Client:Leading Medical Device client
Job type:Contract
Duration:12 Months
Location:Plymouth, MN, 55441
Title:Sr Design Quality Engineer
ID :5084
Job Description:
Position Purpose: The primary purpose of this position is to provide Quality Engineering support to the successful development of Client products. This individual will be expected to apply his/her knowledge of design control principles and quality engineering techniques to development efforts and ongoing manufacturing support as needed. In parallel, this person shall also ensure the products are developed and manufactured in accordance with applicable industry standards, regulatory requirements and customer requirements.
Responsibilities:
•Identifies and manages risk throughout the development process through the creation of the risk management file and use of FMECA and/or other risk management tools.
•Contributes to Quality System updates such as risk management SOP updates and ensuring site level SOP’s comply with external standards like ISO 14971.
•Develops master test plans that encompass design verification, design validation and process validation activities.
•Evaluates test protocols and reports to ensure that the testing is sufficient to meet regulatory requirements and quality objectives.
•Provides input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested.
•Assists with the analysis and resolution of design or manufacturing problems as these arise.
•Analyzes and investigates returned clinical investigation products to determine the cause for return.
•Contributes to design input requirements from experience with previously reported problems from internal sources (non-conforming material reports, yield, rework) or external sources (customer complaints), competitive devices and/or other similar products.
•Participates in supplier selection process and component specification reviews to ensure that purchased items meet Client specifications.
•Specifies quality characteristics and inspection plans for components, subassemblies, and finished devices
•Evaluates and dispositions nonconforming materials and products used in design and clinical builds, to arrive at the most economical disposition, while meeting all quality system requirements
•Comply with applicable FDA and international regulatory laws/standards and the Client Code of Conduct.
•Perform related duties as assigned.
Required Knowledge and Skills:
•Self-motivated and committed to a team approach
•Strong interpersonal, organizational and project management skills
•Strong oral and technical writing skills
•Ability to make decisions in a fast pace environment
•Demonstrated problem solving skills
•ASQ certification in Quality Engineering desirable
Qualifications:
•Bachelor’s Degree in Science or Engineering (or related field)
•5 - 10 years experience in Quality Engineering in the medical device industry (or related industry). Experience in related engineering areas, e.g. R&D, Process Development, or Manufacturing may also be applicable if experience includes work responsibilities listed above
If you are interested in this job then you can reach me at 2015249600 X 944
Job type:Contract
Duration:12 Months
Location:Plymouth, MN, 55441
Title:Sr Design Quality Engineer
ID :5084
Job Description:
Position Purpose: The primary purpose of this position is to provide Quality Engineering support to the successful development of Client products. This individual will be expected to apply his/her knowledge of design control principles and quality engineering techniques to development efforts and ongoing manufacturing support as needed. In parallel, this person shall also ensure the products are developed and manufactured in accordance with applicable industry standards, regulatory requirements and customer requirements.
Responsibilities:
•Identifies and manages risk throughout the development process through the creation of the risk management file and use of FMECA and/or other risk management tools.
•Contributes to Quality System updates such as risk management SOP updates and ensuring site level SOP’s comply with external standards like ISO 14971.
•Develops master test plans that encompass design verification, design validation and process validation activities.
•Evaluates test protocols and reports to ensure that the testing is sufficient to meet regulatory requirements and quality objectives.
•Provides input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested.
•Assists with the analysis and resolution of design or manufacturing problems as these arise.
•Analyzes and investigates returned clinical investigation products to determine the cause for return.
•Contributes to design input requirements from experience with previously reported problems from internal sources (non-conforming material reports, yield, rework) or external sources (customer complaints), competitive devices and/or other similar products.
•Participates in supplier selection process and component specification reviews to ensure that purchased items meet Client specifications.
•Specifies quality characteristics and inspection plans for components, subassemblies, and finished devices
•Evaluates and dispositions nonconforming materials and products used in design and clinical builds, to arrive at the most economical disposition, while meeting all quality system requirements
•Comply with applicable FDA and international regulatory laws/standards and the Client Code of Conduct.
•Perform related duties as assigned.
Required Knowledge and Skills:
•Self-motivated and committed to a team approach
•Strong interpersonal, organizational and project management skills
•Strong oral and technical writing skills
•Ability to make decisions in a fast pace environment
•Demonstrated problem solving skills
•ASQ certification in Quality Engineering desirable
Qualifications:
•Bachelor’s Degree in Science or Engineering (or related field)
•5 - 10 years experience in Quality Engineering in the medical device industry (or related industry). Experience in related engineering areas, e.g. R&D, Process Development, or Manufacturing may also be applicable if experience includes work responsibilities listed above
If you are interested in this job then you can reach me at 2015249600 X 944