Quality Systems Engineer

Quality Systems Engineer, Fresenius USA Manufacturing, Inc., a Fresenius Medical Care NA company, Irving, Texas

Performs company-specific quality control and assurance processes and technological innovations and is responsible for quality initiatives and compliance objectives at our Irving, TX facility through the development of methods, procedures, validations and quality planning. Specific duties include:

• Applies company policies and procedures to participate in the development, review, and

improvement of the facility's Quality Plan and manufacturing processes.

• Participates in management of product Risk Management Files. Continually updates information.
• Utilizes current acceptable industry/FDA requirements to justify, write, and implement process validation and GMP procedures. This includes drafting, reviewing and/or assisting in the implementation of validation protocols, final validation reports, Quality System procedures, performance qualifications, and Engineering Change Orders (ECO).

• Maintains validation records and systems to keep ongoing process validations current and applicable to process.
• Performs plant investigations into product complaints and prepares reports for review by Quality Manager prior to submittal to Corporate Quality Systems. Assists in drafting Corporate Material Review Board (MRB) request to deviate, when appropriate, from current

corporate documents.

• Analyzes processes, work operations, quality records, complaints, and other sources of data to identify existing and/or potential causes of failures. Where failures and potential failures

are identified, investigates and assists in making recommendations necessary to correct and

prevent recurrence.

• Uses appropriate statistical methodology, such as CpK and trend analysis, to assist in analyzing or reviewing manufacturing, quality, and/or laboratory data for recurring problems or the detection of negative trend. When recurring problems and/or negative trends are identified, recommends corrective action for problem resolution.
• Reviews processing procedures in new and existing programs to assure enhanced quality and productivity while remaining in compliance with FDA/cGMP/QSR. Assists the Quality Systems and Production operations with compliance to QSR requirements.
• Participates in management of the plant metrology program to assure all appropriate tooling is available for inspection and test, and that all calibration activities are performed when due.
• Participates as a member of the facility's Audit Team in performing internal and external audits as required.
• Participates in product design control activities for new product lines. Conducts risk analysis (Fault Tree, FMEA, FMECA, HASAP or equivalent accepted methods) as part of design control for new and existing product lines to identify potential hazards associated with the device design under both normal and fault conditions.
• Has the authority to issue a STOP NOTICE to immediately stop production when a concern

regarding possible production, stocking, or shipping of discrepant assemblies or product

arises.

Requirements:

Position requires a Bachelor’s degree (or an equivalent foreign degree) in Chemistry, Pharmaceutical Chemistry, Biology or a closely related field and 2 years of experience as a Quality Analyst in the medical device or pharmaceutical field.  Must also have 2 years of experience (which can have been gained concurrently with the primary experience requirement above) working with the following:

• Process validation (IQ, OQ, PQ), analytical instrumentation, analytical chemistry and analytical laboratory methodologies;
• FDA regulatory requirements (ISO 13485: 2106 and 21 CFR Part 820) related to quality systems for medical devices including but not limited to the topics of product release, product status and identification requirements, and investigation of nonconforming product;
• Documentation control processes/requirements and performing revisions to process standard operating procedures as part of process improvements;
• Product Complaints, Nonconformance (NC), and Corrective Action Preventive Action (CAPA) investigations and use of root cause analysis tools;
• Participation in internal or external audits and/or regulatory inspections in either a backroom or host room capacity;
• Statistical and trend analysis (CpK, ANOVA, t-Test, control charts, and AQL/RQL) to determine areas of process improvement as well as provide statistical justifications for decisions and sample sizes; and
• Windchill PTC and Trackwise (QTRAK) platforms for document control and quality record documentation and storage and the SAP platform for management and review of product status.