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PharmBio Product Quality Engineer Job
Date: Jul 25, 2010
Location: Elkton, MD, US
PharmBio Product Quality Engineer-100067
Description
Gore is a technology-driven global company built on entrepreneurial innovation, integrity, and teamwork. Through our product leadership, we've been changing lives and changing industries including medical devices, fabrics, electronics, and manufacturing for more than 50 years.
We are seeking a Quality Engineer to join the Bioprocess Solutions Business Unit in our Industrial Products Division. In an organization dedicated to manufacturing products that are the highest quality, Quality Engineering at Gore is the place to be!
If you are searching for a company where you can make a difference, we're looking for you. Within this role you will have the opportunity to impact the quality of existing products during manufacturing as well as next-generation products during new product design and development.
The ideal candidate will
* Be passionate about manufacturing products that are the highest quality in their class
* Be energized by working in a hands-on, world-class manufacturing facility collaborating with Quality Assurance associates, process engineers, and new product development teams
* Recognize the importance of building and maintaining strong interpersonal relationships
In the role of Quality Engineer, you will be responsible for
* Performing root cause analyses on product non-conformances, including product issues resulting from customer complaints, and driving resolution through engineering studies and corrective actions
* Supporting elements of new product development by helping to drive the process development and documentation through validation
* Developing and implementing specifications for raw materials, components, and products
* Developing and validating test methods for product safety, efficacy, and fitness for use
* Risk management
More specifically, you will
* Perform and write validations of products, processes, and equipment in accordance with Food and Drug Administration (FDA) and International Standards Organization (ISO) guidelines
* Design, execute, and analyze experiments based on statistical techniques
* Write procedures, train other associates, and assist other technical associates
* Evaluate proposed improvements to processes and products based on analyses of regulatory requirements, product quality needs, ergonomics, safety, environmental, and economics
* Design and test prototypes
* Document work via reports, technology notebooks, and design file entries
Qualifications
Required:
* A Bachelors' degree in Science or Engineering; ChE, ME, Materials or Polymer Science, or an advanced technical degree preferred
* 7 + years engineering experience; previous hands on experience in process, quality or complex new product development preferred
* Strong project management skills, including demonstrated ability to prioritize, initiate, and drive projects to completion
* Solid knowledge of engineering fundamentals, including statistics, and the ability to apply this knowledge to manufacturing and product design
* An ability to use experimental design, fundamentals of probability, and statistical process control tools to assure reliability, process maintainability, and product safety
* Strong problem-solving skills
* An ability to lead teams by networking and interfacing effectively with a broad range of associates spanning varied disciplines and responsibilities
* Demonstrated excellent communication skills, both written and oral, including presentation skills
* A working understanding of, or the willingness to learn, Quality System Regulations (QSRs) for appropriate Current Good Manufacturing Practices (cGMP) [21CFR 820, 21CFR 211, 21CFR 600 (including design control and risk management)] ISO 13485, and ISO 9000 requirements
* Demonstrated ability to document thoroughly
* Ability to work effectively in the Quality System
* Willingness to travel up to 15%
Desirable
* Background in biochemistry
* Previous hands-on experience with medical component manufacturing and/or product manufacturing
EEO/AA Employer (applies to all positions located in the U.S.)
Job
: Engineer/Scientist
Primary Location
: North America-United States-Maryland-Elkton
Travel
: Yes, 15% of the time
Shift
: Day (1st shift)
Description
Gore is a technology-driven global company built on entrepreneurial innovation, integrity, and teamwork. Through our product leadership, we've been changing lives and changing industries including medical devices, fabrics, electronics, and manufacturing for more than 50 years.
We are seeking a Quality Engineer to join the Bioprocess Solutions Business Unit in our Industrial Products Division. In an organization dedicated to manufacturing products that are the highest quality, Quality Engineering at Gore is the place to be!
If you are searching for a company where you can make a difference, we're looking for you. Within this role you will have the opportunity to impact the quality of existing products during manufacturing as well as next-generation products during new product design and development.
The ideal candidate will
* Be passionate about manufacturing products that are the highest quality in their class
* Be energized by working in a hands-on, world-class manufacturing facility collaborating with Quality Assurance associates, process engineers, and new product development teams
* Recognize the importance of building and maintaining strong interpersonal relationships
In the role of Quality Engineer, you will be responsible for
* Performing root cause analyses on product non-conformances, including product issues resulting from customer complaints, and driving resolution through engineering studies and corrective actions
* Supporting elements of new product development by helping to drive the process development and documentation through validation
* Developing and implementing specifications for raw materials, components, and products
* Developing and validating test methods for product safety, efficacy, and fitness for use
* Risk management
More specifically, you will
* Perform and write validations of products, processes, and equipment in accordance with Food and Drug Administration (FDA) and International Standards Organization (ISO) guidelines
* Design, execute, and analyze experiments based on statistical techniques
* Write procedures, train other associates, and assist other technical associates
* Evaluate proposed improvements to processes and products based on analyses of regulatory requirements, product quality needs, ergonomics, safety, environmental, and economics
* Design and test prototypes
* Document work via reports, technology notebooks, and design file entries
Qualifications
Required:
* A Bachelors' degree in Science or Engineering; ChE, ME, Materials or Polymer Science, or an advanced technical degree preferred
* 7 + years engineering experience; previous hands on experience in process, quality or complex new product development preferred
* Strong project management skills, including demonstrated ability to prioritize, initiate, and drive projects to completion
* Solid knowledge of engineering fundamentals, including statistics, and the ability to apply this knowledge to manufacturing and product design
* An ability to use experimental design, fundamentals of probability, and statistical process control tools to assure reliability, process maintainability, and product safety
* Strong problem-solving skills
* An ability to lead teams by networking and interfacing effectively with a broad range of associates spanning varied disciplines and responsibilities
* Demonstrated excellent communication skills, both written and oral, including presentation skills
* A working understanding of, or the willingness to learn, Quality System Regulations (QSRs) for appropriate Current Good Manufacturing Practices (cGMP) [21CFR 820, 21CFR 211, 21CFR 600 (including design control and risk management)] ISO 13485, and ISO 9000 requirements
* Demonstrated ability to document thoroughly
* Ability to work effectively in the Quality System
* Willingness to travel up to 15%
Desirable
* Background in biochemistry
* Previous hands-on experience with medical component manufacturing and/or product manufacturing
EEO/AA Employer (applies to all positions located in the U.S.)
Job
: Engineer/Scientist
Primary Location
: North America-United States-Maryland-Elkton
Travel
: Yes, 15% of the time
Shift
: Day (1st shift)
Nearest Major Market: Philadelphia
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