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Senior Quality Engineer (Quality Lead)

This job posting is no longer active.

Description

Phillips-Medisize, a Molex company, is a leading global outsource provider of design development and manufacturing services to the medical (medical device, diagnostics, and drug delivery products) and commercial (automotive, consumer, and defense) markets. 85% of the company's total revenue comes from drug delivery, medical device, primary pharmaceutical packaging, and diagnostic products. Phillips-Medisize facilities are FDA registered for clean-room molding, medical device assembly, drug handling and packaging, sterilization management, and final device packaging under ISO 9001, ISO 14001, ISO 13485, FDA 21CFR 820, FDA 21CFR 210/211.


Phillips-Medisize Polska is hiring a

Senior Quality Engineer (Quality Lead)

based in the region of Katowice/Tychy


The main scope of this position is to support the Plant Manager of the new plant in Poland with establishing, implementing and maintaining of the Quality Management System and the Plant start-up.


What You Will Do In Your Role

  • Ensure that product and processes comply with the relevant requirements of the Quality Management System and customer requirements and appropriate standards 
  • Responsible for continual improvement activities to enhance the Quality Management System 
  • Developing trainings and train employees with regard to quality and improvement subjects 
  • Handling of Out of Specification results 
  • Solving of internal non-conformities and planned deviations, (Analyse failure and cooperate with set up of corrective and preventive actions) 
  • Maintain the areas for non-conforming products 
  • Manage quality metrics including cost of poor quality 
  • Timely review of batch records and release of corresponding product 
  • Implement / update procedures to assure compliance with Quality standards, divisional QMS and regulatory requirements 
  • Participate in daily/weekly meetings, representing quality 
  • Maintenance of site internal audit program and vendor audit programs 
  • Perpetuates a culture of quality mindset across all site functions 
  • Must ensure timely closure of all pertinent Quality Management System process’ such as Compliant, Non-Conformance, Change Management, CAPA etc. 
  • Engagement with pertinent Divisional Quality initiatives 
  • Interface with engineering and production to ensure compliance with customer/divisional and regulatory requirements 
  • Work with technical staff in performing root cause analysis and implementing corrective and preventive actions to preclude recurrence, develop and improve processes to reduce variability 
  • Propose process improvements based on analyses of internal data 
  • Cooperate with technical staff in performing of FMEA 
  • Cooperate with SCAR handling issued based on NCR reports, improve process for supplier data submission to reduce internal inspections 
  • Work in compliance with current good manufacturing practice 
  • Provide records in compliance with good documentation practice 


The Experience You Will Bring

Requirements:

  • Bachelor’s degree in engineering and knowledge of Quality Management Systems (ISO 9001, ISO 13485, CFR 820); Insight in CFR 210 / 211 and EUMDR would be advantageous 
  • Cleanroom Controls and Function, Statistical Techniques and Good manufacturing practice (GMP) 
  • Effective presentation / communication skills in English and Polish - both on min. level C1 
  • Thinking in solutions, socially skilled and communicative, ability to motivate and influence people to achieve customer satisfaction 
  • Experience with injection moulding, automated and manual assembly processes 
  • Experience in Interaction with Notified Bodies and Competent Authorities 


What Will Put You Ahead

  • 5+ years of experience in a manufacturing company, preferably medical devices' production 
  • Significant leadership experience 
  • Having worked on New Product Introductions 


With your application you agree that your information will be recorded in our files (up to 6 months after finalizing the position) and if necessary, forwarded to affiliated companies. 

We are an equal opportunity employer. 

As part of Koch Industries, one of the largest private companies in the world, Phillips-Medisze is offering international career development within one of the leading global players in the drug delivery device and connected health space for innovation, development and manufacturing services and solutions.

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This job posting is no longer active.

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