Overview
On Site
Accepts corp to corp applications
Contract - Independent
Contract - W2
Contract - long term
Skills
Skype
Technical Support
Product Development
Surveillance
Product Design
Engineering Design
Change Control
Supplier Relationship Management
Design Controls
Document Review
Documentation
Research and Development
NPI
Verification And Validation
Good Manufacturing Practice
Manufacturing
Regulatory Compliance
Training
Quality Improvement
Reporting
Risk Management
Collaboration
Auditing
Science
Quality Assurance
Pharmaceutical Industry
Electromechanics
Functional Requirements
Pharmaceutics
Technical Writing
Problem Solving
Conflict Resolution
NCR
Corrective And Preventive Action
Microsoft Word
Microsoft Excel
Microsoft PowerPoint
Microsoft Visio
Adobe
Quality Management
Firmware
System Integration
ISO 13485
Medical Devices
Effective Communication
Management
Supervision
Oracle UCM
SANS
OM
WebKit
IMG
Job Details
Senior Quality Engineer(Onsite)
Location:Franksville, WI
Interview:Phone+Skype
Job Description:
A Brief Overview
This position is responsible for providing Quality Engineering and Technical Support for Operations, Sustaining Engineering, R&D, and New Product Introductions. This position would include supporting a wide array of activities related to Change Control, NCR/CAPA, Quality Operations, Design Control, New Product Development, Risk Management and Post Market Surveillance. This position would evaluate the operation of Manufacturing and Quality activities in relation to compliance to Quality Standards and Regulations and recommend where corrections or improvements are needed. Provide direct support to Quality personnel regarding operation of the department and Quality System. Provide support to other departmental activities as directed.
What You Will Do
Change Control: Review change requests and identify impact on product design and documentation Support Change Control Activities (Operations, Engineering, Design, etc.). Support updates to manufacturing procedures, process, product / specifications, risk management files, etc. through the Change Control process. Support 3rd party supplier management activities such as review 3rd party design control activities.
Design Control/Documentation: Review documentation for technical accuracy and compliance to procedures Review Technical Writing and Documentation Support operations, sustaining engineer, R&D and NPI departments in the development, verification and validation of product changes and introduction of new products.
Quality initiatives: Provide quality engineering support for supplier changes and resolution of issues at suppliers. Identifies new quality improvement initiatives / projects in accordance with cGMP expectations to improve compliance, quality levels (reducing defects), and improve operational efficiencies Works with manufacturing and other functional groups on manufacturing regulatory compliance issue Support training program by delivering assigned training tasks.
Support NCR and CAPA: Support / lead corrective/preventive actions and product non-conformances including capturing data and investigations associated with product deviations, product non-conformances, CAPAs, scrap and rework, and analyzing the data for the reasons of Quality Improvement and reporting.
Risk Management: Support Risk Management activities including review and coordination of quality activities related to risk.
Inspections: Support with federal, state, and local regulatory officials during regulatory inspections Support in internal and vendor quality system audits as applicable.
Adherence to regulations: Assist with adherence to all Federal, State and Local Regulations controlling the manufacture of Electromechanical Devices (EMD) and non-EMD medical devices.
Other duties as assigned: Provides support to Quality Management personnel and perform other duties as assigned.
Minimum Requirements
Bachelor of Science (B.S.) Physical Science or Engineering, or equivalent experience.
3-5 years Quality Engineering Role.
6-7 years Medical Device or Pharmaceutical Industry or similar experience.
Preferred Qualifications
Working with electromechanical devices.
ASQ Certification as a Quality Engineer or equivalent.
Technical & Functional Skills
Knowledge of quality requirements for medical device / pharmaceutical organization.
Strong technical writing skills.
Ability to analyze product changes and identify their impact.
Strong technical and general problem-solving skills required; experience with NCR/CAPA processes.
Computer skills in Microsoft Word, Excel, PowerPoint, Visio; Adobe; and Quality System Management Software.
Understanding of system software, firmware, and hardware integration.
Familiarity with statistical sampling requirements for Design Verification and Process Validation.
Familiar with ISO 13485 Quality System Standards, FDA Quality System Regulations, GMPs, and/or other international medical device regulations.
Highly effective communication skills. Ability to work with company staff and communicate effectively throughout the organization.
Manage multiple priorities and work with interruptions.
Ability to work with minimal supervision and to make effective decisions for issues of a diverse and complex scope when required.
What You Will Do
Change Control: Review change requests and identify impact on product design and documentation Support Change Control Activities (Operations, Engineering, Design, etc.). Support updates to manufacturing procedures, process, product / specifications, risk management files, etc. through the Change Control process. Support 3rd party supplier management activities such as review 3rd party design control activities.
Design Control/Documentation: Review documentation for technical accuracy and compliance to procedures Review Technical Writing and Documentation Support operations, sustaining engineer, R&D and NPI departments in the development, verification and validation of product changes and introduction of new products.
Quality initiatives: Provide quality engineering support for supplier changes and resolution of issues at suppliers. Identifies new quality improvement initiatives / projects in accordance with cGMP expectations to improve compliance, quality levels (reducing defects), and improve operational efficiencies Works with manufacturing and other functional groups on manufacturing regulatory compliance issue Support training program by delivering assigned training tasks.
Support NCR and CAPA: Support / lead corrective/preventive actions and product non-conformances including capturing data and investigations associated with product deviations, product non-conformances, CAPAs, scrap and rework, and analyzing the data for the reasons of Quality Improvement and reporting.
Risk Management: Support Risk Management activities including review and coordination of quality activities related to risk.
Inspections: Support with federal, state, and local regulatory officials during regulatory inspections Support in internal and vendor quality system audits as applicable.
Adherence to regulations: Assist with adherence to all Federal, State and Local Regulations controlling the manufacture of Electromechanical Devices (EMD) and non-EMD medical devices.
Other duties as assigned: Provides support to Quality Management personnel and perform other duties as assigned.
Minimum Requirements
Bachelor of Science (B.S.) Physical Science or Engineering, or equivalent experience.
3-5 years Quality Engineering Role.
6-7 years Medical Device or Pharmaceutical Industry or similar experience.
Preferred Qualifications
Working with electromechanical devices.
ASQ Certification as a Quality Engineer or equivalent.
Technical & Functional Skills
Knowledge of quality requirements for medical device / pharmaceutical organization.
Strong technical writing skills.
Ability to analyze product changes and identify their impact.
Strong technical and general problem-solving skills required; experience with NCR/CAPA processes.
Computer skills in Microsoft Word, Excel, PowerPoint, Visio; Adobe; and Quality System Management Software.
Understanding of system software, firmware, and hardware integration.
Familiarity with statistical sampling requirements for Design Verification and Process Validation.
Familiar with ISO 13485 Quality System Standards, FDA Quality System Regulations, GMPs, and/or other international medical device regulations.
Highly effective communication skills. Ability to work with company staff and communicate effectively throughout the organization.
Manage multiple priorities and work with interruptions.
Ability to work with minimal supervision and to make effective decisions for issues of a diverse and complex scope when required.
Himanshu Goswami
Sr. IT Technical Recruiter
Stellent IT Phone:
Email: Himanshu.goswami
Gtalk: Himanshu.goswamiom
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