Europlaz Technologies is a leading contract medical device manufacturer

Europlaz Technologies leading contract medical device manufacturer

Quality Engineer

Role Summary/Purpose:

As Production Quality Control Engineer at Europlaz Technologies, you will require strong technical and analytical background coupled with a thorough understanding of medical device manufacturing processes including 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. 

  • Establish processes and systems to reduce waste throughout the Company.
    • 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.
    • Project manage all New product introduction to manufacturing from a quality perspective.
    • Provide input and approve manufacturing routings, insuring mandatory inspection points are adequately defined and appropriately placed.
    • Serve as an active member of the Change Review Board and lead related activities such as failure analysis and corrective action investigations.
    • 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.
    • Refines and enhances products and processes by applying continuous improvement and key lean manufacturing/production principles and techniques to critical areas of production.
    Represents company by interfacing with customers and regulatory agencies and assisting with internal and external audits. May act as main contact in audit. Develops and coordinates corrective action procedures and plans.
    • May provide leadership to others in department. Acts as prime contact on high level projects. Establishes goals, objectives, and metrics required to complete projects. Trains and mentors less experienced employees.
    • Leads corrective actions utilizing methodologies (5 Whys) to determine root cause and prevent recurrence.
    • As required, oversee and performs inspections and applicable tests for assigned products
    and processes to ensure accurate requirement implementation and fulfillment of contractual requirements. Reviews and signs Engineering Change Notices (ECNs) and engineering drawings.
    • Approves work orders prior to release to ensure production operations and BOMs are properly documented.
    • Details purchase order quality clauses for applicable products for application within MRP system
  • Perform any other duties required or requested, including managing & leading direct reports

Minimum Qualifications/Requirements:

• B.A./B.S. degree, or the equivalent combination of education and experience.
• 8+ years manufacturing quality engineering experience
• 5+ years experience in a supervisory or lead position.
• Experience with Lean methodologies required.

Desired Characteristics/Desired Competencies:

  • Certified Quality Engineer (CQE) strongly preferred. 
  • Proficient in interpreting engineering drawings/blue prints. 
  • Sound organizational and analytical skills. 
  • Demonstrated strength in decision-making.
  • Capable of multi-tasking with sufficient ease to meet multiple priorities and deadlines.
  • Demonstrate effectiveness working across organizational levels. 
  • Ability to analyze and develop policies/procedures, to perform sound root cause analysis, and to perform process mapping. 
  • Proficient with manufacturing processes and controls 
  • 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 assembly
  • Experience working with plastics
  • Experience leading lean and continuous improvement team, including documentation and reporting to management. 
  • Previous manufacturing quality medical device experience 
  • Direct management /supervisory experience of quality associates (e.g. inspectors, QEs, etc.) 
  • Proficient use of MRP and industry quality systems 
  • 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.