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Software Quality Engineer

DivIHN Integration Inc

Job Description

DivIHN (pronounced Divine) is a nationally-recognized Business Technology Solutions and Staffing services provider headquartered in Chicago. Since our formation in 2002, we have been trusted by Fortune 500 organizations to help them locate and hire best-in-class talent through our Award-winning Professional Workforce Solutions program. Check out our careers page to see all of our job openings: http://divihn.com/careers/find-a-job/ One of our BEST F500 customers has engaged us to help them hire a Software Quality Engineer to be available to work out of their office in Tewksbury, Massachusetts; details can be found below. 10 months Please apply or call one of us to learn more
For further information please contact our Talent Specialist:
Aditya at (630) 847 1030
Title: Software Quality Engineer Duration: 10 months ( Potential to convert to fulltime in 2022) Location: Tewksbury, MA (- 100% remote, some travel to other Corning Life Sciences plants/locations may be required. Candidate must be willing to work EST hours.)


Non-exempt

- Focus of position is validating software systems (not developing or installing)

Bachelors's is a hard requirement. Minimum of 5 years experience in the pharmaceutical, medical device, and/or biotechnology industry manufacturing and product software quality engineering and/or assurance experience.
Background in 21 CFR Part 11-compliant software validations, including systems such as inspection systems, vision systems, manufacturing execution systems, and material handling systems
SAP software validation experience (the worker will be validating in SAP)
Knowledge of applicable industry standards, regulations, and requirements (e.g. GAMP, medical device and pharmaceutical GMPs, ISO 9001, ISO 13485, Quality Systems Regulations 21 CFR part 820, EU IVDR and MDR)


Summary:
---------------------------------------------------------------------------------------------------------------------
Reporting directly to the CLS Transformation Business Advisor, Quality and Regulatory, this position uses industry best practice and quality engineering principles to create and enforce a rigorous software validation program as part of overall product quality architecture commensurate to the ever-evolving customer and business needs. This includes, but is not limited to, all stages of product Innovation (and Design/Development Controls) and business/manufacturing/quality software system implementation.

This position works closely with other functions within the organization (Manufacturing, RandD, Quality, Engineering, Procurement and Business Operations) to develop and implement a standardized, lean, compliant approach to verifying software meets or exceeds internal/external customer and regulatory expectations

Education:
---------------------------------------------------------------------------------------------------------------------
BS degree in a field relevant to the position

Experience:
---------------------------------------------------------------------------------------------------------------------
Minimum of 5 years of pharmaceutical, medical device, and/or biotechnology industry manufacturing and product software quality engineering and/or assurance experience.

About us: DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.

DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.

Job Requirements

SAP, QA, product software
Apply
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Job Snapshot

Location US-MA-Tewksbury
Employment Type Contractor
Pay Type Hour
Pay Rate $55.00 - $58.00 /Hour
Store Type Other

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Snapshot
DivIHN Integration Inc
Company:
US-MA-Tewksbury
Location:
Contractor
Employment Type:
Hour
Pay Type:
$55.00 - $58.00 /Hour
Pay Rate:
Other
Store Type:

Job Description

DivIHN (pronounced Divine) is a nationally-recognized Business Technology Solutions and Staffing services provider headquartered in Chicago. Since our formation in 2002, we have been trusted by Fortune 500 organizations to help them locate and hire best-in-class talent through our Award-winning Professional Workforce Solutions program. Check out our careers page to see all of our job openings: http://divihn.com/careers/find-a-job/ One of our BEST F500 customers has engaged us to help them hire a Software Quality Engineer to be available to work out of their office in Tewksbury, Massachusetts; details can be found below. 10 months Please apply or call one of us to learn more
For further information please contact our Talent Specialist:
Aditya at (630) 847 1030
Title: Software Quality Engineer Duration: 10 months ( Potential to convert to fulltime in 2022) Location: Tewksbury, MA (- 100% remote, some travel to other Corning Life Sciences plants/locations may be required. Candidate must be willing to work EST hours.)


Non-exempt

- Focus of position is validating software systems (not developing or installing)

Bachelors's is a hard requirement. Minimum of 5 years experience in the pharmaceutical, medical device, and/or biotechnology industry manufacturing and product software quality engineering and/or assurance experience.
Background in 21 CFR Part 11-compliant software validations, including systems such as inspection systems, vision systems, manufacturing execution systems, and material handling systems
SAP software validation experience (the worker will be validating in SAP)
Knowledge of applicable industry standards, regulations, and requirements (e.g. GAMP, medical device and pharmaceutical GMPs, ISO 9001, ISO 13485, Quality Systems Regulations 21 CFR part 820, EU IVDR and MDR)


Summary:
---------------------------------------------------------------------------------------------------------------------
Reporting directly to the CLS Transformation Business Advisor, Quality and Regulatory, this position uses industry best practice and quality engineering principles to create and enforce a rigorous software validation program as part of overall product quality architecture commensurate to the ever-evolving customer and business needs. This includes, but is not limited to, all stages of product Innovation (and Design/Development Controls) and business/manufacturing/quality software system implementation.

This position works closely with other functions within the organization (Manufacturing, RandD, Quality, Engineering, Procurement and Business Operations) to develop and implement a standardized, lean, compliant approach to verifying software meets or exceeds internal/external customer and regulatory expectations

Education:
---------------------------------------------------------------------------------------------------------------------
BS degree in a field relevant to the position

Experience:
---------------------------------------------------------------------------------------------------------------------
Minimum of 5 years of pharmaceutical, medical device, and/or biotechnology industry manufacturing and product software quality engineering and/or assurance experience.

About us: DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.

DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.

Job Requirements

SAP, QA, product software
Software Quality Engineer Apply now