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. 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. Has primary responsibility for planning and implementing the positions key responsibilities as they apply to new product introduction.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Leads the development, modification, and maintenance of quality evaluation, control plans and other quality documents
- Creation and changes of Quality System Documents, local and customer owned
- Approve batch record documentation and revising of manufacturing processes.
- Leads Non-Conformace Investigations, disposition and approval
- Serves as Quality Representative in the Material Review Board forums
- Supports the Supplier Quality funtion leading the SCAR creation and follow up, Supplier File updates, Investigations and CAPAs
- Audits and self assess quality systems for deficiency identification and correction.
- Assists with managing Part Files that define statistical analysis requirements and any associated control limits, as needed, for SPC
- Assists in the process for ensuring that corrective actions (CAPA) are completed in accordance with relevant ISO requirements (ISO 9001 and ISO 13485), Jabil Advance Problem Solving methods, and that documentation is complete and compliant with requirements. May own CAPAs and serves as a Leader for the Corrective Action and Preventive Actions implementation.
- Serve as a Validation Owner. Responsible for the development, approval and execution of validation activities.
- Assists validation owners ensuring that the validation processes are completed in accordance with relevant ISO requirements (ISO 13485), CFR 21 Part 820 and local procedure requirements. Serves as an auditor for validation
- Leads the development and implementation of methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
- May lead the design and analysis of inspection and testing processes, mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine responsibility for, products or materials that do not meet required standards and specifications.
- May provide direction and mentoring to less experienced QA Engineers.
- Demonstrated competence in Quality Engineering body of knowledge.
- May manage the internal supplier third party and participate in FDA quality audits.
- Lead the Plan quality operation activities, assuring the correct execution of quality tests for product release.
- May supervise Quality Inspectors and Quality 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.
- May perform other duties and responsibilities as assigned.
- Advanced English level, written and spoken
- Experienced in Root Cause Investigation tools, CAPA system documentation, Technical and Compliance reports writing
- Proficiency in use of personal computers, Microsoft Office products (Excel, Word and PowerPoint) and e-mail skills required.
- Minitab application knowledge (desired)
- Availability to work remote 90% of the time
- Travel requirements: US or Global, up to 20%
EDUCATION & EXPERIENCE REQUIREMENTS
- BS degree or equivalent
- 6+ years of experience
- Or an equivalent combination of education, training or experience
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