Manufacturing BOM / Configuration SME

Job Description Insight Global is seeking a Manufacturing BOM / Configuration SME who will be responsible for authoring and implementing a configuration and change management procedure for the revision and release of manufacturing bills of materials (mBOM) as part of the engineering BOM and New Product Introduction (NPI) process. 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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•  8-10+ years of experience leading or supporting regulated medical device manufacturing technical operations, specifically supporting NPI transition from R D to commercial manufacturing.
•  Experience with configuration management and BOM creation and implementation across R D, Manufacturing, Quality, and Supply Chain organizations.
•  Experience with SOP writing and quality management systems.
•  Experience with change control processes, including impact assessments, risk evaluation, documentation, approvals, and change closure.
•  Experience with electronic batch records and master records (Agile PLM or Windchill PLM preferred).