Quality Engineer II

Mastech Digital is an IT Staffing and Digital Transformation Services company.
Mastech Digital

provides digital and mainstream technology staff as well as Digital Transformation Services for all American Corporations. We are currently seeking a

Quality Engineer II

for our client in the

Retail

domain. We value our professionals, providing comprehensive benefits and the opportunity for growth. This is a

Contract

position, and the client is looking for someone to start immediately.
Duration:

6+ Months Contract
Salary:

$60.00/Hourly on W2
Role: Quality Engineer II
Primary Skills: Quality Assurance
Role Description:

The

Quality Engineer II

must have at least 5+ years of experience. The Quality Engineer II is responsible for validation of analytical methods, cleaning, production process, equipment qualification, facilities/utilities qualification, and raw materials qualification.
Additionally, generate and maintain process FMEA for production processes, perform risk assessments for process related non-conformances and planned deviations, provide support and content for regulatory submissions, write master validation plans, protocols and reports, support equipment and facilities change controls, and perform validation impact assessment for change orders.
Top 3 Skills:
- Must be able to write validations
- Someone who is organized. Very fast paced company. Will have more than one project at a time. Need to be able to multitask, go to multiple meetings, and keep to project-timelines.
Responsibilities:
You may be asked to perform other function-related activities in addition to the responsibilities below as reasonably required by business needs.
- Author master validation plans and reports.
- Author and execute validation protocols and reports (Analytical Methods, Equipment, Facilities/Utilities, Raw Materials, Process, and Cleaning).
- Review the quality, validation impact, and completeness of document change order requests and change controls (Equipment or Facilities).
- Determine validation strategy based on acceptable risk-based approach.
- Lead cross-functional team to write PFMEAs under limited supervision.
- Perform process risk assessment for Non-Conformance Events (NCEs) and planned deviations (PDV).
- Support cross-functional teams during New Product Introduction (NPI) and Sustaining projects.
- Review regulatory submissions and/or notifications under limited supervision.
- Propose improvement projects with supporting data, flowcharts, etc.
- Assist in developing/updating departmental procedures and other controlled documents.
- Evaluate adequacy of specifications for new or modified process designs under limited supervision.
- Lead department and cross-department projects under limited supervision. Determine QE deliverables and assist in generating project timelines.
- Assist QE management in Material Review Board (MRB) and Production Response Team (PRT) meetings.
- Participate in department process improvement goal(s).
- Assist in development, maintenance, and reporting of department metrics.
- Provides management with status updates on assigned responsibilities, goals and escalate issues in a timely fashion.
Note:
- Oligonucleotide experience would be good to have
- Typical day/daily tasks: Assessing changes to documents
- Assessing non conformances
- Writing protocol/report
Education:

Bachelor’s degree in Computer Science, Electrical/Electronic Engineering, Information Technology or another related field or Equivalent
Experience:

Minimum 5+ years of experience
Relocation:

This position will not cover relocation expenses
Travel:

No
Local Preferred:

Yes
Note: Must be able to work on a W2 basis (No C2C)
Mastech Digital provides IT associates in digital and mainstream technologies, Digital Transformation Services around Salesforce.com and SAP HANA, as well as Digital Learning Services. Mastech is listed on the NYSE under the symbol MHH.
CORPORATE HEADQUARTERS
1305 Cherrington Parkway
Building 210, Suite 400
Moon Township, PA 15108
Toll-free: +1 800.627.8323
Phone: +1 412.787.2100
Fax: +1 412.494.9272

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