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Title:  Quality Technician, Quality Assurance

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:  Staff Engineer, Quality Assurance

 

 

PURPOSE OF POSITION:

This role functions primarily to support the Quality Assurance Department with Manufacturing Operations and New Product Development activities

QUALIFICATIONS

 

 

Required:

  • A minimum of four (4) years of previous Quality Assurance experience or a two (2)-year degree in Quality Assurance/Control are required. 
  • Good working knowledge of product and manufacturing processes within the plant. 
  • Ability to interpret drawings and specifications. 
  • Ability to communicate clearly with all levels of personnel. 
  • Proficient in all aspects of Quality Control/Assurance procedures and possess a detailed knowledge of product components and their impact on assembly and use of the finished product.
  • Level of Education/Knowledge needed: High School diploma or GED.

Preferred:

  • Desired Education/Knowledge
    • Knowledgeable of ISO13485 Quality Standard
    • Knowledge of FDA 21 CFR820 regulations
    • Knowledge of Enable Injection Quality policies
    • Knowledgeable of how Statistical Process Control (SPC) is applied

Skills & Competencies:

  • Proficient at reading and writing English
  • Ability to:
    • Work with others (interpersonal skills)
    • Give and receive feedback
    • Train others
    • Solve problems and make informed decisions
    • Plan and organize job tasks
    • Set priorities and timelines
    • Communicate (both verbally and in writing)
    • Break down tasks into their parts
    • Take initiative (see what needs to be done and then do it)
  • Proficiency using:
    • SAP
    • Microsoft Office including Word, Excel, MINITAB
    • Precision measuring instruments (Calipers, Micrometers, Comparator, Vision System, etc.)
    • Knowledge of Product specifications
    • Inspection methods and documentation
    • Basic Engineering print understanding
  • Write and execute protocols.  Write final reports

 

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:

  • General Functions
    • Support Manufacturing Operations through Operator proficiency assessments, Operator compliance to Quality system, Quality Alerts, Training, In process Audit Inspections, Specialty Quality Inspections, Manufacturing record review, Inspection guidance, etc.
    • Support Quality Department with assisting in data collection for metric reporting, Quality improvement projects, special audits, and development of inspection methods.
    • Assist New Product Development activities through process capability studies, equipment verification/validation activities, product verification/validation activities, process improvement activities, etc.
    • Support company corporate goals and objections, infrastructure goals and objectives, manufacturing goals and objectives, and Quality Management System goals and objectives.
  • Essential Functions
    • Report “out of control” conditions and assist operations in analysis and reaction procedure.
    • Investigate specific problem areas in manufacturing seeking to find root cause and report on findings or corrective actions required
    • Apply and interpret ANSI/ASQ Z1.4 and other sampling plans for predicting percent defective and lot acceptance criteria.
    • Train manufacturing personnel relative to inspection techniques and documentation of inspection results.
    • Participate in Operators training qualification by conducting an assessment of their competence for performing required inspections.
    • Conduct routine product audits, process audits, behavioral audits, review inspection techniques and documentation of results performed by manufacturing personnel.
    • Maintain those elements of the plant Quality System that pertain to the assigned area of responsibility
    • Assist Mfg. Quality Engineer with process changes, process performance studies, and/or verifications/validations as needed
    • Conduct DHR document review for completeness and compliance
    • Support verifications/validations/studies in measurement of product when business needs require.
    • Report directly to Mfg. Quality Engineer or QA Manager and have no supervision over others.
    • Support manufacturing environment monitoring activities and excursion activities.
  • Safety
    • Participate fully to achieve the company’s safety goals.
    • Maintain a clean and safe work environment.
    • Take responsibility for own safety.
    • Hold self-accountable to follow all safety policies & procedures
    • Debrief accidents & implement solutions to eliminate root cause.
    • Hold team members accountable to safety standards/regulations & policies.
  • Accountability:
    • Enable Injections has the following Core Values that are expected behavior from every employee:
    • Treat everyone in a respectful manner
    • Be accountable for your role in helping Enable achieve its business objectives
    • Positively influence the organization through your attitude and contributions
    • Incorporate listening and observing to communicate in a thoughtful, intelligent, and honest manner
    • Demonstrate your belief in the mission of the company

 

 

 

 

 

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