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Quality Engineer Manufacturing - Danbury, United States - Mastech Digital
Description
Job DescriptionJob DescriptionTITLE :
Quality Engineer
II
LOCATION:
Danbury CT (
SHIFT HOURS:
8-5 /
Mostly onsite
with the ability to work remote 1 day/week)
DURATION:
6 months + extension/or conversion to PERM
Interview Process: 1st Round virtual, 2nd round
ONSITE
Responsibilities :
of raw materials, materials in process, and finished products.
Requires a bachelor's degree
and 0-2 years of experience in the field or in a related area.
SUMMARY
Designs, implements and maintains quality assurance protocols and methods for processing materials into partially finished or finished products.
Responsible for planning, implementing and managing compliance of manufacturing and production processes with internal and external safety, quality and regulatory standards requirements for worldwide distribution.
Designs methods and procedures for inspecting, testing and evaluating the precision and accuracy of production processes, production equipment and finished products.
Performs analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary.
May assure compliance to in-house and/or external specifications and standards (i.e. GLP, GMP, ISO, Six Sigma).
Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
Developing professional expertise, applies company policies and procedures to resolve a variety of issues. Normally receives general instructions on routine work, detailed instructions on new projects or assignments.
Responsibilities
(Technical Field Preferred), May have Master's Degree
Experience
Skills
o Excellent computer skills including ability to use
word processing, spreadsheet programs and databases
o Excellent ability to read,
analyze and interpret professional journals, technical procedures
and government regulations.
o
Excellent technical writing skills with ability to write quality assurance reports
and details procedures
o Good presentation skills
o Good interpersonal skills to interact with all levels of the company, sometimes in an adversary role
o
Knowledge of GMP and GDP Principles
Beneficial
o Working
knowledge of medical device Quality System Regulations (21CFR820), ISO 13485 and MDD
requirements
o Knowledge of
microbiology, molecular biology, biochemistry, chemistry and/or related disciplines
o Understanding of nucleic acid amplification and detection technologies
o Understanding of Scientific Method and statistical analysis
o Knowledge of
Oracle
and
Agile
o Experience in an
FDA regulated industry
o
Certified
Quality Engineer
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