The Quality Engineer will provide quality assurance support to the product development team, resolving bugs, defects, and other potential issues and ensuring that products meet customer specifications.

Job Responsibilities

• Operate within Good Manufacturing Procedures (G.M.P) regulations and guidelines always in accordance with ISO13485.
• Comply with all Standard Operating Procedures (S.O.P’s)
• Comply with the requirements of the Quality Management System and relevant standards
• 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.
• Reviews and approves validation protocols and final reports for equipment, product, and processes.
• Resolution and continuous improvement for root causes analysis, including NCE and Compliance.
• Investigates manufacturing and customer non-conformance's (complaints) through root cause analysis.
• Develops and implements corrective action necessary to resolve NCE/CAPA issues.
• Conducts effectively 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.
• Other duties as assigned.

Required Skills/Abilities 

• Excellent verbal and written communication skills.
• Excellent organizational skills and attention to detail.
• Extensive knowledge of or the ability to quickly learn the organization’s production processes.
• Excellent interpersonal skills with ability to serve as a liaison with developers, project managers, and customer support.
• Strong analytical and problem-solving skills.
• Proficient with Microsoft Office Suite or related software.

Education and Experience

• B.S. in Engineering, Engineering Technology, Science is required. Or
• Minimum of 1-2 years Quality Engineering related experience and/or training is required.
• Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification is preferred.
• Experience in an FDA regulated environment is preferred.
• Corrective / preventive action (CAPA): 1 year preferred
• Knowledge of regulations and industry applicable standards (ISO 13485, FDA CFR820, GMP, ISO11135).
• Knowledge of process improvement and other statistical process methods.
• Knowledge of process and product validations.
• Experience in healthcare industry and/or manufacturing industry is desired

Physical Requirements

• Prolonged periods of sitting at a desk and working on a computer.
• Must be able to lift up to 35 pounds at times.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.