Full-Time

Quality Engineer Sr

Confirmed live in the last 24 hours

Plexus

Plexus

5,001-10,000 employees

Manufactures and repairs medical devices

Compensation Overview

$75.4k - $113k/yr

Senior

Appleton, WI, USA

Category
QA & Testing
Quality Assurance
Required Skills
Data Analysis
Requirements
  • Minimum of 5 years of related experience with a Bachelor’s degree required.
  • Ability to work well in fast-paced manufacturing environment.
  • Strong ability to identify and solve problems proactively using structured problem solving tools, including making timely and effective decisions.
  • Apply systemic data analysis and problem solving to address a full range of technical and organizational problems with creativity, imagination, confidence and responsibility.
  • Ability to design and conduct experiments, as well as to analyze, interpret, validate, and communicate data to key stakeholders.
Responsibilities
  • Serve as the primary customer contact for quality-related issues, including specification inquiries and audits.
  • Lead response and actions associated with customer quality concerns, including complaints, disclosures, and inquiries.
  • Engage the Process and/or Product Engineer and other Subject Matter Experts (SMEs) to address customer quality concerns.
  • Lead creation of customer defined quality reports.
  • Lead Corrective and Preventive Action (CAPA) development in response to customer request.
  • Provide technical training, leadership, guidance and direction to regional and site management and stakeholders.
  • Ensure continuous quality compliance during manufacturing operations.
  • Monitor on-going manufacturing operations to ensure quality issues are quickly addressed; provide quality alerts and lead containment and purges, when required.
  • Lead the development of the inspection strategy for receiving inspection, pre-ship inspection, and out-of-box-audits.
  • Ensure Certificates of Compliance are created and maintained, including documentation of deviations.
  • Ensure creation and maintenance of manufacturing quality history documentation, as required.
  • Yield customer Parts Per Million (PPM) to reduce Cost of Quality in order to deliver customer excellence and achieve Plexus’ enduring goals.
  • Lead analysis of quality metric data and identify opportunities to reduce scrap, rework and Clinical Risk Group (CRG)s.
  • Collaborate with the Process and/or Product Engineer to implement improvements.
  • Lead Corrective and Preventive Action (CAPA) development for repeat or systemic issues as well as ensuring implementation.
  • Provide support and leadership in order to effectively design, develop, monitor, maintain, and continuously improve the quality management system in alignment with Plexus strategies and values to ensure services are capable of meeting business needs.

Plexus Corp. specializes in engineering and manufacturing services for medical device manufacturers, focusing on aftermarket repair and maintenance for drug delivery devices. Their services lead to a 50% improvement in turnaround times and a 25% reduction in service costs. Plexus stands out by offering end-to-end solutions and utilizing tools like the Strategic Mitigation Action Response Tracker (SMART) to enhance efficiency and minimize risks. The company's goal is to provide high-quality, reliable services that meet the strict requirements of the healthcare industry.

Company Size

5,001-10,000

Company Stage

IPO

Headquarters

Oradea, Romania

Founded

1979

Simplify Jobs

Simplify's Take

What believers are saying

  • Partnership with Simbe Robotics boosts Plexus's role in the growing automation market.
  • Collaboration with Arch Systems enhances Plexus's data-driven manufacturing capabilities.
  • Recent investments indicate strong investor confidence in Plexus's growth potential.

What critics are saying

  • Closure of Portland facility may indicate operational challenges affecting stability.
  • Partnership with Simbe Robotics could strain resources if demand exceeds capacity.
  • Acquisition of new office space may increase costs without immediate revenue benefits.

What makes Plexus unique

  • Plexus offers end-to-end solutions from design to maintenance in multiple sectors.
  • The company specializes in aftermarket repair for medical devices, improving efficiency and cost-effectiveness.
  • Plexus employs advanced tools like SMART and SCORS for risk mitigation and supply chain optimization.

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Benefits

Professional and personal development

Plexus Global Mentor Program

Accessible Resources

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