Quality Engineer
Description
Phillips Medisize, a Molex Company is hiring a
Quality Engineer
based in our manufacturing facility in Trhové Sviny, Jihočeský kraj, Česká republika
The main scope of this position is to support the growth and development of the Quality Assurance organization at PMCZ and assure a permanent state of quality compliance,
Quality and Compliance activities on an operational and tactical level. For both production and pre-production. Also required to consult on a strategic level.
Back-up for Quality Manager PMCZ related to Metrology.
What You Will Do In Your Role
- Lead or participate in quality improvement projects
- Develop trainings and train employees with regard to quality and improvement subjects
- Coordinate the QA-activities
- Sustain and set-up a Quality Assurance organization including adding new (innovative) capabilities to meet changing and increasing customer needs
- Generate, review and authorize Quality related documents
- Maintain the CAPA (Corrective and preventive actions) system
- Maintain the complaint handling system
- Investigate deviations and NCR’s (non-conformances), by determining the root cause and implementing corrective and preventive action
- Analyse data concerning production, processes and the quality management system and propose improvements
- Release products, processes and equipment based on statistical data
- Execute internal and external audits including reports
- When requested, accompany Customer and Regulatory Body Auditors
- Communicate results of the KPI’s and quality goals to the Quality Manager
- Act as a strong team-builder within the quality team
- Show professional can-do attitude
The Experience You Will Bring
Requirements:
- Good manufacturing practice
- Good documentation practice
- Expertise in statistical techniques
- Risk management experience
- Having demonstrated problem solving and root cause analysis skills (especially for injection moulding process failures and related defects)
- Frequent PC/reporting work
- SAP knowledge and experience very nice to have
- Good communicator
- Gets on well with others
- Ethical, open minded, diplomatic
- The ability to perform under pressure
What Will Put You Ahead
- Engineering education (technical field, plastic technology, Injection Moulding)
- Strong understanding of the Quality Management System for the medical and drug delivery devices (min. ISO 13485, FDA 21CFR820)
- Fluent Czech or Slovak is a must have
- Competency in English (written and spoken)
LI-JJJ74
