Share this Job

 

 

 

 

Title:  Engineer II, Quality

Requisition Number: 
Description: 

 

Enable Injections is made up of a team passionate about working together to make people’s lives better. We develop, manufacture, and support the enFuse®, a platform of wearable infusion devices designed to enable subcutaneous self-administration of high-volume therapeutics. Enable employees are technology experts focused on an exceptional patient experience in collaboration with our biopharma partners.

 

SUPERVISOR’S TITLE:  Manager, Quality Engineering

 

 

PURPOSE OF POSITION:

Career-Development position within field.  Requires moderate skill sets and developing proficiency within discipline.  Conducts tasks and assignments as directed.  Contributes to team objectives and outcomes as guided.  Moderate supervision with some latitude for independent judgment.  Limited problem-solving responsibility while working under defined guidelines.

 

QUALIFICATIONS

 

 

Required:

  • Bachelor’s Degree in Engineering discipline; or,
  • Education/experience equivalent
  • Position typically requires 4 to 5 years of relevant experience or equivalent combination of experience and education

Preferred:

  • Quality Engineer Certification (CQE)

Skills & Competencies:

  • Risk Management Experience
  • Knowledgeable with device manufacturing systems and methods and statistical analysis techniques.
  • Possess a good balance of technical expertise, analytical thinking and communication skills for resolving issues internal and external to the organization.
  • Competent with word processing, spreadsheet and statistical analysis software packages (preferably Word, Excel and Minitab)

Physical Requirements:

  • Must be able to remain in a stationary position for extended periods of time
  • Ability to constantly operate a computer and other office equipment, such as printer, telephone, etc. 

 

RESPONSIBILITIES:

  • Design and implement test plans and audits for products to ensure product quality targets are met.
  • Component Quality assurance including Incoming Inspection, Criticality assessment, Sample Size Selection, Inspection Method determination and Validation, Inspection Equipment Selection, qualification, and validation, Gage R&R Studies, First Article Inspection requirements determination.
  • Final Inspection Method determination including Sampling Plans, Acceptance criteria, equipment selection, and Test Method Validation.
  • Support Process/Product Validations through Sample Size determination, Normality Testing and Data Analysis. Establish Statistical Process Monitoring & Control in production.
  • Support product development projects and teams as required.
  • Support investigations, bounding, root-cause investigation and corrective actions per the corrective and preventative action program.
  • Support trend analysis tools to report on operational performance, product quality and monitor the effectiveness of corrective actions related to deviations, internal audits, customer complaints, and supplier performance.
  • Support material review board activities per control of non-conforming materials; Interface with suppliers to improve incoming quality issues.
  • Proactively communicate project status to management.

 

 

 

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, disability status, protected veteran status or any other characteristic protected by law.  


Nearest Major Market: Cincinnati