Tech Evaluation Login
Tech Evaluation Signup
PasswordReset
Unsubscribe
PasswordReset
PasswordReset
PasswordReset
Register for Webinar
Register for Event
Job Channels
Skill Score
About Us
Contact Us
Our Blog
Toggle navigation
Home
Skill Score
DemandIndex
Jobs
FETCH Jobs
Java J2EE
Dot Net, C#
DBA
SAP
Admin, Networking
Datawarehousing
QA
Demo
Candidate
Recruiter
Services
Job Posting & Resume Access
Integrated Talent Sourcing
Sub Contractor Supply Chain
Merger & Acquisition
Candidate
Post Resume
Login
Create Job Alert
Recruiter
Login
Free Trial
Signup
Pricing
| Pricing
Dashboard
My Resumes
Resume List
Add Resume
Edit / Update Resume
My Jobs
Fetch Jobs
Matched Jobs
Applied Jobs
AU86235_QA Tester with Validation Testing(FDA) at Irvine CA
Irvine, CA
Irvine
CA
92710
Date
: Jul-25-17
2017-07-25
2018-07-25
AU86235_QA Tester with Validation Testing(FDA) at Irvine CA
Irvine, CA
Jul-25-17
Work Authorization
US Citizen
GC
H1B
GC EAD
Preferred Employment
Corp-Corp
W2-Permanent
W2-Contract
1099-Contract
Contract to Hire
Job Details
Experience
:
Senior
Rate/Salary ($)
:
DOE
Duration
:
6 Months
Sp. Area
:
QA, Testing Automation
Sp. Skills
:
x-Other
Permanent Direct Hire
Consulting / Contract
FULL_TIME, CONTRACTOR
Direct Client Requirement
Required Skills
:
Key Words: Quality Engineering + Medical Device + FDA + design control + Validation + statistics
Preferred Skills
:
Key Words: Quality Engineering + Medical Device + FDA + design control + Validation + statistics
Domain
:
Pharmaceuticals, Manufacturing
Work Authorization
US Citizen
GC
GC EAD
H1B
Preferred Employment
Corp-Corp
W2-Permanent
W2-Contract
1099-Contract
Contract to Hire
Job Details
Experience
:
Senior
Rate/Salary ($)
:
DOE
Duration
:
6 Months
Sp. Area
:
QA, Testing Automation
Sp. Skills
:
x-Other
Permanent Direct Hire
Consulting / Contract
FULL_TIME, CONTRACTOR
Direct Client Requirement
Required Skills
:
Key Words: Quality Engineering + Medical Device + FDA + design control + Validation + statistics
Preferred Skills
:
Key Words: Quality Engineering + Medical Device + FDA + design control + Validation + statistics
Domain
:
Pharmaceuticals, Manufacturing
resource-logistics.com
Iselin, NJ
Post Resume to
View Contact Details &
Apply for Job
Job Description
:
Role: QA Tester with Validation Testing(FDA)
Location: Irvine CA
Duration: 6+ Months
Quality Engineer with experience in Medical industry to responsible to lead DHF gap assessment & remediation activities
Specific Search Key Words :
Key Words: Quality Engineering + Medical Device + FDA + design control + Validation + statistics
Primary
· Actively represent Quality Assurance function on product/process project teams.
Provide guidance to Engineering staff and other personnel and ensures that design control requirements are being met in an effective manner, including those for design verification, validation, specification and procedure development, risk management, and design review.
Lead the investigation of complex product problems. Identify and manage corrective actions resulting from problem investigations.
Lead or participate in design reviews to evaluate designs and to help identify alternative design solutions.
Develops master test plans that encompass design verification, design validation and process validation activities.
Test Method and Process Validation remediation including approaches and methodologies for validation
Project Management skills to ensure project has required resources and meeting project timeline.
Evaluates test protocols and reports to ensure that the testing is sufficient to meet regulatory requirements and quality objectives.
Provides input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested.
Analyzes and investigates returned clinical investigation products to determine the cause for return.
Contributes to design input requirements from experience with previously reported problems competitive devices and/or other similar products.
Promotes continuous improvement in design control activities and use of quality tools with design team.
Participates in supplier selection process and specification reviews with suppliers to ensure that purchased items meet Medtronic specifications.
Specifies quality characteristics and inspection plans for components, subassemblies, and finished devices.
Evaluates and dispositions nonconforming materials and products used in pilot and clinical builds, to arrive at the most economical disposition, while meeting all quality system requirements.
Comply with applicable FDA and international regulatory laws/standards
Maintain knowledge of current regulatory requirements and standards as they pertain to the development and release of medical devices.
Secondary:
· Experience in vascular devices, embolic coils, stents, catheters, balloons, aspiration devices, coatings and/or guide wires.
Self-motivated and committed to a team approach
Strong interpersonal, organizational and project management skills
Strong oral, presentation and technical writing skills
Demonstrated skills in decision making – preferably across a broad spectrum of Quality Engineering responsibilities
Certified Quality Engineer (CQE) / Certified Biomedical Auditor (CBA) preferred
Client :
Resource Logistics Inc.
Turn OFF keyword highlights
Similar Jobs you may be interested in ..
