Quality Engineer - Sustaining Services at Plexus

Neenah, Wisconsin, United States

Apply Now

Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Aerospace/Defense, Healthcare/Life Sciences, IndustrialIndustries

Requirements

Expertise in determining non-conformance and customer complaints through containment, root cause analysis, corrective action, and audits
Knowledge of ensuring product compliance with customer specifications, industry standards, regulatory requirements, and Plexus standards
Ability to approve changes and deviations, including Engineering Change Orders (ECOs)
Experience leading development, deployment, and oversight of metrics for the Quality Management System (QMS)
Capability to lead creation and maintenance of Master Validation Plans and support validation documentation
Proficiency in supporting external customer audits, internal audits, QMS recertification, and surveillance audits
Skills in leading product-related Corrective and Preventive Action (CAPA) discussions and closures
Competence in monitoring manufacturing operations, addressing quality issues, providing quality alerts, and leading containment and purges

Responsibilities

Lead development, deployment, and oversight of metrics for the Quality Management System (QMS) at the site to ensure monitoring of process health and compliance
Ensure products comply with customer specifications, industry standards, regulatory requirements, and Plexus standards; ensure Assembly Build Instructions (ABIs) comply
Approve all changes and deviations from established guidance, including Engineering Change Orders (ECOs)
Lead creation and maintenance of Master Validation Plans (when required) and ensure compliance; support creation and execution of validation documents
Serve as Plexus lead for external customer audits and internal audit activities; support QMS recertification and surveillance audits
Lead product-related Corrective and Preventive Action (CAPA) discussions and closures
Ensure continuous quality compliance during manufacturing operations; monitor operations to address quality issues quickly, provide quality alerts, and lead containment and purges
Lead development of 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

Skills

Quality Engineering

Sustaining Engineering

Manufacturing Processes

Aerospace Systems

Healthcare Devices

Industrial Products

Plexus

Manufactures and repairs medical devices

About Plexus

Plexus Corp. offers engineering and manufacturing services tailored 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, while also minimizing quality issues. Plexus stands out by providing end-to-end solutions, utilizing tools like the Strategic Mitigation Action Response Tracker (SMART) to enhance supply chain efficiency. The company's goal is to deliver specialized, high-quality solutions that improve operational efficiency and reduce costs for their clients.

Oradea, RomaniaHeadquarters

1979Year Founded

IPOCompany Stage

Robotics & Automation, HealthcareIndustries

5,001-10,000Employees

Benefits

Professional and personal development

Plexus Global Mentor Program

Accessible Resources

Risks

Closure of Portland facility may indicate operational challenges affecting workforce stability.

Partnership with Simbe Robotics could strain resources if demand exceeds production capabilities.

Integration with Gate Web3 Wallet may expose Plexus to cybersecurity risks.

Differentiation

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.

Plexus's Strategic Mitigation Action Response Tracker aids in predictive risk management.

Upsides

Partnership with Simbe Robotics expands Plexus's role in the growing retail automation market.

Acquisition of a new office building suggests potential for expanded design and development services.

Collaboration with Arch Systems enhances Plexus's Industry 4.0 capabilities for better efficiency.

Land your dream remote job 3x faster with AI

Try Jobo Free