Quality Engineer II
Must Have
Job Responsibilities
·
Engineering degree with minimum 4-6 years of relevant
quality engineering experience and overall 4+ years of experience
·
Review new and modified product design documentation for
quality characteristics, including manufacturability, serviceability,
testability, reliability, and product requirements.
·
Ensure that product development projects and changes to
existing products are conducted in compliance with FDA Quality System
Regulations.
·
Participate on
cross-functional teams to review marketing requirements and to develop concise,
unambiguous, non-conflicting and feasible product requirements that support the
market needs
·
Participate with
cross-functional teams to develop product risk management file (risk management
plan, risk assessments, DFMEA, risk management report,PMS Plan & related deliverables
for EU-MDR).
·
Assist in the
creation of verification and validation plans, protocol and reports. Oversee
testing and analysis for standards and product requirements compliance.
·
Provide guidance
and direction for sample size and statistical analysis of verification and
validation test results.
·
Review Design
History Files and Technical Files for conformance to applicable requirements
·
Participate and
provide input to training on department / division procedures and policies
·
Participate when
appropriate in internal and supplier audits.
·
Provide Quality
support to facilitate resolution of product complaints and/or safety issues
·
Provide support to the Regulatory Department in
writing technical submissions.
Minimum Qualifications
·
Working knowledge of and auditing experience to the FDA Quality
System Regulation, ISO 13485, and the Medical Device Directive.
·
Good verbal and written communication skills including protocol /
report development and technical presentations.
·
Risk Management - ISO 14971
·
Process Validation (IQ, OQ, PQ), DOE, SPC and capability analysis.
·
Test plan development and root cause failure analysis.
·
Previous experience working in a cross-functional team
environment.
·
Working knowledge of and auditing experience to the FDA Quality
System Regulation, ISO
·
Stability, Biocompatibility, Sterilization, Ship Testing,
HALT/HASS.
·
Familiar with IEC 60601 and product specific industry standards.
Nice to Haves
·
ASQ CQE, CQA, CSQE and/or CRE certification.
·
13485 lnternal/Lead Auditor Certification
About
Medtronic
Together, we can change healthcare worldwide. At
Medtronic, we push the limits of what
technology, therapies and services can do to help alleviate pain, restore
health and extend life.
We challenge ourselves and each other to make tomorrow
better than yesterday. It is what makes this an exciting and rewarding place to
be.
We want to accelerate and advance our ability to
create meaningful innovations - but we will only succeed with the right people
on our team.
Let’s work together to address universal healthcare
needs and improve patients’ lives.Help us shape the future.
Whatever your specialty or ambitions, you can make a difference at Medtronic -
both in the lives of others and your career. Join us in our commitment to take
healthcare Further, Together.
