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Spectrum Plastics Group, A DuPont Business · 15 hours ago

Quality Manager

Glens Falls, NY

Full-time

Onsite

Mid, Senior Level

3+ years exp

Spectrum Plastics Group, a DuPont Business, is seeking a Quality Manager to ensure compliance with regulatory requirements and maintain high-quality standards. The role involves managing quality assurance processes, leading audits, and collaborating with various departments to foster a quality-driven culture.

ManufacturingMedical DevicePlastics and Rubber Manufacturing

H1B Sponsor Likely

Responsibilities

Responsible for site regulatory compliance

Ensure maintenance and implementation of Quality Systems and training

Act in conjunction with Plant Manager as technical contact on quality-related issues

Address customer concerns, applying root-cause analysis and problem-solving skills

Aid in development of suppliers and implementation of Quality Systems Documentation including training documentation and providing appropriate training

Lead audits by Third-Party Registrars/Customers

Fully support and work with all departments to ensure quality standards are upheld

Provide leadership within the daily QA activities and promote a Quality culture throughout the facility

Support utilization of ISO and QMS systems cost-effectively

Utilize APQP/PPAP, process flow maps, FMEAs, control plans and measurement system evaluations to support Quality Standard requirements

Ensure Quality documentation is current with Corrective Actions (PFMEA, Control Plans, Flow Charts, etc)

Manage and report key Quality Performance Metrics

Work with other disciplines to ensure the integrity of an ISO Class 8 cleanroom

Promote company Core Values with key focus on Safety

Assist with other various duties as assigned by management

Qualification

ISO 9001 2015ISO 13485 2016Lead Auditor CertificationQuality Assurance ExperienceQuality Systems DocumentationRoot-Cause AnalysisManufacturing Processes KnowledgeAnalytical SkillsStrategic Planning SkillsMeasuring/Test Equipment KnowledgeSoftware Applications KnowledgeCommunication SkillsPresentation SkillsNegotiation Skills

Required

Must possess degree of Science or Business or similar, with 3-5 years' experience in Quality Assurance in a manufacturing environment

Must have a thorough understanding and working knowledge of ISO 9001:2015 and ISO 13485:2016 standards

Must be a certified Lead Auditor

Must have experience managing third party regulatory and customer audits

Must have thorough understanding of QA/QC theory, procedures and practices, including potential failure modes for company product lines

Must have basic understanding of manufacturing processes and operation systems

Must possess strong communication, presentation and analytical skills

Must have ability to negotiate and communicate successfully at all levels

Must possess strategic planning and development skills

Must have extensive knowledge of measuring/test equipment, gauging practices and capability of undertaking full GR&Rs

Must possess working knowledge of computers, software applications (at least: Word, Excel, Visio, Access and Outlook) and excellent reading/comprehension skills

Preferred

ISO Certification: 2 years

Quality Assurance: 3 years

Manufacturing: 3 years

Bachelor's

Company

Spectrum Plastics Group, A DuPont Business

Acquired in August 2023 by DuPont, Spectrum’s history spans over 60 years of applications expertise including precision extrusion, specialty injection molding, blown film extrusion and conversion, medical balloon fabrication, laser processing, additive manufacturing, and complex assembly of catheters and other devices.

Founded in 1961

Alpharetta, Georgia, USA

1001-5000 employees

https://www.spectrumplastics.com/

H1B Sponsorship

Spectrum Plastics Group, A DuPont Business 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)

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2024 (1)