Current openings at Facet Medical Technologies include:
The Quality Engineer plans and directs activities concerned with development, application, and maintenance of quality processes, materials, and products. Additionally, responsible for investigation manufacturing and customer nonconformance’s, determining root causes and corrective actions, reviewing and approving protocols and final reports and developing product specifications and sampling plans.
- Develops and initiates standards and methods for inspection, testing, and evaluation.
- Devises sampling procedures and designs and develops forms and instructions for recording, evaluating, and reporting quality and reliability data.
- Develops product specifications and sampling plans.
- Establishes program to evaluate precision and accuracy or production equipment and testing, measurement, and analytical equipment and facilities.
- Develops and implements methods and procedures for disposition and discrepant material and devises methods to assess cost and responsibility.
- Direct workers engaged in measuring and testing products and tabulating data concerning materials, product, or process quality and reliability.
- Develops, reviews and approves validation protocols and final reports for equipment, product, and processes.
- Resolution and continuous improvement for root causes analysis, including NCR and Compliance.
- Investigates manufacturing and customer non-conformances (complaints) through root cause analysis.
- Develops and implements corrective action necessary to resolve NCR/CAPA issues.
- Conducts effectivity checks for all root cause analysis, CAPAs and document findings.
- Formulates responses to customer complaints.
- Facilitates improvement projects and teams.
- Interacts with customers and suppliers routinely to ensure that product quality is constantly maintained. Addresses all product quality issues for current products. Oversees and maintains all quality functions related to packaging and manufacturing.
- Participates in FDA inspections, ISO audits, and customer audits of the plant quality system.
- Performs supplier and internal audits.
Skills and Experience:
- Minimum of 1-3 years Quality Engineering related experience and/or training is required.
- Knowledge of QSR, ISO 13485, CFR 820 and EN regulations.
- Knowledge of process improvement, SPC and other statistical process methods.
- Knowledge of process and product validations.
- 3-5 Years of Quality Engineering related experience.
- Experience in medical devices desired.
- Experience in product packaging desired.
- Experience in molding.
- Minimum if BS in Engineering, Science or related technical field.
Salary Range $73,000 – $77,000
Please submit your resume to email@example.com.