Senior Quality Engineer
Company: Gateway Recruiting - Executive Recruiters
Location: Pomona
Posted on: February 19, 2021
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Job Description:
In this role, you will report to the Site Head of Quality and
actively lead QA support for the product development process and
design transfer to manufacturing, ensuring product and process
conformance to FDA Design Controls, ISO 13485:2016, ISO 14971:2012
and other applicable regulatory and technical
standards.RESPONSIBILITIES:* Lead quality assurance support in the
design and development/on market support of In-Vitro Diagnostics
(IVD) medical device products, facilitating the application of
design/change controls, risk management, quality plan and
implementation of design and development plan.* Create and maintain
risk management files such as UMFMEA/DFMEA/PFMEA that identify
Hazard Analysis Critical Control Points (HACCP) and are compliant
with the requirements of ISO 14971:2012.* Work closely with
R&D, Manufacturing, Quality Control, and Applications Support
management to prevent non-conformities and provide solutions to
complex issues.* Lead and support multiple projects, balancing
priorities and resources to meet project and management
expectations. * Review and approve proposed changes for on market
products by performing risk assessments, providing guidance and
support and assessing the adequacy of verifications and validations
and DMR documents.* Resolve QI and CAPA by performing
investigations, conducting root cause analysis, developing and
implementing plans to resolve. * Review and approve verification
and process validation, equipment qualification documents.* Lead
process improvement projects* Act as SME for key subsystems such as
Design Control, Risk Management, Design Verification, Design
Validation, Process Validation etc.* Other duties as assigned.
BASIC QUALIFICATIONS:Education and Experience Requirements:* BS/BA
in field of Science such as Chemistry, Microbiology, Biology,
Biochemistry or Engineering, OR equivalent experience.* Direct work
experience in IVD or medical device/biotech or regulated
manufacturing environment.* Minimum of 7 years of Quality Assurance
engineering experience (design controls, change control, process
validation, on market quality engineering support and risk
management) * Minimum of 7 years hands on CAPA System,
Non-conformity System, Root Cause investigation and manufacturing
process improvement experience.* Minimum of 5 years hands-on risk
management experience in creating/maintaining risk management files
such as UMFMEA/DFMEA/PFMEA, Plans, Reports, etc.* Experience
reviewing and approving Device Master Record (DMR) documents
required.* Hands on Design Verification, Design Validation/Process
Validation and Design History File (DHF) experience required.*
Knowledge of IVDR in EU, FDA QSRs, ISO 13485:2016, ISO 14971:2012
standards and HACCP/GMPGLP/GDP requirements.Preferred
Qualification:* Experience supporting new product development
desired.* Process, QMS or Supplier auditing experience desired.*
Experience with cleaning, mixing and test method validation
required.* Experience with reagent, ELISA, HEIA manufacturing
desired.* Lean Six Sigma (Black or Green Belt), Certified Quality
Engineer, Certified Quality Auditor desired.Powered by
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Keywords: Gateway Recruiting - Executive Recruiters, Pomona , Senior Quality Engineer, Engineering , Pomona, California
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