Quality Engineer

Full-time 5 months ago
Employment Information

About Pacur:

Founded in 1979, Pacur is an ISO 9001 certified custom sheet extruder based in Oshkosh, Wisconsin, which specializes in the extrusion of light and heavy gauge polyester, co-polyester and polypropylene resins for a variety of applications and markets served. It is the leading supplier of extruded PETG sheet used principally to provide rigid, high-performance packaging for medical devices. Pacur has an additional business (Carolex) in Longué, France. Pacur has significant plans for growth driven by broadening its offering, meaningful innovation, sustainable products and globalization through organic investment and acquisitions. The company’s revenues in 2022 were $160 million. Pacur serves the following markets: Medical Packaging, Food Packaging, Print, Sustainable Packaging and Electronics.

About Gryphon:

Gryphon Investors (www.gryphoninvestors.com) is a leading private equity firm based in San Francisco. The firm is focused on profitably growing and competitively enhancing middle-market companies in partnership with experienced management. The firm has managed over $5.0 billion of equity investments and capital since 1997. Gryphon targets making equity investments of $50 million to $300 million in portfolio companies with enterprise values ranging from approximately $100 million to $600 million. Gryphon prioritizes investment opportunities where it can form strong partnerships with owners and executives to build leading companies, utilizing Gryphon’s capital, specialized professional resources, and operational expertise.

Job Objective:

Provide comprehensive problem solving and technical expertise in support of Pacur’s Quality Management System (QMS) to ensure our customers’ needs are met. Entails promoting continuous improvement, ensuring compliance to quality processes, and enabling a customer-quality centric environment.

Essential Duties:

· Develop and support external and internal Corrective / Preventive Action plans that demonstrate proper root cause analysis and sustainable improvements.

· Interface with customers on quality issues and improvements, facilitate audits, provide product regulatory reports and other applicable product-related information to customers as applicable.

· Manage applicable supplier quality aspects such as; supplier qualification/approval/monitoring, supplier quality audits, Supplier Corrective Action Requests (SCAR), supplier certifications and agreements.

· Provide statistical analysis in support of Quality Assurance efforts and improvements in the areas of defect trends, product returns, complaint summaries, product and process capabilities, etc.

· Prepare technical presentations for customers and internal stakeholders.

· Participate in development of part reviews, part specifications, control plans. Create and edit Pacur product specifications and packaging specifications as appropriate.

· Participate in Inspection and Test Equipment initiatives, including; cost analysis and purchasing of new QA equipment, lab equipment calibration and maintenance, conducting equipment validations/submitting validation reports, conducting Gauge Repeatability and Reproducibility studies, creating test and calibration methods and procedures

· Develop manufacturing process validation plans, execute, and write summary reports.

· Participate in the integration of Pacur legacy quality systems information into the ERP system.

· Knowledge of procedures, work instructions and associated forms and ability to develop them. Subject-matter-expert (SME) for designated areas of the QMS.

· Participate in internal QMS and process audits as requested.

· Conduct training for Production and QA personnel as requested.

· Lead Continuous Improvement projects

· Other activities as assigned

Minimum Qualifications:

Knowledge, skills and abilities:

· Experience with a QMS based on ISO9001 or ISO13485 (FDA QSR exposure is a plus)

· Ability to conduct problem-solving using formal problem-solving skills and statistical-based methods.

· Detail oriented and well-versed in statistical techniques. Proficiency with Minitab is a plus.

· High level of organizational and project management skills.

· Excellent communication skills (written, verbal and interpersonal).

· Projects a strong professional image and able to interact within all levels of the organization.

· Experience in manufacturing and quality process capabilities is highly desirable.

· Skilled in using Microsoft software tools (Excel, Word, PowerPoint, Project).

Education/Training Requirements:

· BS degree in Engineering, Science, Quality, or related field, or the equivalent in relevant work experience

· 3+ years of quality-related experience in a manufacturing environment

· Lean Six Sigma Green or Black Belt is a plus.

· Experience in Medical related field is a plus.

· Internal audit training/certification is a plus.

Physical Demands/Requirements:

· The physical requirements are representative of the essential functions of the job with or without reasonable accommodations. An employee in this position is required to regularly stand, sit and walk. In addition, this position requires considerable manual dexterity for use of computer keyboard and mouse. The employee may also be required to walk through the manufacturing plant and will therefore be exposed to moderate noise levels. Reasonable accommodation will be considered on a case-by-case basis.

Preferred Competencies:

· Customer Focus

· Critical Thinking

· Problem Solving

· Bias to Action

· Approachability

· Adaptable to Change.

Job Type: Full-time

Pay: $80,000.00 - $95,000.00 per year

Benefits:

  • 401(k)
  • Dental insurance
  • Health insurance
  • Life insurance
  • Paid time off
  • Vision insurance

Ability to Relocate:

  • Oshkosh, WI 54901: Relocate before starting work (Required)

Work Location: In person

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