Quality Engineer II at Plexus

Oradea, Bihor, Romania

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

ManufacturingIndustries

Requirements

Bachelor’s degree and a minimum of 2 years of related experience; or equivalent work experience (combination of education, experience, and time in field considered)
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
Ability to seek out best practices and apply them within assigned area
Ability to design a system or process to meet desired needs within realistic constraints such as economic, efficiency, repeatability, environmental, health, and safety (includes documentation and controls for long-term sustainability)
Ability to become a Subject Matter Expert for an assigned system or process
Ability to coach and mentor technicians and other support staff within assigned areas of expertise
Ability to operate effectively in a cross-functional team environment
Ability to effectively lead projects involving cross-functional team members
Ability to support operational teams in a manufacturing environment with required personal protective equipment

Responsibilities

Lead development, deployment, and oversight of metrics for the Quality Management System (QMS) at the site to ensure appropriate monitoring of the health and compliance of processes
Ensure products comply with customer specifications, industry standards, regulatory requirements, and Plexus standards
Ensure Assembly Build Instructions (ABIs) comply with specifications and standards
Approve all changes and deviations from established guidance, including Engineering Change Orders (ECOs)
Lead creation and maintenance of the Master Validation Plans (when required) and ensure compliance
Support creation and execution of documents for validation
Serve as the Plexus lead to support external customer audits and internal audit activities
Support recertification and surveillance of Quality Management System (QMS) audits
Lead product-related Corrective and Preventive Action (CAPA) discussion and closure
Ensure continuous quality compliance during manufacturing operations
Monitor ongoing 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
Build and embed Quality Awareness in Operations by ensuring effectiveness of training and inspections
Educate operators and production associates on quality and compliance procedures
Lead the determination of non-conformance and customer complaints through containment, root cause, corrective action, and audits
Ensure product compliance to customer specifications and industry standards

Skills

Quality Management System

QMS

CAPA

Root Cause Analysis

Corrective Action

Audits

Validation Plans

ECOs

Customer Audits

Receiving Inspection

Pre-ship Inspection

Certificates of Compliance

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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