Quality Engineer IV
SUMMARY
Leads the Workcell Quality Operations or NPI team, Quality Engineers, technicians and inspectors. Implements quality plans, programs, and procedures using quality control statistics, lean manufacturing concepts, and data analysis. Ensures that performance and product quality conform to the established company, customer and regulatory requirements. Reviews, analyzes and reports on quality discrepancies related to the assembly process. Leads investigation of problems and develops dispositions, modifications, and corrective actions for recurring or non-recurring discrepancies. Interfaces with manufacturing, engineering, customer, vendor and subcontractor representatives to ensure requirements are met.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
Leads the development, modification, and maintenance of quality evaluation and control plans and protocols for processing materials into partially finished or finished products.
Owns the development and implementation of methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
Provide support for all quoting activities by participating in the initial process design, development, and implementation phases.
Lead the plan quality operation activities, assuring the correct execution of quality tests for product release.
Approve batch record documentation and revising of manufacturing processes.
Serve as a Validation Owner. Responsible for the development, approval and execution of validation activities.
Support plant Quality System software validation as needed.
Assists validation owners ensuring that the validation processes are completed in accordance with the applicable ISO requirements (ISO 13485), CFR 21 Part 820 and local procedure requirements.
Leads the design and analysis of inspection and testing processes, mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost and determine responsibility for, products or materials that do not meet required standards and specifications.
Assists with managing Part Files that define statistical analysis requirements and any associated control limits, as needed, for SPC.
Audits quality systems for deficiency identification and correction.
Assists in the process for ensuring that corrective actions (CAPA) are completed in accordance with relevant ISO requirements (ISO 9001 and ISO 13485), Jabil Problem Solving methods, and that documentation is complete and compliant with requirements. May own CAPAs and serves as a leader for actions implementation.
May specialize in the areas of production control, product evaluation, reliability, and/or research and development as they apply to product or process quality.
Stablish clear measurable goals and objectives by which to determine individual and team results (i.e. operational metrics, results against project timelines, training documentation, attendance records, knowledge of operational roles and responsibilities, personal development goals).
May supervise, train or provide mentoring to less experienced QA Engineers.
Perform team member evaluations professionally and on time.
May manage the internal supplier third party and participate in FDA quality audits.
Recruit, interview and supervise Quality Engineers, Inspectors and Technicians.
Foster good morale, a proactive and positive culture, and maximize the opportunity for personal growth within the workcell QA Team Support all company safety and quality programs and initiatives.
Responsible for the generation / updating / maintenance the Matrix for the direct reports.
Comply and follow all procedures within the company security policy.
Provide support to all Safety, Health and Environment (EHS) programs and initiatives in order to support our zero accidents culture.
May perform other duties and responsibilities as assigned.
KNOWLEDGE REQUIREMENTS
Problem solving skills: Develop technical solutions to complex problems, which require the regular use of creativity.
Demonstrated effective negotiation skills and has the ability to work through obstacles.
Demonstrated high level of competence in the ASQ Quality Engineering body of knowledge.
Expert level in the use of Minitab and Quality Statistical tools.
Able to provide technical recommendations in topics with a high level of complexity.
MINIMUM REQUIREMENTS
Proficiency in use of personal computers, Microsoft Office products (Excel, Word and PowerPoint) and e-mail skills required.
Certified Quality Engineer preferred (ASQ CQE).
Bachelor’s degree required and seven years related experience; or equivalent combination of education and experience.
Must be proficient in English, both written and verbal.
Must have experience in the Medical Device industry and a strong understanding of ISO 13485 requirements and compliance.
Knowledge of PCBA (Printed Circuit Board Assembly) manufacturing processes and electronic components is preferred.
Jabil, including its subsidiaries, is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identity, age, disability, genetic information, veteran status, or any other characteristic protected by law.