המקום בו המומחים והחברות הטובות ביותר נפגשים
Your role:
Lead andSupport produces and completes Quality / Process Engineering related activities and documentation with limited supervision.
Lead andthe Qualification of Parts, identification of supplier processes for CtQ's, supplier process control plans to ensure part quality; ensuring that the supplied part meets specifications, and the control
Lead andlimits/tolerances for CtQ parameters are met in accordance with APQP – PSW quality requirements
Lead andSupport the qualifying and sustaining sub-processes of suppliers, including supplier audits.
Lead andSupport in ensuring that the components / products at the supplier (including spare parts and services) are released according agreed specification and quality requirements.
Lead and
Lead andSupport efforts to establish common approaches and working methods to drive PDLM-APQP process throughout the Supply Base in the assigned BG or Market.
Supports efforts in assuring that suppliers’ process capabilities are assessed at the supplier level to meet part quality requirements specifications, are complete and transferable to suppliers, and transferable to suppliers, and well documented in accordance with APQP-PSW process.
Works on issues where analysis of situation or data requires identification and review of relevant factors.
Exercises judgment within defined procedures and policies to determine appropriate action.
Own interpretation regarding assignments, based on own calculations and coordinates implementation of changes.
Provides direct supervision to professional individual contributors and/or skilled, support individual contributors (e.g., technicians, designers, support personnel).
Acts as advisor to unit or sub-units and may become actively involved, as required, to meet schedules and resolve problems.
Requirements
BS or above in an engineering (ie; mechanical / electrical / industrial)
years total industry experience with 2+ years of experience in a medical device or regulated industry in SQE role.
Knowledge, understanding with quality systems, quality tools and methodologies, including APQP-PPAP/PSW process Critical to Quality, FMEA, Root Cause Analysis , Pareto, 8-D, 5 Why, Audit training, skills, or willingness to learn; experience with auditing suppliers preferred.
Preferred Industry Experience: Automotive / Aerospace / Medical
Competencies and skills:
Execution knowledge of statistical methods, quality tools and methodologies (CtQ, SPC, APQP, FMEA, MSA/GR&R, Control Plans, SCAR, etc).
Strong Problem Solving skills and experience.
Six Sigma GB preferred.
Ability to work independently, think analytically, and apply methodical engineering problem solving skills required. Capable of performing root cause analysis and identifying solutions to complex manufacturing problems
Ability to influence others and build effective working relationships both internally and externally at various organizational levels.
Professional communication skills in English is a MUST, both oral and written.
Ability to travel up to 30+%.
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
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