Long term temporary assignment - W2 ONLY
NO C2C or 1099 available with this position
The Quality Engineer I is responsible for supporting the Quality Management Systems. The Quality Engineer I will ensure that the Regulations, Standards and Guidelines are complied with ensuring that finished devices will be safe and effective and otherwise in compliance with the Federal Food, Drug, and Cosmetic Act (the act).
Duties
- Works with area teams to implement continuous quality improvement programs which may include: vendor certification for ship to stock; design of experiments to identify and control process variables; quality systems improvement projects; and installation of statistical and non statistical process controls.
- Assists area teams to maintain applicable regulatory compliance which may include new hire orientation training, internal and external QSRs and CAPA.
- Leads the review, disposition, and corrective action activities associated with discrepant components, materials, sub-assemblies and finished products.
- May ensure that quality reporting (e.g. incoming and in-process quality trends; returns analysis, categorization and corrective action activity, etc.) is maintained and documented with the assigned team.
- Leads the review of standard and non-standard analysis evaluation of issues such as the internal audit program, CAPA, materials review and complaint analysis.
Qualifications & Requirements
- 0-2 years related experience preferred.
- Knowledge of statistics.
- Experience/knowledge of applicable standards and regulations preferred.
- Knowledge of statistical sampling, audit techniques and test methods preferred.
- Proficiency in Microsoft Office suite of products (Word, Excel, PowerPoint)
Quality and Health & Safety (HSE) responsibilities:
- Knows and adheres to the quality policy of the company and the quality-related procedures and instructions
- Reports any deviation in product or process, of which he/she becomes aware, to his/her manager or the Quality department
- Completes all necessary training in the area of Quality and GMP (Good Manufacturing Practice)
- Immediately reports any dissatisfaction or complaint which is brought to their attention from a customer or patient regarding a Smith & Nephew product (e.g. in terms of quality, durability, reliability, safety or performance) to the complaints department
- Complies with all health, safety and environmental policies, procedures and job hazard analyses applicable to specified job activities; including medical evaluations as required by job function
- Completes all required HSE training
