Compliance Software Quality Engineer in Orlando, FL at Consultis

Date Posted: 1/27/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Orlando, FL
  • Job Type:
    QA/Testing
  • Experience:
    Not Specified
  • Date Posted:
    1/27/2018
  • Job ID:
    76572

Job Description

Consultis

Compliance Software Quality Engineer

Job Description

Experienced Compliance Software Quality Engineer is needed for a Direct Hire position! At Consultis, for over 30 years, we have built long lasting relationships with our dynamic IT clients by crafting customized IT workforce solutions. We pride ourselves on the long-term relationships we have forged with our clients and our valued team members. We are looking for a Compliance Software Quality Engineer to partner with our client in Orlando, FL for a Direct Hire opportunity.

“Excellent company to work for…lots of training and support.” - Current Employee (www.glassdoor.com)

We are thankful to have such a talented group of technology professionals working with Consultis, and we would love to have more technology experts, like you, on our Consultis team! If you are looking for an opportunity to continue building your IT career, and you meet our qualifications, we want to talk to you!

Compliance Software Quality Engineer

Job Overview:

The ideal applicant will have a passion for learning, solving problems, developing new skills in yourself and others, and adapting to change in a successful start-up style atmosphere. You are able to hold yourself accountable on deliverables & commitments with minimal supervision. You can communicate with internal and external stakeholders on quality compliance issues with ease.

This is a medical device software quality engineer and compliance position and not a software QA tester position

Essential Job Functions:

  • Provide quality oversight and guidance to project teams by assuring that Quality Engineering principles are utilized to develop and enhance products that are robust, safe and effective
  • Ensure compliance to applicable policy, procedures and regulations
  • Provide direction and critical reviews for Development Planning, Design Inputs and Outputs, Design verification and Validation, Peer Technical and Design Reviews, Risk Management and Labeling review
  • Interface with external partners to transfer new and improved products
  • Provide training / guidance to project personnel regarding Quality including the appropriate application of design, statistical and analytical tools; including validation support using tools such as FMEA, DFMEA, PFMEA, IQ, OQ, PQ, control plans, process verification/validation plans, Cpk, Cp, SPC, DOE, process data analysis, and DMAIC.
  • Lead product corrective and preventive action related activities as appropriate
  • Identify areas for improving regulatory compliance and continuous improvement opportunities for products and processes
  • Represent quality at project meetings and provide quality guidance to project management
  • Write, revise, and review desk level procedures. Ensure quality and consistency in documentation and adherence to SOPs
  • Review and provide guidance for nonconformance reports. Assist with nonconformance analysis, risk assessment, monitoring, trending, closure, and process enhancement
  • Develop risk files for assigned product(s) and work with Dev and Manufacturing to collectively identify, analysis, estimate, and reduce risks to patient safety
  • Maintain expertise in quality systems (e.g. ISO, QSR, IEC)
  • Assist with continuous improvement initiatives / projects
  • Participate in internal or external audits and respond to audit observations as needed
  • Compile and institute quality metrics to present at review meetings to trend, recommend, and implement corrective actions and appropriate follow-up, when necessary.
  • Assist department supervisors with work load/activity scheduling
  • Perform other duties as assigned

Compliance Software Quality Engineer

Education and Qualifications:

  • Bachelor’s Degree in Software Engineering or related field
  • 3+ years’ experience in software quality
  • Knowledge of FDA QSR requirements.
  • Knowledge of ISO 13485 and other recognized international quality system standards.
  • Able to read, analyze, and interpret technical procedures and governmental regulations.
  • Able to write technical reports, business correspondence, technical procedures, as well as, administrative procedures.
  • Able to present proposals, data, and issues to company personnel at all levels.
  • Able to independently determine and develop an approach to a wide range of issues and problems. Solutions must be thorough, practical, and consistent with organization objectives.

Able to determine and develop technical solutions to a wide range of difficult problems.

Benefits

At Consultis, we are proud to offer an attractive employment benefits package to our consultants. As a full-time employee, you will be eligible for the following benefits:

  • Medical/Prescription Insurance – Consultis subsidizes the cost of employee-only coverage and employees can cover dependents via pre-tax payroll deductions
  • 401(k) retirement savings plan
  • Paid Holidays
  • Paid Vacation
  • Referral Bonus
  • Direct Deposit

Compliance Software Quality Engineer

 “Your Success is Our Success!