Responsibilities:
- As a Validation Engineer within the Mold & Capital Tooling Organization youll play a pivotal role on a global enterprise team collaborating with various sites around the this role youll facilitate or perform critical validation & qualification activities ensuring the seamless release of high-quality injection molded components that drive our mission forward.
- 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.
Requirements:
- 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 Solid works or AutoCAD.
- Experience with NPI and design transfers deliverables for injection moulded components.
- Experience within highly regulated industry.
- Hands on experience within production and enterprise environment.
Additional Information :
All your information will be kept confidential according to EEO guidelines.
Remote Work :
No
Employment Type :
Contract