Quality Engineer
Company: US Tech Solutions
Location: San Diego
Posted on: May 26, 2023
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Job Description:
Duration: 9-10+ months(with possible extension) --- 3 Must haves
on the resume: Risk Management Knowledge, Design controls exposure,
Knowledge with Engineering change control processes, targeted
knowledge with MDR Responsibilities: --- Support modification and
maintenance of quality system procedures for the design center that
comply with ISO 13485:2016 and 21 CFR 820 requirements ---
Implement Corporate and Business level Quality System procedures
for the design center locations under supervision --- Facilitate
internal quality system audits per the procedural requirements ---
Support the management of external audits --- Lead or Support the
development of content for the management review process --- Update
and report on monthly quality metrics --- Provide inputs on
revisions to Corporate and Business level procedures as necessary
--- Support supplier management efforts for the design center ---
Maintain outsourcing relationships with internal customers and
suppliers by management of quality agreements Scope of
Responsibilities: ---Work is performed without appreciable
direction ---Wetermine and pursue course of action necessary to
obtain desired results Educational Requirements: --- A minimum of
Bachelor's degree in Science or related discipline --- Certified
ISO 9001/13485 Lead auditor is desirable --- Knowledge of Design
Control, Risk Management and QMS processes --- Minimum 1-2 years of
experience developing and sustaining quality systems of medical
devices Knowledge and Skills: --- Exposed to internal and external
audits as an auditor and/ or auditee --- Some knowledge of
applicable regulatory and industry standards (21 CFR 820, ISO
13485, MDD, MDR, ISO 14971, etc.) --- Good technical writing,
communication skills, and managing small quality system project ---
Desirable knowledge with Design Control/ Change control process,
CAPA, Deviations and Non-conformances --- Design Control --- EU
MOD/MOR --- Change control --- Risk Management --- Process
Validation --- Identification of CTQ's --- Handling of deviations
and non-conformances --- Test method validations CAPA- Root cause
investigation and implementation of corrective / preventive actions
--- Proper Use of Statistics (Sampling Plans) --- Advise on
Regulations and standards --- Liaise with Manufacturing Plants ---
Provide functional support to cross-functional teams G Support
Internal and external audits Requirements: Bachelor's Degree A
minimum of 9 years of relevant experience or a combination of
equivalent education and relevant experience Minimum 2 - 3 years of
experience supporting design assurance for medical devices
Extensive knowledge of applicable regulatory, Corporate and/or Unit
requirements. Applicable Regulatory and Industry standards
(21-CFR-820, ISO '13485, MOD, MOR, ISO 14971,ISO 10993, etc.)
Knowledge and Skills: Quality Engineering tools, Statistics,
Problem Solving, strong Interpersonal Skills, Leadership, all forms
of Communication ASQ Certificate(s) desirable (but not required)
About US Tech Solutions: US Tech Solutions is a global staff
augmentation firm providing a wide range of talent on-demand and
total workforce solutions. To know more about US Tech Solutions,
please visit .
Keywords: US Tech Solutions, San Diego , Quality Engineer, Engineering , San Diego, California
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