Under the direction of the Sr Quality Engineer, the plastic injection molding quality engineer is responsible for customer care including corrective actions and NPI work. This role supports production quality and continuous improvement initiatives by utilizing knowledge of our customer requirements.

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Key Responsibilities:

• Corrective Actions
  • Leader of the corrective action process from start to finish, creating CARs, establishing the team and driving root cause analysis and corrective action.
  • Coordinates with customer on external sort activities by 3rd party or customer including providing sorting instructions and ensuring proper containment and certification activities are being followed
  • Responsible for customer required corrective action request submission and approvals.
• Quality Management System
  • Part of Internal Audit team to ensure conformity and continual improvement of the Quality Management System.
  • Participates and champions continual improvement projects.
• Manufacturing quality support
  • Attends customer meetings as required.
  • Lead customer audits as required.
  • Maintains and is responsible for customer scorecards and driving the improvement of score card performance.
  • Leads the internal non-conforming product process and drives containment, root cause and corrective action activities.
  • Evaluate and implement new metrology technology as requested.
• APQP support
  • Evaluate customer blueprints for feasibility and develop quality plans that meet customer expectations and aligns with the organization’s metrology strategies.
  • Create and maintain core documents (Process Flow, Control Plan, PFMEA)
  • Participate and evaluate Gage R&R, capability studies and other MSAs and assess feasibility of meeting internal and external requirements.
  • Participate in gage design and order gages as necessitated by the APQP process to ensure measurement consistency at PPAP and ongoing production.
  • Review measurement data reports with engineering to facilitate timely and accurate decision making for changes to mold steel and/or process conditions
  • Compile customer approval documentation including PPAP
  • Establish IMDS compliance as required.
  • Participate and lead certification body audits (Such as ISO audits, UL audits etc.) as required.

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Experience:

• 3+ years in quality within plastic injection molding environment.
• Working knowledge of plastic injection molded parts.
• Background in medical injection molding preferred.
• Internal Auditing a plus.

Skills:

• Ability to read blueprints and understand Geometric Dimensioning & Tolerancing (GD&T).
• Proficiency in Microsoft Office (Excel, Word, Outlook); familiarity with statistical software (Minitab) preferred.
• Working knowledge of Corrective action tools such as 8D, 5 why etc.
• Effective time and task management.
• Ability to work independently and in a team environment.
• Decision making and prioritization skills.
• Strong written, verbal, and interpersonal communication skills.
• Thorough knowledge of quality tools, such as DOE, root cause analysis, Gauge R&R, capability studies, and GMP.
• Thorough knowledge of inspection equipment and procedures.
• Demonstrated team leading, problem solving and project management skills.
• Thorough knowledge of ISO requirement.
• Skills in statistical analysis and technical writing.

Physical Requirements:

• Ability to lift up & carry up to 30 lbs occasionally.
• Comfortable working in a manufacturing environment.
• Requires frequent stationary position for extended periods sitting at computer or at measuring equipment.
• Ability to travel between facilities and to customer locations.