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Marietta, GA  »   Jobs  »   Engineering  »  

Quality Engineer

  • Category: Engineering
  • Employment Length: contract
  • Source: Business
  • Ad #: 7122
Via: Apply / More Info
Full Details

TRC Professional Solutions, on behalf of the Client, is hiring for a Quality Engineer for a contract role (90 days) in the Greater Atlanta area.
This role will provide quality engineering support in the production of medical device products, and facilitate the application of production and process controls including continuous improvement. Provide quality engineering support to manufacturing sites and manufacturers when process changes are required.
- Actively support production through the application of risk management, production and process controls (including process validation), test method validation and quality engineering tools.
- Provide quality engineering expertise to maintain and improve product quality by investigating customer complaints, analyzing nonconforming material reports, partnering with Engineering, Operations and Service on design transfers and process validations and partnering with Supply Quality regarding supplier performance.
- Monitor quality metrics (e.g. field, manufacturing and inspection) and key process indicators to identify opportunities for improvement and partners with Operations, Service and Engineering to drive actions. Identifies unacceptable trends and applies suitable corrective action in order to meet strategic objectives.
- Review and approve process validation test plans, protocols and reports. Ensure validation results demonstrate compliance to medical device standards.
- Review test methods for quality of verification and validation of the method.
- Participate in product risk assessment efforts, including process failure mode effect analysis, within product teams and updates to existing product lines.
- Review and evaluate internal audit responses against current industry standards, regulations and guidelines to assure compliance. Drive closure of corrective and preventative actions to ensure implementation, compliance and continuing efficacy.
- Lead gap assessment audits and readiness inspections as needed.

Education and Experience:
- BS in an engineering discipline
- Working knowledge of the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive
- Skilled in statistical methods and design of experiments
- Manufacturing engineering or manufacturing quality engineering experiences a plus
- Certified Quality Engineer certification
- 8-10 years of engineering experience
- Working knowledge of production and process controls in a regulated industry
- Working knowledge of risk management for medical device products
- Experience with test methods and standards for the validation of manufacturing of medical device products
- Skilled in test plan development and root cause failure analysis
- Skilled in requirements analysis, including testable and measurable specifications
- Experience with test methods and standards for the validation of manufacturing and test methods for medical device products
- Skilled in test plan development and root cause failure analysis
- Skilled in quality engineering tools and disciplines such as process design, production and process controls, quantitative methods and tools, continuous improvement, etc. (e.g. Cost of Quality)
- Good verbal (including presentation) and written communication skills, especially technical report writing
- Ability to effectively work on project teams
- Ability to appropriately assess written design, process and device documentation as the principle advocate for compliance

Position Type/Expected Hours of Work
This is a full-time position. Days and hours of work are Monday through Friday; 8:00 a.m. to 5 p.m. Occasional evening and weekend work may be required as job duties demand.

This job operates in a warehouse setting. This role routinely uses standard manufacturing machinery. The noise level in the work environment is usually moderate.

This position requires no travel

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Map: Marietta, GA
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