Quality Engineer

Quality Engineer

Location: Phoenix, AZ

Salary: $70,000-$100,000

Job Description

The Quality Engineer works closely with cross-functional representatives from all departments within the company, planning, coordinating, and executing the qualification and maintenance of processes, systems and equipment used in the manufacturing, packaging, testing, storage, and shipment of cadaveric, placenta derived and other specialty tissue allografts for the biomedical industry. The Quality Engineer will write and coordinate the execution of equipment verification and qualification protocols, temperature mapping protocols, shipping validation protocols, qualification and validation protocols and summary reports, package and packaging validation protocols and summary reports, standard operating procedures, controlled forms, deviations, investigations, and corrective and preventive action reports as assigned. The Quality Engineer will be able to work independently with general direction.

Education and Work Experience Requirements

B.S. degree in a scientific and/or engineering discipline (Chemistry, Biology, Physics, Biomedical Engineering/Chemical Engineering, etc.) Minimum of 5 years of quality engineering experience in a regulated environment within a pharmaceutical, medical device, biologic, tissue bank, diagnostic, hospital, or similar organization Minimum of 3 –5 years of experience participating in equipment qualification and process validation protocols and reports, and executing validation protocols Experience in applying statistical methods for quality improvements Experience in design control and process validation, root cause analysis, corrective and preventive action (CAPA) Experience with packaging and sterilization validation preferred

Essential Duties and Responsibilities

Develops, modifies, applies, and maintains quality evaluation and control systems and protocols for processing materials into partially finished or finished materials product. Maintain Quality metrics in databases and prepare trends and graphs as needed Facilitate QC equipment qualifications, quality process optimization, and quality test method validations Actively support Product Development and Manufacturing Engineering projects and validations Review and approve Product Development and Manufacturing Engineering validation protocols and summary reports Responsible for establishing, validating, and implementing QC test method SOPs Participate in internal and external quality audits Develop, execute, and analyze quality-reporting measures Serve as a resource to management and internal departments for problem identification and resolution Design and implement methods for process control, process improvement, testing, and inspection Create and monitor re-validation schedules Experience supporting nonconformance investigations, CAPA, and change control programs. Writes and updates assigned policies, procedures, forms and related documentation, using established document change control processes, and provides training in areas where they are the subject matter expert. Confers with management, production, or marketing staff to discuss project specifications or procedures. Performs any other work-related duties as assigned by supervisor and/or executive management.

Knowledge, Skills, and Abilities Required

Serve as Subject Matter Expert (SME) for all verification and validation activities Develop and oversee verification protocols to verify engineering specifications Develop and oversee validation protocols to validate customer requirements Analyze verification and validation test data Hands on application of Statistical Analysis Document test protocols and reports Test Implementation, Verification & Validation, and Risk Assessment Root Cause Analysis, Development of Corrective Actions Working knowledge of FDA regulatory requirements and all internal quality standards Highly capable of independent and critical thought and action

Physical Environment & Working Conditions

Full Time position (40 hours or more) based in Arizona, with the opportunity for hybrid structure once candidate has become established. Normal hours may include office work, lab work and exposure to sterile environment. Some duties may be performed in aseptic cleanrooms/areas, wearing prescribed PPE, standing for extended periods of time, bending, lifting loads up to 40 pounds, or more with material handling tools, minimal contact with body fluids, which may be considered infectious, to be avoided at all possible times. Such fluids may be present on records received; however, such records should be placed in a plastic sheet for protection.

Equipment & Machines Used Processing or facilities equipment such as autoclaves, lyophilizers, centrifuges, heat sealers, shaker tables, ultra-low temperature freezers, reagent refrigerators, incubators, sonicators, calipers, gauge blocks, residual moisture analyzers, laminar flow hoods, ISO certified cleanrooms and clean areas, pH meters, and other related equipment. Desktop/laptop computer and general office equipment and software such as MS Office, Word, Excel, PowerPoint, Project and Visio.

Confidentiality Requirement

The Quality Engineer is expected to maintain confidentiality of all donor/recipient information.