Overview
On Site
BASED ON EXPERIENCE
Contract - W2
Contract - Independent
Skills
DESIGN QUALITY
DESIGN QA
DESIGN ASSURANCE
QUALITY ASSURANCE
QA
QUALITY CONTROL
DESIGN CONTROL
DESIGN CONTROLS
DESIGN CHANGES
DESIGN HISTORY FILE
DESIGN HISTORY FILES
DHF
DESIGN INPUT
DESIGN OUTPUT
RISK MANAGEMENT
FMEA
HAZARD ANALYSIS
DESIGN VERIFICATION
DESIGN VALIDATION
VERIFICATION AND VALIDATION
V and V
MEDICAL DEVICE COMPANY
MEDICAL DEVICE COMPANIES
BOSTON SCIENTIFIC
MEDTRONIC
BIOTECH
MEDICAL DEVICES
MEDICAL DEVICE
THERMO FISHER
HOLOGIC
SIEMENS
PERKINELMER
HAEMONETICS
COVIDIEN
MERCK
PFIZER
JOHNSON AND JOHNSON
J and J
MEDTRONIC
STRYKER CORPORATION
BOSTON SCIENTIFIC
ABBOTT LABORATORIES
ZIMMER BIOMET
3M HEALTH CARE
THERMO FISHER SCIENTIFIC
EDWARDS LIFESCIENCES
BAXTER INTERNATIONAL
GE HEALTHCARE
PHILIPS HEALTHCARE
DANAHER CORPORATION
VARIAN MEDICAL SYSTEMS
CARDINAL HEALTH
ILLUMINA
INC.
DENTSPLY SIRONA
ALIGN TECHNOLOGY
HILL-ROM HOLDINGS
SIEMENS HEALTHINEERS
BD BECTON
DICKINSON AND COMPANY
SMITH and NEPHEW
HOLOGIC
INC.
RESMED
BAUSCH HEALTH
EXACT SCIENCES
ABIOMED
TELEFLEX INCORPORATED
INTEGRA LIFESCIENCES
ORASURE TECHNOLOGIES
GLOBUS MEDICAL
CANTEL MEDICAL CORP
CONVATEC
DRAEGER MEDICAL SYSTEMS
CAGENT VASCULAR
B. BRAUN MEDICAL INC.
JOHNSON and JOHNSON
Job Details
Quality Engineer III
Qualifications:
If this job is a match for your background, we would be honored to receive your application!
Job Summary: Talent Software Services is in search of a Quality Engineer for a contract position in Maple Grove, MN. The opportunity will be one year with a strong chance for a long-term extension.
Position Summary:
The Design Quality Engineer will support the application of design controls to projects focusing on design changes, material continuity, regulatory and standards compliance, corrective and preventive actions, and improvements for manufacturability and cost reduction. This individual will work with a cross-functional team to ensure safety, quality, and compliance of products.Primary Responsibilities/Accountabilities:
- Ownership of design change projects including scoping, assessment, and implementation.
- Develop, update, and maintain Design History File and Design Input / Output documentation
- Develop, update and maintain risk management files, such as the Hazard Analysis, Task Analysis, and Design FMEA.
- Develop and execute Design Verification, Design Validation, and Usability protocols and reports to meet or exceed internal and external requirements.
- Provide design quality support in the resolution of PIRs, CAPAs, and NCEPs.
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Imaging diagnostic catheter design changes
- Working with a team of 5 Design Assurance engineers
- Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
Qualifications:
- Bachelor's degree in an engineering discipline
- Experience in design assurance, quality, or related medical device or regulated industry experience
- 5 - 7 Years experience with BS, 3 - 5 Years with MS
- Medical device experience preferred
- Must have worked in a regulated space
- Design quality experience
- Design assurance experience
- Risk management experience
- Good problem-solving ability
If this job is a match for your background, we would be honored to receive your application!
Providing consulting opportunities to TALENTed people since 1987, we offer a host of opportunities, including contract, contract to hire, and permanent placement. Let's talk!
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