Energy Jobline ZR
Sr.Principal Quality Engineer in Wayne
Energy Jobline ZR, Wayne, Pennsylvania, United States, 19087
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We focus on the Oil & Gas, Renewables, Engineering, Power, and Nuclear markets as well as emerging technologies in EV, Battery, and Fusion. We are committed to ensuring that we offer the most exciting career opportunities from around the world for our jobseekers.
Job Title-
Principal Quality Engineer
Location-
Wayne NJ
Pay rate-
$65-70 per hour
Job Overview The Principal Quality Engineer for the Product Development/ Engineering team is responsible for ensuring the quality and compliance of designed medical devices throughout the product development lifecycle. The Principal Quality Engineer works closely with the cross‑functional product engineering team to identify and mitigate risks, implement quality controls, and ensure compliance with industry regulations and standards.
Job Responsibilities and Essential Duties
Ensures assigned product development and/or design change initiates are executed in accordance with regulations including ISO 13485, FDA 21 CFR Part 820, EU MDD, EU MDR.
Leads/Participates in the following design control related activities:
Design Planning
Risk Management
Design Verification and Validation
Design Reviews
Test Method Validation
Test Protocol /Test Report development and execution
Data analysis
Design History File maintenance
Provides Quality Engineering support for cross-functional teams
Supports failure investigations
Supports CAPA and Health Hazard Evaluations (HHE)
Minimum Requirements
A bachelor’s degree in engineering, Science, or other related field is required.
7 years’ experience in Quality or Engineering.
Experience in a medical device or pharmaceutical industry with application of Design Controls.
Experience with Class III disposable and/or Electro-Mechanical medical devices is .
Required Knowledge, Skills and Abilities
Knowledge and understanding of the US Food and Drug Administration (FDA) 21 CFR 820, ISO 13485, ISO 14971, EU MDD, and EU MDR.
Strong analytical and problem‑solving skills.
Excellent communication and interpersonal skills.
Understanding of quality tools and methodologies (e.g., Six Sigma, FMEA, Gage R&R).
Ability to work effectively in a cross‑functional team environment.
Knowledge of Microsoft Office Products such as Word, Excel, or equivalent software applications.
Environmental/Safety/Physical Work Conditions
Office and laboratory settings with occasional exposure to manufacturing environments.
Ensures environmental consciousness and safe practices are exhibited in decisions.
Use of computer, telephone equipment, measurement & test instruments, and other related office/ Laboratory accessories/devices to complete assignments.
May work extended hours during peak business cycles.
If you are interested in applying for this job please press the Apply Button and follow the application process. Energy Jobline wishes you the very best of luck in your next career move.
#J-18808-Ljbffr
We focus on the Oil & Gas, Renewables, Engineering, Power, and Nuclear markets as well as emerging technologies in EV, Battery, and Fusion. We are committed to ensuring that we offer the most exciting career opportunities from around the world for our jobseekers.
Job Title-
Principal Quality Engineer
Location-
Wayne NJ
Pay rate-
$65-70 per hour
Job Overview The Principal Quality Engineer for the Product Development/ Engineering team is responsible for ensuring the quality and compliance of designed medical devices throughout the product development lifecycle. The Principal Quality Engineer works closely with the cross‑functional product engineering team to identify and mitigate risks, implement quality controls, and ensure compliance with industry regulations and standards.
Job Responsibilities and Essential Duties
Ensures assigned product development and/or design change initiates are executed in accordance with regulations including ISO 13485, FDA 21 CFR Part 820, EU MDD, EU MDR.
Leads/Participates in the following design control related activities:
Design Planning
Risk Management
Design Verification and Validation
Design Reviews
Test Method Validation
Test Protocol /Test Report development and execution
Data analysis
Design History File maintenance
Provides Quality Engineering support for cross-functional teams
Supports failure investigations
Supports CAPA and Health Hazard Evaluations (HHE)
Minimum Requirements
A bachelor’s degree in engineering, Science, or other related field is required.
7 years’ experience in Quality or Engineering.
Experience in a medical device or pharmaceutical industry with application of Design Controls.
Experience with Class III disposable and/or Electro-Mechanical medical devices is .
Required Knowledge, Skills and Abilities
Knowledge and understanding of the US Food and Drug Administration (FDA) 21 CFR 820, ISO 13485, ISO 14971, EU MDD, and EU MDR.
Strong analytical and problem‑solving skills.
Excellent communication and interpersonal skills.
Understanding of quality tools and methodologies (e.g., Six Sigma, FMEA, Gage R&R).
Ability to work effectively in a cross‑functional team environment.
Knowledge of Microsoft Office Products such as Word, Excel, or equivalent software applications.
Environmental/Safety/Physical Work Conditions
Office and laboratory settings with occasional exposure to manufacturing environments.
Ensures environmental consciousness and safe practices are exhibited in decisions.
Use of computer, telephone equipment, measurement & test instruments, and other related office/ Laboratory accessories/devices to complete assignments.
May work extended hours during peak business cycles.
If you are interested in applying for this job please press the Apply Button and follow the application process. Energy Jobline wishes you the very best of luck in your next career move.
#J-18808-Ljbffr