JOB SUMMARY
Develops and implements quality plans, programs, and procedures using quality control statistics, lean manufacturing concepts, and analyses. Ensures that performance and product quality conforms to established company, customer and regulatory requirements. Reviews, analyzes and reports on quality discrepancies related to assembly and process. Investigates problems and recommends disposition, modification 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
· Maintains quality evaluation and control plans and protocols for processing materials into finished products.
· Analyzes inspection and testing processes, mechanisms and equipment.
· Assists with managing Part Files that define statistical analysis requirements and any associated control limits, as needed, for Predisys SPC/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), Nypro Advance Problem Solving methods, and that documentation is complete and compliant with requirements.
· May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
· May assist in process validations/qualifications in accordance with Nypro and customer requirements.
· Assist with internal supplier third party and FDA quality audits as needed.
· May assist in support of plant Quality System software validation as needed.
· Support all company safety and quality programs and initiatives.
· May perform other duties and responsibilities as assigned.
JOB QUALIFICATIONS
KNOWLEDGE REQUIREMENTS
Degree or Diploma in Mechanical Engineering or a similar discipline and preferably 5 years in Medical Device Manufacturing.
Knowledge of Product Quality / Process Quality / Customer Quality
Well verse in ISO13485:2016, MDSAP and will be advantage with knowledge of the FDA inspection and requirements.
Mandarin fluency required to liaise with Mandarin-speaking stakeholders
Proficiency in use of personal computers, Microsoft Office products (Excel, Word and PowerPoint) and e-mail skills required.
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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.
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