Research and document packaging gap assessment for sterile and non-sterile packaging variations for existing product platforms against MDR requirements and latest packaging regulations.
Review existing Design Verification documentation and associated attachments.
Review existing Stability (Aging) documentation and associated attachments.
Review existing Installation Qualification (IQ), Operational Qualification (OQ), and Performance/Process Performance Qualification (PQ/PPQ) documentation and associated attachments.
Review Risk Management documentation including but not limited to FMEAs, Risk Management Plans (RMP), and Risk Management Reports (RMR) related to device packaging.
Review and approval of packaging documentation related to ongoing Regulatory MDD/MDR projects.
Revise/create packaging related documentation including but not limited to protocols, reports, technical summaries, and other documents as needed to support ongoing regulatory efforts.
Strong Medical Device experiences
Deep MDR/MDD regulations understanding
Strong packaging engineering related experience
Bachelor's Degree in Engineering or Scientific field with a minimum of 8 years including either industry or industry/education
Required or Master's Degree or equivalent in Engineering or Scientific field with a minimum of 7 years including either industry or industry/education
Required or Ph.D. or equivalent in Engineering or Scientific field with a minimum of 6 years including either industry or industry/education Required
We are an equal opportunity employer and make hiring decisions based on merit. Recruitment, hiring, training, and job assignments are made without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, or any other protected classification. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
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