About Talent

Quality Engineer

Job Locations US-MN-St Cloud
Req No.
2018-1677
Category
Medical Device
Type
Regular Full-Time

Overview

JOB PURPOSE:

This position is the primary Quality support role for lab operations. This Quality Engineer is an integral part of the lab structure to ensure the completion of KPI Directives in Production, Service and Quality for Native work is met, while in parallel supporting delivery of outsourced product from the various Sister Labs that meets their specifications and requirements. This position may include supervisory responsibility for Quality Technician(s), Trainer(s), and Product Auditor(s).

 

PRIMARY RESPONSIBILITIES:

 

Under the direction of the Lab Manager and support from the SR Manager of Group Quality this position will lead the Quality function in the lab by providing broad-based support for all key Quality activities and initiatives. This includes Quality Systems, Complaint Management, Continuous improvement projects, defect analysis, product auditing, compliance with all specifications and process and operational procedures.

 

  • Work closely with Lab Operations, Technical Staff, and other resources to optimize and maintain the USRx PO ISO Certification Quality System and associated processes. Optimize and maintain key components of a quality system baseline including, work instructions, quality procedures, standards, and controls. Ensure compliance with regulatory agency requirements including FDA.
  • Develop procedures for documentation, nonconformance reporting, corrective actions and internal audits. Ensure basic processes are in place including, specifications, inspection, testing, calibration and training. Primary accountability for quality system maintenance and monitoring, and advancing the system through continuous improvement once implemented.
  • Understand customer requirements and develop/ maintain complaint management process.
  • Interact with Commercial Team on customer complaint related topics (field agreements; customer complaint programs etc.)
  • Investigate quality complaints, returned goods and lab redos by gathering and analyzing data from operations and support areas and performing root cause analysis. This will include planning test matrixes and assisting with actual testing as required and recommending corrective actions.
  • Trained in use of Zeiss axioscope (high-level microscope) for conducting and reporting product defect analysis.
  • Prepare regular quality complaint and quality project updates using standardized format. Responsible for the leading of Root Cause Analysis and Problem Solving Process for Customer Returns and inner company breakage (QRQC); provide regular status report to Quality Management North America.
  • Work closely with Commercial Operations to visit customers on site and present root causes and corrections regarding existing concerns or claims.
  • Work closely with lab technical resources, MET, T & I and Group Quality support staff and US customer quality group to investigate quality problems, coordinate testing and qualifications of New Products and process improvements as needed through means of e.g. Q&V.
  • Manage the Case Management Tool for responsible site including the inputs, completeness and top issues. Supervise and direct activities of a Quality technician who assists in maintaining the Case Management function including inspection measurement, testing, and tabulating of quality and trend data. Coordinate and support the analysis of Customer Returns for Mass Manufacturing and / or Rx Labs in compliance with Global procedures.
  • Maintaining test / product quality level results database by coordinating quality-related data from operations and reporting quality and reliability data using statistical techniques.
  • Responsible for developing an ongoing product auditing and reporting program.
  • Analyzing defects and root causes with production engineering, on site quality and supply chain and   define short term and long term countermeasures. Responsible for the managing of the established audit programs including completing product, process and system.
  • Evaluate and estimate potential risks and give regular feedback to Lab Management and Quality Management North America; if necessary, escalate topic to Commercial Operations
  • Responsible for the leading of Root Cause Analysis and Problem Solving Process for internal quality issues including established KPIs.
  • Prepare a weekly quality report on site performance vs KPIs (Non-Quality Expense) and distribute to Rx Management and Quality Management.
  • Responsible for overseeing the training department and Trainer and developing / implementing a formalized Training program including tracking and scoring of skill progression for Lab employees
  • Lead / participate in various quality improvement projects in the lab for scrap or/and rework reduction based on Six Sigma approach.
  • Responsible for supporting the development, rollout and auditing, of the 5S program in the lab working closely with the Industrial Engineer.

QUALIFICATION REQUIREMENTS:

  • Bachelors or Technical Degree in a technology discipline or equivalent industry experience.
  • Six Sigma Green Belt or Black Belt certification is a plus.
  • Minimum of three years’ experience working in the optical / ophthalmic industry is a plus.
  • English speaking and writing is required
  • Strong analytical skills
  • Strong computer skills including Microsoft Office (MS Word, MS Excel, MS Powerpoint Presentation)
  • Must be able to communicate internally at all levels
  • Must be able to communicate externally with the customer
  • Must be a self-motivated individual with good organizational skills that can prioritize work depending on importance
  • Flexibility to travel
  • Must have experience with Quality Tools (8D, Ishikawa, 5 Why, SPC, Minitab)
  • Must be willing to travel up to 30% of the time.

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