Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Responsibilities and AuthoritiesDrive improvements and reduce risk in our Supply Chain at our Manufacturing site. Primary responsibilities of the SQE will be to qualify new suppliers, analyze and improve supplier performance, implement corrective actions or quality plans at supplier sites to prevent repeat non-conformances using Quality Tools (FMEA, CpK,  GR&R, SPC, etc.) and perform supplier audits.Develops and ensures the execution of objectives for the control of suppliers, contract manufacturers and service providers in alignment with company goals and objectives; including assuring the supply of timely, acceptable product and services.Develops and/or continuously improves procedures, policies and quality assurance methodologies including but not exclusive to end of life materials/components, product development process and sustaining engineering. Collaborates with Procurement, R&D and Operations to effectively define roles and responsibilities and supply priorities and actions.Review and approves supplier records including quality agreements and SCARs/CAPAs.Participates in the CAPA Review Board meetings and other critical decision-making meetings when required to define and assess supplier’s roles, responsibilities and efficiency.Qualification   Degree in Engineering/Operations Management, Biological Sciences or equivalent.Experiences Supplier Quality role with Medical instruments/devices more than 2 years.Competencies PreferredISO13485 or/and ISO 9001 internal Auditor certifiedKnowledge of IS0 13485 and 21 CFR Part 820.Lean Six Sigma Green or Black Belt certified.Work independently and self-motivated.Excellent oral and written communication skills