Quality Engineer - Regulatory AffairsQuality Engineer - Regulatory Affairs
Job ID Quality
Engineer - Regulatory Affairs
410-1208 Length of Engagement: Direct Hire
No visa sponsorship Position Description: The Quality Engineer uses Quality
Engineering principles, tools and techniques to develop, review
and/or optimize systems and processes so that they are aligned
with the overall Company strategy and mission effecting continuous
quality improvement. Coordinates or performs testing to verify
equipment and processes comply with current procedures, and appropriate
regulations and standards (i.e., QSR, ISO-13485, AAMI, ANSI,
ETC.). Develops and maintains all associated documentation. Assists
in process and product improvement projects and provides technical
input and assistance, helps ensure Company is compliant with
regulatory requirements and quality assurance tasks with regard
to the development of new products/processes for reprocessing
as well as the continued maintenance of current process validations.
Coordinate activities with appropriate Departments to ensure
validation testing is in line with regulatory requirements and
manufacturing needs. Responsibilities:
* Assists in researching device
usage and device regulatory requirements to determine viability
of reprocessing for new products;
* Creates and implements validation
protocols, testing protocols and executes and/or aids in the
execution of cleaning, sterilization, packaging and performance
testing of new & existing products and processes;
* Develops and uses tools such
as process flow charts, failure modes effects analysis (FMEA),
control plans, validation plans, to quote and communicate validation
requirements to the project team.
* Reviews/analyzes data &
documentation, Supports, consults, trains and leads quality improvement
projects throughout the life cycle of products, including product
design and development, manufacturing, and purchasing.
* Utilizes Quality Engineering
tools and techniques to establish sampling plans, develop quality
plans, conduct and participates in Risk Management activities,
supports engineering activities, conducts process and systems
audits, develops specifications.
* Analyzes routine and test data
for improvement opportunities. Designs and implements experiments
(DOE''s) for process and product improvement and validation testing
* Evaluates manufacturing quality
performance capability and develops criteria to monitor and improves
* Investigate instances of nonconforming
material and facilitate the determination of root cause, corrective
action/preventive action and recommendation of disposition for
the material review board.
* Develop personal performance
objectives based upon company quality objectives, reporting monthly
on progress made against those goals.
* Has a working knowledge of the
Quality System Regulation (21 CFR PART 820) as well as ISO 13485
and ISO 14971 requirements.
Required Skills, Knowledge
* Minimum 2 yrs experience and/or
training or equivalent combination of education and experience.
* Experience in medical device
* Current certification of Certified
Quality Engineer (CQE) or demonstrated ability to effectively
use this core knowledge is preferred.
* Excellent technical writing
skills, including ability to write speeches, procedures, and
articles for publication conforming to prescribed style
* Strong organizational skills
* Must have strong analytical/critical
* Ability to define problems,
collect data, establish facts and draw valid conclusions.
* Must be detail-oriented and
thorough in all tasks
* Strong profiency in MS Word,
Excel, Outlook; able to learn new programs quickly
* BS (Engineering, Life Sciences,
Preferred Skills, Knowledge
* Certified Quality Engineer (CQE)
* Career Readiness Certification
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