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Candidate will be responsible for assisting the QA Manager with quality planning inspection, method development, and defect prevention/corrective action processes for new and existing products as well as serve as a team member on Trauma Development projects and conduct quality system audits and assessment of internal manufacturing cells and supplier manufacturing sites as necessary. This individual will identify and recommend production and process issues, perform employee certifications, support various operation/manufacturing groups and suppliers in resolving and/or preventing quality issues.
In addition, a large part of the candidate’s responsibility will involve CAPA administration. This individual will be expected to participate in the implementation of the CAPA software solutions program and Administer CAPA. This will involve administrative duties including the monitoring of information relative to problem statements, root cause analysis, corrections, corrective and preventative actions. Candidate will provide communication to responsible individuals for timely completion and documentation of activities and serve as resident expert in CAPA regulatory/compliance. Further, this candidate will monitor the effectiveness of the CAPA system, and coordinate all needed training for users of the CAPA system.
Education/Experience:
Bachelor’s degree in engineering or an alternative Bachelor’s degree in the physical sciences.
2-5 years experience in a Quality Engineering field. Familiarity with good Manufacturing Practices and QSR/ISO regulations and good understanding of modern quality control/assurance techniques such as, inspection methods, statistical sampling plans, corrective/preventative action plans, first article layout, gauging concepts, FMEA, validation, and SPC. Expert knowledge an ability in blueprint reading and Geometric Dimensioning and Tolerancing and a good understanding of machine and manufacturing processes and capabilities.

QUALITY ASSURANCE
Job ID 108634
Position Type Full-Time Contract
Company Name MedFocus
Location Warsaw, IN
Salary Unspecified
Experience 2-5 Years Experience
Desired Education Level Bachelor of Science

Baxter International Inc. develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide. Conduct and write Corrective And Preventive Action (CAPA) investigations to determine the root/probable causes for nonconformities/out-of-specification events Facilitate meetings with subject matter eperts for the development of root/probable causes and corrective actions Manage and prioritize multiple CAPAs to ensure business needs and timeliness requirements are met or exceeded Assess CAPA execution and drive improvement and/or sustainability Ensure regulatory compliance of the quality system procedures relating to Product Holds, Field Corrective Actions and CAPA Applies state of the art techniques in the area of expertise to develop new or improved products and/or processes May lead a large scale program or several small projects with complex features Performs financial planning and assists in the analysis to justify project approval Independently plans, schedules and leads cross-functional team in detailed phases of the engineering work in a project May supervise one or more engineers or technicians Knowledge and understanding of CAPA system regulations and standards (e.g. ISO9001, ISO13485, FDA 21CFR) 3-5 years experience with CAPA Excellent technical writing and verbal skills Effective leadership and influencing skills Good team work and interpersonal skills Strong analytical and problem solving skills Excellent attention to detail Resourceful, self-reliant, self-motivated and confident Display a solid understanding of theories/practices utilized by other disciplines outside primary area of expertise Effectively operate in and may facilitate cross-functional teams with guidance Must have experience or advanced training and demonstrate proficiency (e.g. computer-aided design, total quality management, statistical methods, problem analysis and resolution, materials science, design of experiments, software development). Completely proficient in relevant products or process development processes. Successful track record of managing wide-ranging activities within the business unit. Recognized as a technical expert by peers and other personnel within the business unit. Extensive cross-functional team experience, including technical and non-technical work. Ability to organize and present technical and project management without assistance. BS in Engineering required MS in Engineering and 5-7 years (a plus) Demonstrated success in delivering results on several technical challenges.Baxter provides its employees with comprehensive compensation and benefits.To view other opportunities at Baxter and to learn more about the company, please visit our Web site at http://www.baxter.com/about_baxter/careers . EOE M/F/D/V.

Principal Engineer, CAPA Job in Round Lake 60073, Illinois US