Описание

The Quality Engineer is responsible for end-to-end quality management per product families, starting from supplier selection and qualification, transfer to production processes and maintain supplier and process control during product lifecycle.

Responsibilities

Supporting quality-related activities throughout transfer to production and production.
Manage Process validation/ Verification activities including Suppliers guidance with Biosense process validation requirements, planning, execution, monitoring, reporting and approval
Support change control activities through production
Support robust key production processes (CTXs cascading, monitoring tools, PFMEA Activities reduce human error etc.)
Nonconformance & CAPA investigations
Leading improvement plans with suppliers
Contributing to operations Production stabilization, trend analysis, process improvements and supplier guidance.

Requirements

BSc or Practical Engineer / BSc in Engineering / BA degree or Quality Assurance, CQE is an advantage Qualification in Quality Assurance (CQE, CQM or CQA)
Practical knowledge of ISO13485, experience with medical device electromechanics manufacturing companies
Demonstrated knowledge of manufacturing principles, practices and procedures

Nice to have

Business Alignment, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Data Analysis, Detail-Oriented, Goal Attainment, Human-Centered Design, Internal Controls, Issue Escalation, Problem Solving, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards

We offer

Hybrid Work
Full time employment