Sr Quality Systems Engineer at Plexus

Buffalo Grove, Illinois, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Aerospace, Defense, Healthcare, Life Sciences, IndustrialIndustries

Requirements

Typically requires a minimum of 5 years of related experience with a Bachelor’s degree; or 3 years and a Master’s degree; or equivalent work experience
A combination of education, experience, and time in field will be taken into consideration
Self-motivated with the ability to work independently

Responsibilities

Lead, manage and/or participate in internal and external audits for applicable market sectors including customer audits/visits, regulatory inspections and registrar/certification audits as requested, which may include creating and maintaining the internal audit schedule
Manage, support or coordinate Corrective and Preventive actions to ensure timely response, follow through, and appropriate reporting to management
Work on special projects as requested to improve Quality System related activities
Assist to establish regulatory guidelines and industrial standards in quality system and work with site quality managers to ensure compliance at sites/region
Remain abreast of new and ever-changing applicable quality system standards and regulatory requirements (e.g., ISO 9001, ISO 13485, AS 9100, Nadcap, ISO 14001, etc.)
Support the design and installation of the quality system
Direct interface with internal customers to clearly and concisely communicate quality system and regulatory requirements

Skills

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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