Europlaz Technologies is a leading contract medical device manufacturer

Europlaz Technologies leading contract medical device manufacturer

Quality Engineer - systems

 

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.

Role Summary/Purpose: 

As Quality Engineer at Europlaz Technologies you 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: 

  • Provide adequate oversight and control that assures all raw materials, component details and finished products supporting a given product are procured and/or manufactured in accordance with contractual quality requirements. Assist with development of quality and operating systems to assure alignment with current GMP/QSR, and ISO requirements.
  • As assigned, participate in new product transfers and be responsible for the development of quality plans, verification of engineering tests and measurement practices for new and existing products using QA Tools.
  • Active participation in the review of engineering specifications to assure that quality assurance requirements are met, and designs are successfully transferred into manufacturing.
  • Development of process controls using valid statistical techniques inclusive of SPC systems, sampling plans, correlation analysis etc.
  • Takes a leadership role in assuring all activities in the area of equipment and process validations meet FDA and EU regulatory requirements.
  • Development of IQ/OQ, Process Validation test protocols and reports to support product development and manufacturing process changes in compliance with customer’s control procedures.
  • Establish quality control criteria in terms of methods and procedures, visual and physical inspection points and testing requirements; surveillance over tools, fixtures, gages and tests; and prepare, approve and distribute various supporting quality documents, bulletins, and relative work instructions required to support assigned programs.
  • 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.
  • Provide input and approve manufacturing routings, insuring mandatory inspection points are adequately defined and appropriately placed.
  • Assess quality performance (or cost-of-quality) using statistical and analytical methods.
  • Devise and implement various complex methods and procedures for inspecting, testing, and evaluating the precision, reliability, and accuracy of products, processes, and production equipment.
  • 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.
  • Provides input on quality to product development teams; recommends producibility improvements by facilitating process reviews, addressing technical data packages, manufacturing methods, equipment, tooling and training.
  • 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
  • Experience in assembly
  • Previous manufacturing quality medical device experience
  • Proficient in use of computer applications including MS Office Suite, MS Project, Visio.

 

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.