Principal Quality Engineer
Company: AbbVie
Location: Irvine
Posted on: August 4, 2022
|
|
Job Description:
We are open to the Principal Quality Engineer working remote or
hybrid approach, however based out of Southern California. Job
Description The Principal QE is part of AbbVie's Third-Party Device
Quality group, based in Irvine, CA, and reports to the Director,
Medical Device Quality (or equivalent). The role oversees product
quality assurance (PQA) for commercial medical devices which are
manufactured by third parties. As such, the Principal QE works
closely with AbbVie's Contract Manufacturing Organizations (CMOs),
relevant third-party suppliers (e.g., custom components), and
internal stakeholders to ensure compliance with defined
specifications and regulatory requirements. The position supports
Quality Management System activities, including - but not limited
to - routine product release, CAPAs/NCRs, Change Control,
Complaints, Product Release, Supplier Quality Agreements, etc. The
Principal QE provides strong technical leadership in the TPQ
Quality function amongst peers, ensuring that functional activities
are compliant and aligned with overall company goals and
strategies. Duties & Responsibilities Work with CMOs and/or
third-party suppliers to assure timely and compliant release of
commercial product and/or components in accordance with defined
specifications and processes Work with CMOs and/or third-party
suppliers to ensure that non-conformances, CAPAs, Reworks, and
deviations are accurately documented, reviewed, and approved Work
with CMOs and/or third-party suppliers to resolve compliance issues
related to commercial product and/or custom components Review and
approve changes to supplier processes which impact device and/or
component manufacture Review and approve technical protocols,
reports, and specifications, as appropriate Support the development
of and updates to third party device Risk Management Files Champion
development and maintenance of KPIs and trend analysis at supplier
site, as applicable Escalate issues to Quality leadership, as
appropriate Support Device Analysis Lab activities, including
evaluation of returned devices and DHR review, as appropriate
Support Quality Systems group during Regulatory inspections (i.e.,
serve as product SME) Support Supplier Audit function during CMO
site audits Develop and maintain effective cross-functional
relationships Minimum Qualifications Degree in engineering,
physical, or life sciences with direct experience working in a
regulated environment: Bachelor's Degree: 10 years' experience
Master's Degree: 7 years' experience Doctoral Degree: 3 years'
experience Experience working with medical device suppliers Working
knowledge of medical device regulations (e.g., 21 CFR 820, ISO
13485, EU MDR 2017/745, etc.) Working knowledge of Statistical
Process Controls (SPCs) Working knowledge of Acceptance Sampling
(AQL, RQL) and related tools (e.g., ANSI/ASQ Z1.4, Z1.9, etc.)
Basic understanding of Design-of-Experiments (DOE) Experience in
cGMPs Experience reviewing and approving production drawings, batch
history records/DHRs, and other documentation Experience working
with equipment qualifications or process validations The ability to
recognize problems and take corrective measures Strong attention to
detail Organized, with strong multitasking abilities Ability to
work collaboratively and independently Fluent in verbal and written
English Preferred Qualifications ASQ Certification (CQA, CQE, CRE)
or international equivalent Six-sigma certification Working
knowledge of design control requirements (21 CFR 820.30) Physical
Job Requirements This position primarily works in an office
environment (85%), however it may also include time in a laboratory
and/or at an external plant - both which may require standing and
manual labor. Travel time is less than 20%. When submitting your
resume, please include a writing samplewhich describes how you've
used Quality tools to solve a problem, and/or describes your
approach to continuous improvement (2-4
paragraphs).PDN-ABV2201869
Keywords: AbbVie, Irvine , Principal Quality Engineer, Engineering , Irvine, California
Click
here to apply!
|