Job Information
Insight Global Quality Engineer in Raynham, Massachusetts
Job Description
Complete validation & quality actions required for the introduction and delivery of new Hinge cast product line as well as support EUMDR validation assessment and rationalization.
The rate for this role varies from $40/HR to $50/HR depending on skillset, experience, and education.
We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, 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 . The EEOC "Know Your Rights" Poster is available here (https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf) .
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Skills and Requirements
Industry: Minimum of 4 years of experience in medical device manufacturing or other highly regulated industries. Understanding of investment casting (foundry processing) is preferred but not required.
Validation: Strong background in process validations (IQs, OQ/PQs, TMVs) is required.
Quality & Compliance: Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements). Raises Quality issues as appropriate. Proficiency in conducting non-conformance investigations and maintaining non-conformance records; strong investigation skills and ability to manage multiple investigations are essential. Experience in supporting Corrective and Preventive Actions (CAPA) preferred but not required; includes Action Plan (AP) and Effectivity Monitoring (EM) tasks.
Change Control: Experience with change control processing via PLM systems, good documentation practices (tracking edits between revisions), solicit review feedback and approvals.
Self-Starter: Demonstrated ability to work independently and proactively. Must be a team player and not shy about engaging with colleagues.
Can you describe the purpose of Installation Qualifications (IQs), Operational Qualifications (OQs), Process Qualifications (PQs) and Test Method Validations (TMVs) and what key elements are needed to support those validations? 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.