Job Vacancy

Quality & Technical Support Engineer

Introduction

Softbox Systems is an award-winning temperature control-packaging innovator that has been designing and producing high performance passive temperature control packaging systems for over 20 years. We offer consistent quality to our clients from our strategically located global manufacturing sites throughout EMEA, Americas, India and Asia Pacific.

We have formed long standing partnerships with the world’s leading biotech, pharmaceutical, clinical research and logistics companies, and apply innovative thinking to overcome the challenges that our clients face in managing the Cold Chain when shipping temperature sensitive commercial and clinical trial products.

Job Description

Location: Schiphol, Netherlands &  Atlanta, US

As part of the fight against Covid, in partnership with our key clients, Softbox has developed and implemented one of the world’s largest fleets of reusable temperature-controlled packaging solutions and established two world class service centres to support the refurbishment and reuse of Ultra Low Temperature (ULT) Shippers.

The Quality & Technical Support Engineer will be responsible for monitoring and improving the quality of the service centre operational processes and outputs, to ensure products consistently meet established quality standards –  including analysis, assessment and solution implementation of any process issues where required.

Realised through the design of quality methods and testing systems to reflect efficiency, reliability and performance – coordinating with onsite and wider teams to implement suitable quality measures and developing quality control systems for inspection of materials, equipment, processes and products.

Overseeing everyday manufacturing and operational activities is imperative to this role, with a duty for training needs analysis and administration of operatives on applicable work procedures and equipment use.

Role and Responsibilities

• Softbox ULT Service Centre

• Support the implementation and adherence of onsite Operational, Quality, Technical and IT SOP’s with focus on training needs analysis and competency to ensure absolute compliancy:
  • Stage 1 shipper and logger specifications, build sequences and processes.
  • Stage 2 shipper and logger specifications, release sequences and processes.
  • Stage 3 shipper and logger specifications, return sequences and processes.
• Plan, execute, and oversee inspection of in-process and outbound product to confirm quality conformance to specifications and agreed quality deliverables with Client Distribution Centres (DC’s).
• Defining product AQL’s and adopting this to establish a harmonised ‘Defect Classification System’ (Minor, Major, Critical).
• Capturing and categorising identified product nonconformance on return reports, and recording of data within issues logs.
• Assisting onsite operations and local quality teams to develop the tracking, documenting and reporting quality levels / rejections for route investigation and operational trend analysis (KPI’s) – engagement with ULT Service Centre, Logger Partner and Client DC’s on Complaints & Deviation CAPA.
• Look for continuous improvement opportunities on interaction and processes between ULT Service Centre & Client DC’s – providing onsite awareness, knowledge and training of product specifications, standards and best practices.
• Maintain detailed awareness of ULT shippers and associated build materials, product design, product performance, manufacturing process, quality control procedures and checks.

• Coordinating and collaborating with cross-functional support teams to achieve service centre operational objectives and improve onsite systems and processes:
  • Supply Chain
  • Quality
  • Technical
  • Exchange
  • IT
  • Manufacturing Engineering (IQ/OQ/PG)
• Liaise with other ULT Service Centre global site regions and teams to share required best practice, and maintain close working relationship with (HQ) Technical Department on product design evolution and process developments.
• Proactive development and implementation of quality control systems – setting detailed guidelines on what needs to be checked and what the quality standards are.
• Determine quality metrics for all manufacturing procedures – monitor, statistical analysis and reporting of quality performance to senior management.
• Inspect and test materials, equipment, processes, and products to ensure quality specifications are met.
• Investigating, analysing and troubleshooting product complaint or production issues, developing corrective actions, solutions, and improvements to overcome them – in line with QA Investigation (FEMA Analysis / CAPA / 8D) standard practices and techniques.
• Ensuring Change Control (Management) and Internal Auditing practice is supported for any associated service centre processes, operational systems, ULT shipper design developments in compliance with ISO 9001:2015 standards.
• Training onsite teams and operatives on required quality standards and work instructions, with training competency and ongoing development plans.

KPIs

• All KPIs will initially be focused on driving continuous improvement initiatives onsite at the Softbox ULKT Service Centre:
  • Quality improvements
  • Internal auditing
  • Process improvements
  • Efficiency / productivity gains
  • Service improvements
  • Zero Defect (product compliancy to specification) vs Customer Complaints %

Person Specification

• Educated to Bachelor’s degree – preference in Quality, Mechanical Engineering, Industrial Engineering or Related Field.
• Hands on experience with QMS quality assurance testing methodologies and tools – significant industry experience 5+ years.
• Demonstrated knowledge of testing best practices, version control practices and defect management practices.
• Direct client engagement and interaction on Quality Complaints & CAPA.
• Critical thinking
• Analytical skills
• Numerical skills
• Interpreting technical drawings & specifications.
• Shares and works to best practice principles
• Tackles problem solving in a logical way to arrive at the root cause.
• Meeting deadlines and multitasking.
• Planning, organizing and time management.
• Team working skills – working in close coordination with other teams throughout the service facility (as well as potential for interaction with suppliers and customers).

Application

NO AGENCIES PLEASE

Job Types: Full-time, Permanent

Competitive salary plus Performance and Company bonus scheme

To apply and for more information, please contact:

Europe & UK: Rebecca Herreros — [email protected]

US: Carrie Dale – [email protected]