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Quality Engineer in Va
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Quality Engineer V

Modis Charlottesville, VA Full-Time
$115,500.00 (Careerbuilder est.)
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RESPONSIBILITIES:

• Develop and implement Risk Management File deliverables (e.g. Hazard Analysis, sFMEA, pFMEA, dFMEA, Risk Benefit Analysis report, etc.).

• Review and monitor maintenance of Device History Files and Risk Management Files according to established procedures.

• Lead a team through investigations, risk assessments and corrective actions of CAPAs.

• Lead Quality System improvement projects following the DMAIC methodology and project management.

• Lead Quality requirements within the design transfer, design control and improvement project teams.

• Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies.

• Support the change control process by reviewing proposed changes, performing risk assessments, and assessing the adequacy of verifications and validations.

• Provide resolution of quality issues identified by production and project teams in accordance with established procedures.

• Lead Quality requirements within the design transfer, design control and improvement project teams.

• Support modification, continual improvement and maintenance of the existing Quality System

• Perform gap assessment and Implement Corporate Policy requirements under the Quality system

• Support the Supplier Management process ensuring proper conduct for supplier evaluation, qualification and monitoring.

• Perform first and last article inspection as well as in process inspection based on AQL sampling.

• Carries out duties in compliance with established business policies

• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.

• Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.

• Other duties as assigned, according to the changing needs of the business.

MINIMUM QUALIFICATIONS | EDUCATION/EXPERIENCE:

• B.S. degree; with a minimum of +6 years of related experience in Quality Engineering.

PREFERRED QUALIFICATIONS:

• Experience with root cause analysis, design control, design transfer, Risk Management, and validation activities.

• ASQ Certified Quality Engineer certification.

• Analytical/Problem Solving Skills (e.g. DMAIC, statistical techniques, risk analysis, engineering analysis)

• Writing and Communication Skills (e.g. write technical reports, present data analysis)

• Interpersonal Skills

• Service Orientation

• Working experience of FDA’s 21 CFR Part 820 Quality System Regulation, ISO 13485:2016 Medical Devices, and ISO 14971:2012 Risk Management.

• Working experience of regulations relating to in-vitro diagnostic medical device products and software (e.g. FDA’s “General Principles of Software Validation” and “Guidance for the Content of Premarket Submission for Software Contained in Medical Devices”, 21CFR Part 11, IEC 60601, IEC 62304).

• Knowledge of regulatory submissions process.

• Experience in Software Development Life Cycle activities and understanding of software design inputs and outputs.

• Working knowledge of product software, analytical process software, manufacturing process software and quality system software validation methods and requirements
.

COMPETENCIES:

• Communicates a clear roadmap and strategies for his/her organization or function.

• Spots new trends, potential problems and opportunities early and thus, able to develop creative solutions.

• Avoids getting stuck in a "one right way" approach – remains open minded to new ideas.

• Establishes function or organization goals linked to enterprise-wide priorities.

• Encourages and integrates the best ideas from many varied voices.

• Adopts a global mindset when making decisions.


Recommended skills

Iso 13485
Iso 14971
Quality Management Systems
Change Control
Title 21 Of The Code Of Federal Regulations
Validations

Location

CareerBuilder Estimated Salary What is the Careerbuilder Estimated Salary? Only about 20% of the jobs in our search results contain salary information. When a job posting doesn’t include a salary, we estimate it by looking at similar jobs in the same industry in that location. It is not necessarily endorsed by the employer and actual compensation may vary based on your experience.

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What is the Careerbuilder Estimated Salary?

Only about 20% of the jobs in our search results contain salary information. When a job posting doesn’t include a salary, we estimate it by looking at similar jobs in the same industry in that location. It is not necessarily endorsed by the employer and actual compensation may vary based on your experience.
This estimation is based on Job title, Industry, Location and Skills
$115,500
Avg. Yearly Salary
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