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Spectrum Plastics Group, A DuPont Business · 13 hours ago

Quality Engineer II

Farmingdale, NJ

Full-time

Onsite

Mid, Senior Level

3+ years exp

Spectrum Plastics Group, a DuPont Business, is seeking a Quality Engineer II to support process improvements and ensure compliance with regulatory standards. The role involves managing quality system documents, conducting investigations, and collaborating with cross-functional teams to drive continual improvement in product quality.

ManufacturingMedical DevicePlastics and Rubber Manufacturing

H1B Sponsor Likely

Responsibilities

Follows all Quality System requirements and company procedures ensuring regulatory requirements are met in an ethical manner

Meets commitments on time with accuracy and attention to detail

Maintains current knowledge base of existing and emerging regulations, standards, or guidance documents

Develop validation and/or verification protocols for changes related to process improvements; execute validations/verifications and report on the conclusions to support process improvements

Quality Representative for process and software validations (may require writing, reviewing, executing, analyzing and/or reporting on test protocols)

Maintains a working knowledge of applicable statistical techniques for validation and process capability/performance purposes

Quality Representative for Risk Management Activities for existing products

Provide interpretive assistance, to all departments, regarding quality documents

Support training on Manufacturing and Quality System documents

Conduct customer complaint investigations, interface with customers to gather necessary details, determine root cause and implement corrective and preventive actions

Interface with Engineering to drive continual improvement on existing manufacturing processes

Quality Representative for Design Control Activities for existing product lines

Release documents via the change control process as necessary. Train others where required

Prepare quality related deliverables in a timely manner

Participate in CAPA root cause investigation and actions implementation

Implement ongoing quality improvement processes working with cross functional teams

Acts as a consultant for areas related to his/her expertise

Performs other related duties as assigned by management

Quality Representative for contract review activities on existing products

Provides support as the primary Quality representative for Notices of Change (NOCs), Notices of Activity (NOAs), and Nonconforming Material Reports (NCRs) related to existing products

Potential Quality System Process Owner for the following (but not limited to):

Non-conforming Reports (NCR)

Customer Complaints

Supplier Quality

Environmental Monitoring

Corrective and Preventive Actions (CAPA)

Internal Audits

Training

Qualification

ISO 13485 2016FDA QSRStatistical analysisLead Auditor certificationMechanical aptitudeData managementAnalytical skillsDependabilityQuality improvementWritten communicationProblem solvingCommunication skills

Required

3 to 8 years of relatable experience in a regulated industry is required

A Bachelor's degree in engineering or related discipline is required; it may substitute for some of the years of required experience and knowledge

Well-rounded knowledge of ISO 13485:2016 and FDA QSR

Strong root-cause investigator and problem solver within a manufacturing environment

Mechanical aptitude with manufacturing experience

Well-developed written and verbal communication skills. Ability to write and comprehend instructions, short correspondence, and memos

Must possess the ability to work semi-independently with little daily input from a manager

Experienced in statistical analysis

Certified Lead Auditor

Ability to solve practical problems and deal with a variety of concrete variables and ability to interpret a variety of instructions furnished in written and oral form

Well versed in data management and graphical presentation of data

Experienced with Microsoft Windows, Outlook, Word, Excel, Microsoft Project, etc. is required

Generate reports using data analysis, SPC analysis/tools, etc. and effectively communicate findings/proposals to various users in the organization

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)

Distribution of Different Job Fields Receiving Sponsorship

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Trends of Total Sponsorships

2024 (1)