Magic Leap is seeking a proactive and professional engineer to drive establishment, implementation, and maintenance of a robust Quality Management System to enable sustainable world class performance. Processes included, but are not limited to: document management, internal audit, CAPA, quality training, change management. Strong organizational skills are essential to succeed in this role.
- Design and configure SQE solutions to incorporate business processes
- Manage cross-functional projects and teams to meet project goals and schedules.
- Write and propose Functional Specifications in support of SQE department.
- Lead business process and QMS solutions discussions and to present and define/configure processes and workflow solutions for clients
- Develop, modify, apply, and maintain quality systems procedures.
- Develop and drive SQE program metrics in order to improve the productivity and efficiency of the SQE department
- Collaborate with internal customers to ensure quality standard are in place and in compliance, including the scheduling, planning, and communication of internal meetings
- Minimum 4 years of relevant experience working within Quality Assurance or a related field.
- Experience with defining business requirements and knowledge of business process definitions
- Experience with training and support of end users
- Broad knowledge of quality methods and systems (statistics, auditing, problem solving, sampling, metrology, change management, etc.)
- Innovator of change and extreme desire for continuous improvement
- Systems thinker who can plan a well-integrated QMS where each element has solid linkages to other related functions.
- Ability to work independently and inquisitively with minimal direction.
- Excellent written, presentation and interpersonal skills are required
- Deep knowledge of mechanical and plastic injection moulding processes
- Ability to manage suppliers offshore / remotely to deliver the best in quality performance
- Familiar with PPAP , QMS Audits, 8D methodology, Quality Improvement Programs
- Rapid change environment resulting in changes in parts and suppliers
- Bachelor’s degree (minimum) in engineering, science or related discipline. MS preferred
- All your information will be kept confidential according to Equal Employment Opportunities guidelines.
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Within the framework of several engineering projects in the French–speaking area of Switzerland, we are looking for a Supplier Quality Engineer (SQE) for one of our clients within the Life & Science industry.
- Participate in an effective Supplier communication process.
- Develop and maintain inspection procedures for Receiving Inspection.
- Follow Standard Operations Procedure (SOP)
- Generate Supplier Corrective Actions (SCAR) as required and follow up with Suppliers for completion/closure.
- Perform Corrective Actions and Preventive Actions (CAPA)
- Participate in the redaction of reports and/or manuals
- Participate in non-conformity reviews and assessments
- Participate in risk assessment processes.
- Participate in the development of partnerships with key Suppliers.
- Participate in the assessment and selection of Suppliers of key commodities.
- Participate in the development of purchased component/assembly requirements.
- Assist suppliers with process improvement initiatives.
- Assist in the development of Supplier quality plans for supplied materials.
- Participate in the establishment of Supplier performance metrics.
- Conduct Supplier process and performance audits.
- Perform/Review Supplier process validations.
- Participate in continuation engineering activities as required.
- A bachelor's degree in engineering or a master's degree in Industrial or Mechanical Engineering or in a related field
- An interest for quality in the medical sector
- Minimum 5 years of experience in a similar position, including experience in Quality in the Medical Device sector.
Tools and techniques you master:
- Quality Management System (QMS) softwares
- Medical Device Standard (ISO 13485)
- Corrective Actions, Preventive Actions (CAPA)
- Out of Specification (OOS)
- Standard Operation Procedure (SOP)
In addition to your technical skills:
- Strong analytical and problem-solving skills
- Your organized mindset and your analytical skills bring a benefit to all stakeholders
- Ability to organise, plan and execute multiple tasks to tight schedules
- You have a hands-on mindset.
- You are fluent in English.