Quality Engineer Sr at Plexus

Kelso, Scotland, United Kingdom

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Manufacturing, Biotechnology, HealthcareIndustries

Requirements

Candidates should possess a minimum of 5 years of experience in quality engineering. A strong understanding of customer specifications, industry standards, and regulatory requirements is necessary. Experience with New Product Introduction (NPI) and Quality Management Systems (QMS) is preferred. Familiarity with Corrective and Preventive Action (CAPA) processes is also required.

Responsibilities

The Quality Engineer Sr will ensure product compliance with customer specifications, industry standards, and regulatory requirements. This includes approving changes and deviations, leading the creation and maintenance of Master Validation Plans, and supporting NPI documentation. They will serve as the primary customer contact for quality issues, lead responses to customer concerns, and develop customer-defined quality reports. Responsibilities also include providing technical training, ensuring manufacturing quality compliance, leading the development of inspection strategies, and creating Certificates of Compliance. The role involves analyzing quality metric data to reduce scrap and rework, leading CAPA development for systemic issues, and supporting the continuous improvement of the quality management system.

Skills

Quality Management System (QMS)

Corrective and Preventive Action (CAPA)

New Product Introduction (NPI)

Engineering Change Order (ECO)

Customer Audits

Regulatory Requirements

Industry Standards

Customer Specifications

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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