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Quality Engineer

  • Anywhere

Company :
Perrigo Company plc

Location :
Grand Rapids, Michigan

Expiry Date :
Fri, 16 Apr 2021 23:59:59 GMT

Apply Job :
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Description :
Description Perrigo Company is dedicated to making lives better by bringing high quality and affordable self-care products that consumers trust everywhere they are sold. Help us do it. Responsibilities: Monitoring and acting as QA Department lead for PMI/cross-site SAP improvement projects (including travel to other sites as required) Develop and interpret user requirements with IT & S for Quality related SAP improvements and projects Develop, monitor, and provide SAP specific training to exempt QA personnel, identify and train non-exempt SMEs in specific job functions Monitoring and prioritizing outstanding IS requests related to SAP enhancements Perform security audits of SAP roles, minimally annually Perform quality review of SAP transaction documents, ensure accuracy and suitability of all SAP related SOPs and SWIs Troubleshoot SAP errors and discrepancies ad hoc, characterize identified gaps for remediation. Provide advanced new product development support as part of a cross-departmental project team. Provide guidance on design controls and ensure conformance to the process Write process validation protocols. Oversee protocol execution; writing the post-execution report and proper handling any deviations during execution. Assist with specification creation; aligning tolerances with risks during product development. Execute nonconforming material investigations, including root cause analysis, corrective actions, and material dispositions. Creation and annual updates of product risk management reports using risk management tools (D/PFMEA) and other risk management data. Execute complaint investigations, including root cause analysis and corrective actions.Requirements: Bachelors Degree required. Degree in scientific, information technology or closely aligned field preferred. Three years of experience in a pharmaceutical or medical device environment preferred. Ability to interpret and apply FDA regulations to company operating procedures is necessary. Demonstrated ability to organize multiple tasks and change priorities to meet project deadlines. Extensive functional knowledge of SAP required, preferably in QM module. Ability to communicate effectively at various levels in the organization and to interact directly with IT & S to define and interpret user requirements is required. Demonstrated ability to transfer SAP knowledge in a training environment is highly recommended. Working knowledge of Lean, 5S, and Six Sigma principles. Ability to use statistical sampling plans Periodic travel is required for this role. We are seeking a diverse applicant pool to ensure the diversity of our team reflects the end consumers we serve through our self-care mission. We are proud to be an equal opportunity employer that celebrates our team’s differences. Individuals of all races, ethnicities, nationalities, ancestries, religious creeds, sexual orientations, genders, gender identities and gender expressions, national origins, ages, mental and physical abilities, familial status,’ veterans status’, military status’ and more are encouraged to apply. TOGETHER, we make lives better.