and interpret drawings and specifications. The Engineer will be responsible for documentation requirements set forth by the company as well as ISO specifications. The Engineer will be responsible for ensuring all outside services performed on products are acceptable to the process/material as well as the documentation. The Engineer will assist the Quality Manager on projects relating to the Quality System and Regulatory requirements.
ESSENTIAL FUNCTIONS:
-Perform incoming, in-process 1st piece and final mechanical inspections.
-Perform all documentation requirements for ISO 13485 Medical Device Company
-Work with the Quality Manager to ensure all company procedures are correct and being followed
-Ensuring that product work history (DHR’s) are established and correct
-Work directly with machinists and be the quality representative on the shop floor.
-Assist the Quality Manager on related projects and Regulatory requirements.
KNOWLEDGE, SKILLS & ABILITIES:
-Knowledge of mechanical inspection methods and blue print reading
-Experience of working in an ISO/medical device environment
-A knowledge and content of the English language, including the meaning and spelling of words and rules of composition and grammar
-Active listening – Listening to what other people are saying and asking appropriate questions
-Writing – Communicating effectively with others in writing as indicated by the needs of the audience or specified requirements
-Oral Communication – The ability to communicate information and ideas to others
-Reading comprehension – Understanding written sentences and paragraphs in written documents
-Math functions – The ability to add, subtract, multiply and divide quickly and correctly
-Assist in FMEA and Validation creations
EDUCATION:
-High school graduate or equivalent
EXPERIENCE and BACKGROUND:
-The Quality Engineer should have a background of mechanical inspection in a machine shop environment
-Experience working in a medical device (ISO 13485 certified) company a plus
-Experience in machining a plus
Qualified candidates should submit resume and three professional references to Jess Grubbs at jgrubbs@aerotek.com or call 781-938-3068 with questions.
Join Aerotek CESM, one of the leading providers of engineering and engineering support professionals in North America. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across a number of different industries. We know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek CE offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek CE team! Allegis Group and its subsidiaries are equal opportunity employers.
Job Details |
Job Location |
Candidate Application |
| Employer: Aerotek CE | Address: 100 Unicorn Park Drive | Contact: Jessica L Grubbs |
| Job Type: Full-time | City: Amesbury | |
| Experience:Any | State: Massachusetts | E-mail: jgrubbs@aerotek.com |
| Education: High School / GED | Zip Code:01913 | Online: Website Link |
Rate: Based on experience.
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