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Zeus · 1 month ago

Cathx Site Quality Lead

San Jose, CA

Full-time

Onsite

Senior Level

$138K/yr - $165K/yr

7+ years exp

Zeus is a company focused on manufacturing quality and customer satisfaction. The Cathx Site Quality Lead is responsible for ensuring the effectiveness and continuous improvement of the manufacturing site, overseeing quality staff, and ensuring compliance with relevant regulations.

ManufacturingPlastics and Rubber Manufacturing

Comp. & Benefits

H1B Sponsor Likely

Responsibilities

Ensure the effectiveness and continuous improvement of the manufacturing site to ensure customer satisfaction and achieve the quality policy objectives

Provide daily oversight to the Quality staff at the manufacturing site with the exception of the Design assurance engineers

Ensure compliance with 21CFR820, ISO 13485, and EU MDR 2017/745 (the requirements) as applicable to CathX at the manufacturing site

Oversee the following activities at the site for on-time completion and compliance with requirements:

Inspection, measuring and testing

Nonconforming materials

Complaints and RMA

Corrective and preventive action

Gemba walks and LPA

Equipment and process validation

Facility maintenance

Environmental monitoring and testing

Serve as the person most responsible for quality at the manufacturing facility, in the capacity of Deputy Management Representative when the Director of Quality is not present

Support, compile, participate in and post monthly metrics and management reviews

Oversee the IQC/ Metrology lab and provide direction on priorities for the Quality assurance unit (IQC) at the facility. The activities of IQC include:

Receiving Inspection

First Article Inspection

Testing & metrology

Final Inspection

Nonconforming Materials

Lot history record review

Lot release preparation

Preventive maintenance

Calibration

Ensure the output of the manufacturing site IQC/ metrology lab meets Top Management KPI and quality policy objectives

Act as the primary audit contact for external audits at the direction of the Director of Quality

Respond to customer survey and self-assessment requests at the direction of the Director of Quality

Review quality agreements and no-change agreements from customers at the direction of the Director of Quality

Lead problem-solving initiatives and improvement activities as agreed with Top Management to resolve manufacturing site or systemic issues

Provide input to Sustaining Quality and Design Assurance engineers at the manufacturing site on best practices

Qualification

ISO 13485 2016 Lead AuditorSix Sigma Green/Black BeltRegulated medical device experienceLeadership trainingMinitab software proficiencyCustomer satisfaction commitmentCommunication skillsProblem-solving techniques

Required

BS/BA, or Engineering degree with a scientific or engineering emphasis required

Seven or more years of work experience in a regulated medical device environment

Previous experience managing and supervising engineers, technicians and inspectors

Preferred

Six sigma Green or Black Belt preferred

ISO 13485:2016 Lead Auditor certification preferred

Management and leadership training or certification is desired

Company

Zeus

Delivering dependable and innovative polymer solutions for over 50 years.

Founded in 1966

Orangeburg, South Carolina, USA

1001-5000 employees

http://www.zeusinc.com

H1B Sponsorship

Zeus has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

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Trends of Total Sponsorships

2023 (1)

2022 (1)