Europlaz Technologies is a leading contract medical device manufacturer

Europlaz Technologies leading contract medical device manufacturer

Medical Device Quality Engineer - Customer Quality

 

Europlaz Technologies Ltd is a medical device contract manufacturer supplying finished devices, services and support to OEM medical device manufacturers around the world. We develop, design and manufacture a broad range of medical products and have state of the art injection moulding and cleanroom assembly facilities. Headquartered in Essex, an hour from East London, we offer an exciting opportunity for an experienced Quality Engineer to help the company reach our ambitious goals.

 

 

Company Overview: 

Europlaz Technologies was first founded in 1975 as an injection moulding company and tool making specialist. Since then the company has evolved into a full service Medical device manufacturer specialising in delivering finished medical devices, from concept to completion.  The company has four class 7 cleanrooms for moulding and assembly with two new cleanrooms due to open in 2018. Our workforce includes associates and professionals in Engineering, Manufacturing, Purchasing, Sales, Quality, Finance and Human Resources. The Europlaz team strives for continuous innovation with the end goal of delivering for our customers. 

 

Role Summary/Purpose: 

As Quality Engineer at Europlaz Technologies, the role will require strong technical and analytical background coupled with a thorough understanding of medical device manufacturing processes, preferably including injection moulding and cleanroom assembly. This role will focus on implementing process controls by identifying process issues, implementing corrective actions and driving sustainable process improvements. 

Under general direction and guidance, this role is responsible for developing, monitoring and implementing all quality attributes for assigned programs and products to ensure compliance with Company, customer contractual requirements, regulatory requirements, specifications and drawings requirements. 

 

 

Job Responsibilities: 

  • Assist with development of quality and operating systems to assure alignment with current GMP/QSR, and ISO requirements. Maintain and manage the Quality System Processes and ensure compliance to the required regulations.
  • Interface on an ongoing basis with customers to ensure requirements/concerns and complaints are communicated and corrective and preventive actions are closed in a timely and effective manner.
  • Management of customer documents ie Drawings; Purchase Specification; Quality Agreements etc. and the training out of relevant personnel.
  • Drafting and approving of quality documentation to meet Customer requirements ie Quality Specification Sheets (QSS), CAPA’s, Defect Library etc.
  • Managing and maintaining document and change control.
  • Trending and track of quality data to support quality improvements across the business
  • Lead investigations into material/product issues to ensure a thorough root cause, containment / corrective and preventive action is implemented.
  • Adherence to incoming control requirements and supporting the SCAR process when required.
  • Participate in the review of validation protocols and reports to ensure quality compliance.
  • Executing internal process and system audits.
  • Manage quality projects in support of continuous improvement eg. Lean Projects.
  • Co-ordinate activities associated with change management and customer interaction.
  • Ensuring the timely and effective closure of day-to-day quality issues.
  • Interface with other departments on a daily basis.
  • Batch paperwork review and final decision to release product for shipment
  • Analysing and reporting of key measures eg. Ppk’s, Cpk’s, Cost of Quality, Customer Complaints, and Internal/external quality results.
  • Interact with Operations and Quality management in the detection and resolution of quality problems. Determine and implement effective correction actions as required to avoid repeat non-conformances.
  • Develop and establish advanced quality systems and procedures, inspection plans, quality performance trends, statistical plans, cost estimates, and technical quality plans
  • Ensures that project and/or process control documentation is compliant with requirements and/or contract.
  • Represents company by interfacing with customers and regulatory agencies and assisting with internal and external audits as required.
  • Leads root cause analysis and corrective actions utilizing Quality tools such as “8D”, “5Y” to determine root cause(s) and to assess effectiveness of solutions
  • As required, oversee and performs inspections and applicable tests for assigned products
  • and processes to ensure accurate requirement implementation and fulfilment of contractual requirements.
  • Perform any other duties required or requested.

 

Minimum Qualifications/Requirements: 


 A bachelor’s degree in engineering or a related field and/or a combination of practical and educational experience in the medical device industry is required.

 Minimum of three (3) years’ experience in medical device quality assurance with a background of working in a regulated manufacturing environment.

 Experienced in Process Validation to Medical Device Regulatory requirements.

Ability to develop and write protocols, validation reports, engineering reports, etc.

Desired Characteristics/Desired Competencies: 

  • Certified Quality Engineer (CQE) strongly preferred.
  • Proficient in interpreting engineering drawings/blue prints.
  • Sound organizational and analytical skills
  • Capable of multi-tasking with sufficient ease to meet multiple priorities and deadlines.
  • Demonstrate effectiveness working across organizational levels
  • Familiar with the applications of medical device industry requirements of ISO9001, ISO13485
  • Capable of inspecting parts and familiar with standard inspection tools.
  • Strong interpersonal and leadership skills
  • Strong written and verbal communication skills.
  • Experience in Injection moulding desirable 
  • Experience in medical device assembly
  • Previous experience of quality in a company manufacturing medical devices. 
  • Proficient in use of computer applications including MS Office Suite, MS Project, Visio.