Senior Quality Engineer - Space at Plexus

Neenah, Wisconsin, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Aerospace, Defense, SpaceIndustries

Requirements

Expertise in ensuring products comply with customer specifications, industry standards, regulatory requirements, and Plexus standards
Ability to ensure Assembly Build Instructions (ABIs) comply with specifications and standards
Capability to approve changes and deviations from established guidance, including Engineering Change Orders (ECOs)
Experience leading creation and maintenance of Master Validation Plans and ensuring compliance
Proficiency in supporting creation and execution of documents for New Product Introduction (NPI)
Skills to serve as Plexus lead for external customer audits and internal audit activities
Knowledge to support recertification and surveillance Quality Management System (QMS) audits
Leadership in product-related Corrective and Preventive Action (CAPA) discussions and closures
Technical training, leadership, guidance, and direction provision to regional and site management and stakeholders
Ability to ensure continuous quality compliance during manufacturing operations and monitor for quick issue resolution

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, such as complaints, disclosures, and inquiries
Engage Process and/or Product Engineers 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 requests
Provide feedback and documentation to the customer as required
Provide technical training, leadership, guidance, and direction to regional and site management and stakeholders
Ensure continuous quality compliance during manufacturing operations
Monitor ongoing manufacturing operations to ensure quality issues are quickly addressed and provide quality alerts

Skills

Quality Engineering

Aerospace Quality

Space Systems

Manufacturing Quality

AS9100

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.

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