Quality Engineer in Morrisville, NC with Greene Resources

Job Description

Job Number: 40276

Quality Engineer

Job Description:

We are seeking a Quality Engineer to work with a firm that specializes in biomedical robotics at their headquarter location in the RTP NC area. The Quality Engineer is responsible for activities associated with product support, product development processes and production and process controls globally. This position focuses primarily on supporting the product support teams from design transfer, manufacturing, and post-market activities ensuring the quality objectives are understood and achieved. The Quality Engineer shall ensure mechanical, electrical, and software systems used in development, manufacturing and as part of medical devices are established according to requirements. This will start out as a contract opportunity with the potential for long-term employment. Pay is dependent on experience.

Responsibilities:

• Contributes to product complaints investigations; works on complaints metrics, works on complaints risk assessments

• Supports product evaluation boards (company feedback collection system, coordinating data collection and metrics with other teams)

• Supports Design Control activities globally; assists in the development of design concepts, prototypes and product specifications as part of the development team

• Contributes to design and process verification and validation activities including definition and qualification of test methods, acceptance criteria and statistical principles. Assists in writing and reviewing protocols, reports, work instructions, and SOPs to support product and process development

• Supports risk management activities including creation and maintenance of risk management files by product and process.

• Acts as an internal auditor

• Participate in the continuous improvement of the quality engineering system.

• Contribute to cross-functional activities that support business goals

• Ensure compliance with company quality and regulatory policies, procedures, and practices through appropriate communication, training, and education of sound quality assurance and regulatory principles

Education Requirements:

• Bachelor's degree in engineering or other relevant discipline

Desired Background/Skills:

• 2+ years in a quality engineering role in the Medical Device field preferred but not required

• Previous exposure to Design Control is preferred

• ISO 13485 inspections and FDA inspections experience a plus

• Auditor certification is a plus

Qualifications:

• Proficiency in use of Excel for metrics

• Understanding of design control, disciplined product development processes, regulatory, and quality requirements.

• Solid understanding of approaches to work breakdown, prioritization, resource allocation, and problem solving

• Experience working in cross-functional teams

• Self-starter with the ability to work towards goals with little day-to-day supervision.

• Fluent in English both written and verbal

• Proficiency with MS Office tools

• Knowledge of the standards related to medical device manufacturing

Other Information:

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Greene Resources is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.