Professional with at least 3 years of experience in regulated industries, mainly Medical and Automotive aligned to ISO13485 and IATF16949 standards. Must be an excellent communicator and demonstrate high leadership level to support different core teams on daily activities or supporting continuous improvement projects, customer concerns and maintain strong relationship with them. Ability to lead teams on different product business to comply with standards and regulatory requirements. Familiar with quality inspection role on NPI, APQP/PAPP/validation as applicable. Must possess technical problem-solving skills and familiar with standard techniques such as 8D's, 5 Why's, 7 steps and Ishikawa. Lean tools knowledge. Non conformance material handling and CAPAs as per ISOs and regulatory requirements.
Should be familiar with core tools such as SPC, Statistics, Validations.Demonstrate experience on audit program as auditor including process, product. LPAs audits. Knowledge of product and its technical requirements. Understanding of product specifications. Knowledge and experience on GD&T and metrology. Supply chain knowledge;inventories and kanban as well as ERP user experience i.e., Ifoflow,oracle, or similar.Experience or knowledge of EH&S requirements is desirable. Experience in customer portal management.
Knowledge and experience on measurement systems (MSA). Focused and capable to detect and improve inspection methods and controls in the company
Soft skills sought after: Organization, systemic and critic thinking, accountability, respectful, dynamic, flexible, analytic, trustworthy, follower, lead, team player, ethical, open-minded, diplomatic, observant, perceptive, versatile, tenacious, decisive, self-reliant, acting with fortitude, open to improvement, culturally sensitive, collaborative.
• To maintain communication with customer, lead and follow up customer visit/audits, surveys, and closing of all actions resulted from them.
• Participate as internal auditor. In charge of schedule and execute product, process audits and LPA
- BS degree in Electronics, Mechatronics or Electromechanical, industrial or other equivalent Engineering or aligned Bachelor degree profile.
- From 3 to 5 years of experience in Regulated companies. Preferable automotive or Medical
- Certified or demonstrate experience as as ISO13485/ IATF/ISO9001 internal auditor.
-CFR and FDA requirements knowledge.
-Preferible experience in automotive requirements ISO/TS16949 or IATF
Preferible Green belt or Black Belt Certified.
-CAPA system experience and use of investigation tools 8D, or statistic tools.
-Complaints System Management Experience and demonstrated customer communication for complaints follow up
-Validation knowledge as per CFR and ISO14385 requirements
|Área||Control de Calidad|
|Edad||Mayor de 30 años|