Senior Advanced Quality Engineer Job in Warwick, RI 02887
Title :
Senior Advanced Quality Engineer
Company :
C. R. Bard
Location :
Warwick, RI 02887
Date Acquired :
2/18/2010 1:26:06 AM
Senior Advanced Quality Engineer
/Category:, Job ID:, Standard Title:, Career Level:, Location/Division:, Relocation:, Posted Date:, Close Date:">
Industry Title
/Category: Medical Device/Quality Assurance
Job ID: 2010-4169
Standard Title: Senior Advanced Quality Engineer
Career Level: experienced
Location/Division: Warwick, RI/Davol
Relocation: Yes
Posted Date: 3/5/2010
Close Date: ..
C. R. Bard, Inc. (NYSE: BCR)is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 11,000 people in over 25 countries around the world. Founded more than 100 years ago, we pioneered many devices that are now the cornerstones of modern healthcare.
We expect the highest levels of quality, integrity, service, and innovation from our employees on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded.
Be Your Best at Bard and ultimately, you can have an impact on the lives of people around the world.
Apply for this position
* Refer a friend to this job
More information about this job:
Overview:
The position of the Sr. Advanced Quality Engineer is responsible to assure that new product designs and the processes for manufacturing them meet all Corporate and Divisional requirements with respect to safety and efficacy. This individual will represent quality interests and concerns on project teams and report to the Manager of Advanced Quality Engineering.
Essential Job Functions:
* Provide technical guidance to Quality Engineers, Quality Technicians, and Inspectors.
* Lead Quality Engineering Projects to improve Quality Systems and Procedures.
* Development of Test Protocols and Final Reports to support Regulatory 510K or PMA submissions.
* Development of the DFMEA, coordinating input from the other Design Sub-team members.
* Development of the Design Verification Protocol and the subsequent Design Verification Report
* Provide input into the project Design Input Summary (DIS), Product Performance Specification (PPS), Product Development Plan (PDP), and applicable design control documents as defined per Davol’s product development process
* Determine the degree of Biocompatibility testing required as per ISO10993 and company procedures.
* Develop test protocols and release a final report on Shelf Life and Stability Studies in support of expiration dating.
* Perform test method validations to ensure accuracy, precision, selectivity, sensitivity, stability, and reproducibility of analytical or physical test methods used to assess the safety and efficacy of devices.
* Develop shelf life and stability test protocols as required for combination devices with Active Pharmaceutical Ingredient’s (API’s)
* Special projects as assigned.
Basic Qualifications:
Bachelor Degree in Engineering or Technical Sciences or equivalent work experience.
4 years minimum experience in Quality Engineering discipline including design controls, product/process validation, risk management, and technical problem solving.
A high level of competence in Quality Technology including statistical techniques, control charts, sampling plans, Quality costs, design of experiments, correlation and regression, analysis of variance, probability.
Strong Design Control understanding from concept to launch
Applied Knowledge of the requirements of FDA QSR, ISO13485and ISO 9001
Relevant experience with one or more of the following device technologies:
- Resorbable Polymers
- Active Pharmaceutical Ingredients- Combination
Devices
- Polymer Coating Processes
Additional Desirable Qualifications Skills and Knowledge:
* Ability to work with and motivate people.
* Good oral and written communication skills
/Category:, Job ID:, Standard Title:, Career Level:, Location/Division:, Relocation:, Posted Date:, Close Date:">
Industry Title
/Category: Medical Device/Quality Assurance
Job ID: 2010-4169
Standard Title: Senior Advanced Quality Engineer
Career Level: experienced
Location/Division: Warwick, RI/Davol
Relocation: Yes
Posted Date: 3/5/2010
Close Date: ..
C. R. Bard, Inc. (NYSE: BCR)is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 11,000 people in over 25 countries around the world. Founded more than 100 years ago, we pioneered many devices that are now the cornerstones of modern healthcare.
We expect the highest levels of quality, integrity, service, and innovation from our employees on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded.
Be Your Best at Bard and ultimately, you can have an impact on the lives of people around the world.
Apply for this position
* Refer a friend to this job
More information about this job:
Overview:
The position of the Sr. Advanced Quality Engineer is responsible to assure that new product designs and the processes for manufacturing them meet all Corporate and Divisional requirements with respect to safety and efficacy. This individual will represent quality interests and concerns on project teams and report to the Manager of Advanced Quality Engineering.
Essential Job Functions:
* Provide technical guidance to Quality Engineers, Quality Technicians, and Inspectors.
* Lead Quality Engineering Projects to improve Quality Systems and Procedures.
* Development of Test Protocols and Final Reports to support Regulatory 510K or PMA submissions.
* Development of the DFMEA, coordinating input from the other Design Sub-team members.
* Development of the Design Verification Protocol and the subsequent Design Verification Report
* Provide input into the project Design Input Summary (DIS), Product Performance Specification (PPS), Product Development Plan (PDP), and applicable design control documents as defined per Davol’s product development process
* Determine the degree of Biocompatibility testing required as per ISO10993 and company procedures.
* Develop test protocols and release a final report on Shelf Life and Stability Studies in support of expiration dating.
* Perform test method validations to ensure accuracy, precision, selectivity, sensitivity, stability, and reproducibility of analytical or physical test methods used to assess the safety and efficacy of devices.
* Develop shelf life and stability test protocols as required for combination devices with Active Pharmaceutical Ingredient’s (API’s)
* Special projects as assigned.
Basic Qualifications:
Bachelor Degree in Engineering or Technical Sciences or equivalent work experience.
4 years minimum experience in Quality Engineering discipline including design controls, product/process validation, risk management, and technical problem solving.
A high level of competence in Quality Technology including statistical techniques, control charts, sampling plans, Quality costs, design of experiments, correlation and regression, analysis of variance, probability.
Strong Design Control understanding from concept to launch
Applied Knowledge of the requirements of FDA QSR, ISO13485and ISO 9001
Relevant experience with one or more of the following device technologies:
- Resorbable Polymers
- Active Pharmaceutical Ingredients- Combination
Devices
- Polymer Coating Processes
Additional Desirable Qualifications Skills and Knowledge:
* Ability to work with and motivate people.
* Good oral and written communication skills
