Overview
On Site
USD 35.00 - 45.00 per hour
Full Time
Skills
Sustainability
SAFE
Research and Development
Regulatory Affairs
Design Controls
Inspection
Testing
Evaluation
Design Review
Risk Analysis
Test Methods
Process Improvement
Manufacturing
Leadership
Product Development
Regulatory Compliance
Training
Quality Assurance
Continuous Improvement
Mechanical Engineering
Electrical Engineering
Materials Science
Biomedical Engineering
Data Collection
Data Analysis
Scientific Research
Risk Management
Corrective And Preventive Action
Auditing
Statistics
Medical Devices
ISO 13485
GDP
GMP
Six Sigma
Privacy
Marketing
Job Details
Location: Guadalupe, AZ
Salary: $35.00 USD Hourly - $45.00 USD Hourly
Description: Our client is currently seeking a Senior Engineer, Quality Assurance Engineering for a 12 month + contract.
Seeking a Senior Engineer, Advanced Quality for our Sustainability Solutions team supporting our reprocessing product line. You will be a key member of the new product development team ensuring the implementation of cutting-edge technology for medical devices is safe, effective, and compliant with industry practices. Working closely with R&D, Marketing, Advanced Operations, and Regulatory Affairs team members, you will be in a fast-paced environment with opportunities to win for yourself, the company, and patients around the world. This position is a hybrid between a traditional R&D Engineer and a traditional Quality Engineer.
Workplace Flexibility: Candidate must reside within a commutable distance to Tempe, AZ and is expected to be onsite 3+ days/week at the facility and is not eligible to be fully remote.
What you will do:
Represents Quality Assurance on New Product Development (NPD) cross-functional teams, collaborating with R&D, Regulatory Affairs, Advanced Operations, and Marketing to meet product development metrics.
Leads Risk Management activities, including creating and implementing Risk Management Files, identifying hazards, and ensuring compliance with corporate and divisional design control procedures.
Plans, designs, and implements inspection, testing, and evaluation methods to ensure product and production reliability, applying advanced statistical techniques for test sample size determinations.
Leads Design Reviews to ensure design and process robustness, compliance with applicable regulations (e.g., QSR, ISO 13485), and proper risk analysis for new medical devices.
Plans, performs, and reviews engineering risk analyses, test methods, and process improvements to enhance product quality and manufacturing efficiency.
Provides leadership in product development by guiding engineering principles, interpreting test data, and developing process and product protocols.
Mentors junior staff, leads departmental initiatives, and influences multiple teams to drive quality and regulatory compliance throughout the development process.
May interact with customers to address product quality concerns, provide training on quality assurance and GMP topics, and support continuous improvement initiatives.
What you will need: Required:
Bachelor's degree in Mechanical, Electrical, Chemical, Material Science, and/or Biomedical Engineering. Minimum of 2+ years' experience in an engineering role.
Experience in data collection, data analysis, and scientific method. Preferred:
Experience with Quality Concepts such as Risk Management, CAPA, Audits, Statistics.
Previous medical device industry experience preferred
Understanding of US and International Medical Device Regulations, including ISO 13485, GDP, GMP.
Six Sigma Green Belt or ASQ CQE.
Candidate must reside within a commutable distance to Tempe, AZ and is expected to be onsite 3+ days/week at the facility and is not eligible to be fully remote.
By providing your phone number, you consent to: (1) receive automated text messages and calls from the Judge Group, Inc. and its affiliates (collectively "Judge") to such phone number regarding job opportunities, your job application, and for other related purposes. Message & data rates apply and message frequency may vary. Consistent with Judge's Privacy Policy, information obtained from your consent will not be shared with third parties for marketing/promotional purposes. Reply STOP to opt out of receiving telephone calls and text messages from Judge and HELP for help.
Contact:
This job and many more are available through The Judge Group. Please apply with us today!
Salary: $35.00 USD Hourly - $45.00 USD Hourly
Description: Our client is currently seeking a Senior Engineer, Quality Assurance Engineering for a 12 month + contract.
Seeking a Senior Engineer, Advanced Quality for our Sustainability Solutions team supporting our reprocessing product line. You will be a key member of the new product development team ensuring the implementation of cutting-edge technology for medical devices is safe, effective, and compliant with industry practices. Working closely with R&D, Marketing, Advanced Operations, and Regulatory Affairs team members, you will be in a fast-paced environment with opportunities to win for yourself, the company, and patients around the world. This position is a hybrid between a traditional R&D Engineer and a traditional Quality Engineer.
Workplace Flexibility: Candidate must reside within a commutable distance to Tempe, AZ and is expected to be onsite 3+ days/week at the facility and is not eligible to be fully remote.
What you will do:
Represents Quality Assurance on New Product Development (NPD) cross-functional teams, collaborating with R&D, Regulatory Affairs, Advanced Operations, and Marketing to meet product development metrics.
Leads Risk Management activities, including creating and implementing Risk Management Files, identifying hazards, and ensuring compliance with corporate and divisional design control procedures.
Plans, designs, and implements inspection, testing, and evaluation methods to ensure product and production reliability, applying advanced statistical techniques for test sample size determinations.
Leads Design Reviews to ensure design and process robustness, compliance with applicable regulations (e.g., QSR, ISO 13485), and proper risk analysis for new medical devices.
Plans, performs, and reviews engineering risk analyses, test methods, and process improvements to enhance product quality and manufacturing efficiency.
Provides leadership in product development by guiding engineering principles, interpreting test data, and developing process and product protocols.
Mentors junior staff, leads departmental initiatives, and influences multiple teams to drive quality and regulatory compliance throughout the development process.
May interact with customers to address product quality concerns, provide training on quality assurance and GMP topics, and support continuous improvement initiatives.
What you will need: Required:
Bachelor's degree in Mechanical, Electrical, Chemical, Material Science, and/or Biomedical Engineering. Minimum of 2+ years' experience in an engineering role.
Experience in data collection, data analysis, and scientific method. Preferred:
Experience with Quality Concepts such as Risk Management, CAPA, Audits, Statistics.
Previous medical device industry experience preferred
Understanding of US and International Medical Device Regulations, including ISO 13485, GDP, GMP.
Six Sigma Green Belt or ASQ CQE.
Candidate must reside within a commutable distance to Tempe, AZ and is expected to be onsite 3+ days/week at the facility and is not eligible to be fully remote.
By providing your phone number, you consent to: (1) receive automated text messages and calls from the Judge Group, Inc. and its affiliates (collectively "Judge") to such phone number regarding job opportunities, your job application, and for other related purposes. Message & data rates apply and message frequency may vary. Consistent with Judge's Privacy Policy, information obtained from your consent will not be shared with third parties for marketing/promotional purposes. Reply STOP to opt out of receiving telephone calls and text messages from Judge and HELP for help.
Contact:
This job and many more are available through The Judge Group. Please apply with us today!
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.