Quality Engineer (Medical Device)

Roth Staffing is looking for a Quality Engineer for our client in Savannah, GA . This is an exciting opportunity to work for a global leader in life-saving medical device s with a strong corporate culture and competitive pay.

Job Description :

Summary : This position is responsible for developing and implementing systems to ensure products and / or services are design and produced to meet or exceed customer expectations and regulatory requirements including the US Food and Drug Administration, Health Canada, European MDD / MDR and others as required. This role will also participate in the implementation of the company's quality system processes related to complaint handling, process validation, internal nonconformities, product development and supplier quality to provide engineering analysis and

support in verification, validation and problem solving.

Core Responsibilities :

• Engages in continuous improvement activities by identifying opportunities and recommending improvements to product design and manufacturing processes. Provides ongoing quality engineering support throughout the product lifecycle, including risk management, design and manufacturing changes and CAPA investigations.
• Providing Quality Engineering subject matter expertise in authoring, reviewing, and approving Quality System documentation / NCMR material review board product dispositions / Engineering Change Control.
• Drives supplier quality improvement by providing engineering analysis related to component specifications and root cause analysis. Partners with key suppliers and manufacturing personnel to reduce defects and improve yield. Participates in supplier selection and qualification processes.
• Conduct periodic trend analysis and provides business impact analysis of product and process trends to monitor and take appropriate corrective / preventive actions to ensure product quality, patient safety and compliance with regulatory reporting requirements. Implements problem solving methodologies to reduce internal and external defects.
• Provide quality engineering insight and guidance on product development, product improvement and process improvement projects. Validates key design inputs including usability, reliability, performance, ability to manufacturer, safety and effectiveness.
• Plan, control and assure product and process quality in accordance with quality principles and best practices, including process planning, material control, acceptance sampling, measurement systems and process validation. Identifies and implements product and process controls consistent with the outcome of the risk management process.
• Author validation, verification and inspection assessments to ensure product test and manufacturing data support product release. Select appropriate tests and sampling sizes based on critical abiland statistical calculations.
• Maintains knowledge of relevant quality and regulatory standards and augments quality system processes to meet changing requirements, including the Medical Device Directive, Medical Device Regulation, US FDA, MDSAP and others as required.
• Conduct computer system validation and stay current with validation regulatory requirements.
• Participates in special projects and perform other duties as required.

Minimum Work Experience & Education :

General Skills & Competencies :

Specific Knowledge & Skills :

Travel / Working Conditions / Physical Demands :

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. For unincorporated Los Angeles county, to the extent our customers require a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.