Job Information
Insight Global Sr. Quality Engineer in Raynham, Massachusetts
Job Description
TARGET PAY RATE BETWEEN 30-40/HR.
The daily tasks in scope of this role include but are not limited to the following:
Ensures effective quality strategies are created for validation of processes to establish equivalency between the current processes and project(s).
Partnering with cross functional teams to ensure sound validation strategy and smooth transitions to production go-live.
Developing, writing, reviewing, maintaining and revising manufacturing documentation, i.e., Process Work Instructions, Manufacturing Specifications, Inspection Procedures to support product Manufacturing.
Developing, writing, and reviewing IQ/OQ/PQ documentation for manufacturing processes and/or manufacturing equipment in conjunction with Manufacturing Engineering partners.
Developing, writing, and reviewing various validation deliverables, i.e. CSV-E, Engineering Studies, etc.
Developing, writing, reviewing, and updating relevant Process Risk Documentation (pRAS, pFMEA, FMCA). Document, justify, review or analyze whether an inclusion of a streamlined automated process will not increase the risk level beyond capability of current controls or whether change will result in potential non-compliance to a required standard.
Assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. Determine effectiveness of these techniques on previously implemented improvements
Ensuring adequate documentation where necessary within the Quality System
In order to successfully deliver on the above the incumbent will apply comprehensive and diverse knowledge of Engineering and Quality Engineering principles and practices as well as problem solving, risk management skills, and people management/communication skills.
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com .
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Skills and Requirements
Required:
A minimum of 4-6 years of related experience.
Must have Process Validation experience.
Good technical understanding of manufacturing equipment and processes.
Knowledge of statistical software packages (e.g. Minitab) with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision making.
Experience working in both an FDA and European regulatory environment in manufacturing/operations.
A thorough understanding of GMP/ISO regulations and validation regulations
The ability to perform "hands on" troubleshooting and problem solving.
Knowledge of Microsoft Office (Word, Excel, PowerPoint, Outlook).
In-depth knowledge of product/process Risk Management (FDA and ISO standards).
Strong communication and interpersonal skills.
Must have the ability to function in a team-based manufacturing environment.
The ability to collaborate with all levels of management in a cross-functional team environment. Preferred:
Technical training and experience using Statistics, Lean and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc.
The ability to perform "hands on" troubleshooting and problem solving is preferred. The ability to think on the feet and providing sound judgment is highly desired.
A thorough understanding of GMP/ISO regulations and validation regulations.
Demonstrated project management and project leadership abilities are preferred. null
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.