Remote - SAP BTP Integration Consultant
,
Santa Ana, CA
Mar-21-24
Intone Networks
($) :
USD 100 / Hourly / C
Role: SAP BTP Integration Consultant Location: Role is onsite based out of Santa Ana, CA, hybrid 3 days in office End Client: Yokohoma Tire Corp Job Description: Job Requirements: 8 to 10 years of overall SAP experience. Must have at least 2+ years of design and development experience in SAP BTP Workflow Management Service. Must be familiar with design and development principles of custom workflows using SAP BTP Workflow Management Service. Must be familiar with User Tasks, Scri
Apply
[Apply Individually]
Remote -
QA
Engineer
,
Los Angeles, CA
Mar-07-24
Technogen, Inc
($) :
USD 69
Role: Sr.
QA
Engineer (ETL Testing) Duration: 6 months (likely to extend) Location: Los Angeles, CA (Remote) Qualifications: At least 8+ years as a Software Quality Assurance Engineer role including functional and non-functional testing activities. Experience participating in the review of business requirements to develop test strategy, deploy risk-based testing tactics, writing test plans and test cases. Experience as an Author of automated scripts according to Software Quality Assu
Apply
[Apply Individually]
Interoperability Architect
,
Lake Forest, CA
Mar-08-24
tanishasystems
($) :
$60k - $130k/year
Title Interoperability Architect (481166) Location Lake Forest, CA (REMOTE) Tech stack: Java MS, Java Spring boot, AWS Cloud computing, cyber security Key Responsibilities: System Design and Integration: Develop frameworks for integrating various medical devices (SiMD/SAMD) this including hardware, software, and cloud technologies; Ensure seamless connectivity and interoperability of medical technologies, mobile apps, and digital health platforms. Standards Complian
Apply
[Apply Individually]
Flutter Consultant
,
Aliso Viejo, CA
Mar-07-24
tanishasystems
($) :
$60k - $130k/year
Title: Flutter ConsultantLocation: 21930 SE 51st Street, Issaquah, WA-98029 (Onsite/Need local Only)Duration: Full Time Job Description:Must Have Skills Flutter LeadSkill 1 10+ Years of Experience in FlutterSkill 2 15+ years of Experience developing mobile apps natively in iOSSkill 3 8+ Years of Experience in Dart, Flutter, iOS, Git, WebpackSkill 4 5+ Years of Experience -Java, Spring Boot, Microservices, API Development Designing, developing, testing, maintaining, and deploying soft
Apply
[Apply Individually]
Business Solutions Analyst
,
Alhambra, CA
Mar-29-24
wati
($) :
$60k - $130k/year
Job Title: Business Solutions Analyst California- Onsite Duration: 12 Months Position Description A Business Solutions Analyst performs business systems analysis and is responsible for work that involves applying analytical processes to the planning, design and implementation of new and improved business information systems and business processes to meet the business requirements of customer organizations. The Business Solutions Analyst will perform needs analyses to define opportunities
Apply
[Apply Individually]
Labview Developer
,
Irvine, CA
Mar-04-24
UNICOM Technologies Inc
($) :
$60K-140K/ Year
Role: Labview DeveloperLocation: Irvine, CADuration: 6 months +US Citizen / GCWe are looking for a LabView Developer who can work along with our Manufacturing customer's team to develop new modules for Testing and Production related software engineering requirement. Features typically include equipment's data logging, monitoring and control. Required to discuss with cross-functional team including Engineers, Product Designers, Production and Quality. Looking for hands-on experience in developmen
Apply
[Already Applied]
[Apply Individually]
Azure Date Architect
,
Los Angeles, CA
Mar-29-24
wati
($) :
$60k - $130k/year
Job Title: Azure Date Architect Location: Los Angeles, CA, 90012 Duration: 12 Months Client: LA County JCOD-Justice Care and Opportunity Dept Position Description A Technical Architect will serve as the manager of complex technology implementations, with an eye toward constant reengineering and refactoring to ensure the simplest and most elegant system possible to accomplish the desired need; understand how to maximize leverage of the open source community to deploy systems on Infrastructure
Apply
[Apply Individually]
DevOps Infrastructure Engineer
,
Downey, CA
Mar-29-24
wati
($) :
$60k - $130k/year
Job Title: Linux System Administrator Location: Downey, CA, 90242 Duration: 12 Months Client: LA County ISD SSB Job Description The Linux System Administrator is responsible for applying Red Hat Enterprise Linux (RHEL), Ubuntu, CentOS, Suse and Debian concepts and industry best practices to resolve complex issues, provide daily operational management of private and public cloud Linux server instances, maintaining thorough documentation of procedures and system configurations, selecting method
Apply
[Apply Individually]
Remote - DevOps Infrastructure Engineer
,
Downey, CA
Mar-10-24
wati
($) :
$60k - $130k/year
Job Title: Linux System Administrator Location: Downey, CA, 90242 Duration: 12 Months Client: LA County ISD SSB Job Description The Linux System Administrator is responsible for applying Red Hat Enterprise Linux (RHEL), Ubuntu, CentOS, Suse and Debian concepts and industry best practices to resolve complex issues, provide daily operational management of private and public cloud Linux server instances, maintaining thorough documentation of procedures and system configurations, selecting method
Apply
[Apply Individually]
McAfee Consultant
,
Downey, CA
Mar-29-24
wati
($) :
$60k - $130k/year
Job Title: McAfee Consultant Location: Remote, Downey, CA Duration: 12 months Skills Required Security Engineers will possess knowledge and experience in safeguarding sensitive data from cyber-attacks. Skills Preferred Possess knowledge of all McAfee/MVision products such as native encryption, FRP, HIPS, DLP, Move, TIE, ATD, ATP, ENS, Firewall, Web Control, Application Control and VSE engines, native drive encryption, drive and removable media encryption etc. Architect, deploy, and support McA
Apply
[Apply Individually]