Quality Engineer - Med Device
Company: Michael Page
Location: Durham
Posted on: January 15, 2021
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Job Description:
MPI does not discriminate on the basis of race, color, religion,
sex, sexual orientation, gender identity or expression, national
origin, age, disability, veteran status, marital status, or based
on an individual's status in any group or class protected by
applicable federal, state or local law. MPI encourages applications
from minorities, women, the disabled, protected veterans and all
other qualified applicants.SummaryLead product and process
improvements by collecting, compiling, reporting and analyzing
data. Drive continuous improvement projects relating to both
engineering and product development activities..Client
DetailsConfidential manufacturing company - medical device and
pharmaDescription* Plan, coordinate and own quality subsystems such
as design control, risk management, design verification, design
validation, process validation, etc.* Perform design review
inspections, design control reviews, and other quality and
regulatory associated activities, working closely with an
engineering team of various disciplines and technical aptitudes*
Documentation, technical writing and reporting of quality
engineering functions for FDA forms, submissions, approvals and
trackingProfile* Minimum 5 years of quality or regulatory
compliance experience in the medical device and/or pharmaceutical
industries (other regulated industries may be considered).* Or
equivalent combination of education and experience.* Previous use
of Reliance electronic quality management system or equivalent.*
Quality System Auditor / Lead Auditor certification desired.Job
OfferSalary, 401k match, Vacation, PTO, health insurance, and
benefitsJob Requirements:Plan, coordinate and own quality
subsystems such as design control, risk management, design
verification, design validation, process validation, etc. Perform
design review inspections, design control reviews, and other
quality and regulatory associated activities, working closely with
an engineering team of various disciplines and technical aptitudes
Documentation, technical writing and reporting of quality
engineering functions for FDA forms, submissions, approvals and
trackingSDL2017
Keywords: Michael Page, Durham , Quality Engineer - Med Device, Other , Durham, North Carolina
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