Validation Engineer Medical
Validation Engineer Medical
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Salary Not Disclosed
1 Vacancy
Job Description
Ensure proper qualification and validation of suppliers and their processes ensuring supplier meets the requirements for producing high-quality reliable products.
Developing and executing validation plans conducting audits and managing the overall PPAP process to ensure compliance with ISO 13485/ Medical standards.
Write review and approve validation change controls and validation protocols IQ OQ PQ PV standard operating procedures standard calibration methods standard test methods specifications CAPAs and exception reports.
Strong documentation skills - Accurately recording and managing validation processes in compliance with internal SOPs and external regulations.
Review test results and measurements to identify discrepancies.
SPC (Statistical Process Control)
Knowledge on ISO 13485 FDA GMP ISO 14971 FDA CFR 820
Clean Room experience and medical prod mfg exp (added advantage).
Communicates with stakeholders obtains stakeholder engagement to ensure the end products or processes will solve the business problems.
Qualification:
Bachelors degree with a minimum of 5-7 years of experience in a regulated environment OR an advanced degree with a minimum of 3 years of experience.
Minimum of 5 years of professional experience in a relevant field
Experience with Agile PLM and SAP or BPCS ERP systems
Experience with CAD model with use of Solidworks or AutoCAD
Experience with NPI and design transfers deliverables for injection molded components
Experience within highly regulated industry
Hands on experience within production and enterprise environment
Pi-square technologies is a Michigan (USA) Headquartered Automotive Embedded Engineering Services company Synergy Partner for major OEMs and Tier 1s and their implementation partners in Automotive Embedded Product Development Projects Requirements Analysis Software Design Software Implementation Efficient Build Release Process and turnkey software V & V Services. We have more than 20 years of industry expertise with specialization in the latest cutting-edge automotive technologies such as Infotainment connected vehicles Cyber security OTA and Advanced Safety/ Body electronics.
Employment Type
Full-time
