Who We Are

Ideal Background

• Excellent planning, leadership, and client relationship skills
• Excellent interpersonal communication and writing skills
• ASQ, CQT/CQE
• CMM/MicroVu Programming Experience
• Solidworks Modeling Software Experience
• Gage R&R, CpK/PpK studies,
• IQ, OQ, PQ validation/qualifications, DoE analysis… etc.
• Injection molding background
• Medical Device manufacturer background
• Experience using Minitab Software for SPC, DOE, etc.
• Experience with the following:
  • Various metrology equipment.
  • Microsoft Office suite
  • Statistical process control
  • Ability to read, write and speak English
• Experience within the medical device industry.
• Previous experience with lean manufacturing concepts

• Medium work: Exerting up to 50 pounds of force occasionally and/or a negligible amount of force constantly to move objects.
• Ability to work for extended periods sitting and looking at computer while completing repetitive motions to include substantial movements (motions) of the wrists, hands, and/or fingers.
• Close visual acuity to perform an activity such as preparing and analyzing data and figures; reviewing detailed information; viewing a computer terminal; and expansive reading.
• The ability to manage a number of projects at one time with frequent interruptions and tight deadlines.

What You'll Be Doing

• Participate in activities concerning the development, implementation and maintenance of quality standards for all programs.
• Develop validation protocols, with customer input, monitor execution, and develop completion reports for approval.
• Responsible for First Article Inspection, pFMEA and Risk Analysis, Capability Studies, and customer driven requirements for device programs, GR&R.
• Corrective Actions and Supplier Corrective Actions.
• Inspection of fixture design
• Quality Systems and Analysis:
  • Reviews new projects and sees to the following as applicable:
  • Identification of critical variables and attributes;
  • First article sampling and reporting;
  • Develops Inspection Instructions/Techniques
  • Statistical analysis if required;
  • SPC dimensional monitoring for production;
  • Identification of resources needed to meet or assess required quality;
  • Preparation for quality assurance of initial trial and subsequent production;
  • Identifies needed holding/locating devices for Measurement Analysis and Designs.
• Reviews existing production:
  • Applies, utilizes and updates SPC;
  • Identifies opportunities for improvement to process and product;
  • Provides applicable training;
  • Utilizes the CAPA and NCR systems to facilitate improvements.
  • Performs various analyses as assigned:
  • Identifies, quantifies, and monitors product and process quality;
  • Measures various other performance indicators;
• Reporting:
  • Prepares various reports as assigned.
  • Interfaces with customers:
  • Quality Planning, Non-Conforming Materials, Continuous Improvement, Weekly Meetings, Corrective/Preventive Actions, Audit Activities, etc.
  • Supports the ISO 13485 Business Management System through Internal Auditing.
  • Continuous Improvement:
  • Conducts investigation, root cause analysis and corrective actions;
  • Coordinates implementation of product and process improvements;
  • Monitors and expedites the closure of corrective/preventive actions resulting from customer complaints, safety issues, management review, non-conforming product and staff generated.
  • Conducts training as assigned;
  • Participates and Leads Lean Projects for waste elimination
• Standards:
  • Develops, maintains and updates Procedures, Work Instructions, and Forms
  • Perform other duties as assigned.

Hargrove Culture