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Spectrum Plastics Group, A DuPont Business · 1 day ago

Lead Quality Engineer

Pittsfield, MA

Full-time

Hybrid

Senior Level, Lead/Staff

3+ years exp

Spectrum Plastics Group, A DuPont Business is seeking a Lead Quality Engineer responsible for executing quality engineering activities and supervising the Quality Control inspection team. The role ensures that products meet internal specifications and regulatory standards while leading problem-solving efforts and managing QC operations.

ManufacturingMedical DevicePlastics and Rubber Manufacturing

H1B Sponsor Likely

Hiring Manager

Chris Winker

Responsibilities

Participate in validations (IQ/OQ/PQ) and process qualifications

Analyze quality data and generate reports on trends and improvements

Execute Gage R&R/test method validation

Perform risk analysis (FMEA) and process capability studies

Develop and maintain control plans and inspection plans

Lead root cause investigations and corrective/preventive actions (CAPA)

Lead and maintain change control efforts

Conduct layered process audits and support internal/external audits

Supervise day-to-day QC inspection activities across shifts

Provide training, coaching, and schedule for QC inspectors

Ensure proper use of measuring equipment and adherence to Good Documentation Practices (GDP)

Ensure timely review and disposition of nonconforming product

Drive compliance with procedures and standard work at the inspection level

Maintain equipment calibration compliance (including scheduling and quoting)

Perform employee annual reviews and individual management

Develop and maintain Quality Lab metrics / KPIs

Perform other duties as assigned

Qualification

Quality engineeringRegulatory knowledgeData analysisCAPA investigationsGD&T interpretationCMM programmingStatistical techniquesMicrosoft OfficeMinitabLeadership skillsInterpersonal skillsTime managementAttention to detail

Required

Bachelor's Degree or equivalent, or 3-5 years' related experience and/or training, or equivalent combination of education and experience in quality engineering in the medical industry

Knowledge of regulatory requirements and industry standards (e.g., FDA QSR, ISO 13485)

Strong understanding of quality management systems, material inspection techniques, and root cause analysis methodologies

Knowledge of GD&T print interpretation, CAD Models, Statistical technique and Software, Programming CMM's, Validation Activities (IQ, OQ, PQ), Cleanroom practices, Sampling Technique

Proficiency in data analysis and problem-solving tools (e.g., 8D, FMEA, Pareto analysis)

Experience leading or participating in CAPA investigations and resolution activities

Proficiency in problem-solving tools and techniques (e.g., 5 Whys, Fishbone diagram, DMAIC)

Above average math skills (sound knowledge in both statistics and calculus)

Ability to work with a high volume of documents in a fast-paced environment

Strong written, verbal, time management and interpersonal skills

Ability to communicate effectively with all levels of staff and management, both internal and external

Collaborate with cross-functional teams

Leadership skills and team player

Highly organized

Must have a strong attention to details

Strong Computer skills; Microsoft Office (Word, Excel) and Minitab

Must be able to lift up to 25 lbs

Must be able to sit or stand for long periods of time

Must be able to climb up and down stairs

Travel is required to support company initiatives

Preferred

Experience with programming and operation of Coordinate Measuring Machines (CMM), inspection of machine components, and performance of gage R&R studies

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)