Click PDF icon for job description:
||PTI Engineered Plastics, Macomb, MI
|Years of Experience
||Minimum of two (2) years of Quality Engineering experience in plastic injection molding.
||Bachelor's Degree in an Engineering discipline, or in the absence of a Bachelor’s Degree, equivalent education and/or work experience, including a minimum of four (4) years of Quality Engineering experience in plastic injection molding, is required.
||Competitive wages, excellent benefits.
||The Quality Assurance Engineer provides quality engineering support to all internal business functions in the development, validation, and improvement of manufacturing processes to ensure resulting output meets customer specified requirements. The Quality Assurance Engineer will be expected to build relationships with several different functional groups and implement the controls necessary to assure product quality.
||• Participate in scheduled APQP meetings and activities.
• Work with APQP team members to develop Product Quality Plans, including:
o the identification of special product and process characteristics to be monitored, and the methods for controlling and monitoring,
o the clarification of standards of acceptability for all product and process characteristics, including methods of quantifying subjective data such as appearance items,
o the identification and acquisition of special measuring and test equipment,
o the preparation and approval of quality documents (e.g., Process Flow Diagrams, PFMEA’s, Control Plans, Inspection Instructions/Reports, etc.),
o the identification of statistical techniques required for establishing, controlling and verifying process capability and product characteristics,
o the identification of appropriate actions, including error/mistake proofing methodologies, needed to reduce or eliminate high risk failure modes.
• Prepare and submit part approval documentation (e.g., PPAP/FAI) in accordance with customer-specified requirements.
• Work with suppliers and subcontractors to ensure requirements for quality are clearly understood and can be met.
• Review and approval of supplier PPAP/FAI documentation.
• Responsible for effective communication and training of QA-related activities to manufacturing and quality employees.
• Provide feedback to the APQP team regarding the effectiveness of the product quality planning effort before, during and after product launch.
|Skills and Experience
• Thorough knowledge of APQP, FMEA, MSA, SPC and PPAP.
• Familiar with ISO 9001 or similar Quality Management Systems (QMS).
• Strong background with statistical techniques (ASQ Green Belt a plus).
• Excellent technical writing skills and the ability to communicate well (both written and verbal).
• Works with individuals across all levels of the organization, including management, customers, and suppliers.
• Reads and understand engineering drawings and specifications, including GD&T.
• Identifies key process variables affecting product quality.
• Meets deadlines and/or objectives as directed.
• Creatively and effectively challenge status quo when developing solutions.
• Proficient with Microsoft Office programs (Excel, Word and Outlook).
• ASQ Certified Quality Engineer (CQE) or Certified Quality Technician (CQT)
• Excellent knowledge of continuous improvement, PDCA, Six Sigma, Lean Manufacturing, Kaizen, 5S, Process Sign-Off (PSO), Run@Rate, Taguchi Methods, etc.
• Knowledge of Scientific Injection Molding and/or RJG’s injection molding process
• Experience in Medical Device Industry either with an OEM or a supplier
• Experience in IQ/OQ/PQ approach to Process Validation
• Knowledge of:
o ISO/TS 16949
o ISO 13485
o ISO 14971
o 21 CFR Part 820
o AS 9100
o AS 9102