Manager, Quality Assurance (Multiple Openings)

Quality leader for all fulfillment and kitting operations at the Lewisville site. Work cross-functionally with our Operations, Product Development, Supply Chain, and Customer. Support teams to ensure and maintain high quality within our medical devices. Responsible for conducting all QC inspections (incoming inspections, in-process inspections, and final inspections), leading, and executing on site quality systems such as Change Control, CAPA, Nonconformances, and Deviations, and assessing onsite expansion opportunities with Operations and Supply Chain functions. Build and lead an onsite quality team while also leading projects to maintain and improve quality. Collaborate with all levels, building partnerships to further the refinement of short and long-term Quality objectives. Lead all aspects of quality assurance at the manufacturing site. Execute all QC inspections (incoming inspections, in-process inspections, and final inspections) for fulfillment and kitting operations. Work closely with Operations and Manufacturing Engineering to ensure high quality in manufacturing processes. Establish and maintain calibration, preventive maintenance, and validation programs. Oversee and execute CAPA and Nonconformance processes for Operations Quality. Partner with R&D and Design Qualityteams as part of NPD launches, design changes, and design transfers Collaborate with Supplier Quality Engineering (SQE) on quality-related issues (e.g. SCARs) from suppliers Overseeand execute Material Review Board (MRB), including product disposition. Ensure robust processes are in place to detect nonconformances, including incoming inspection, in-process inspection, and final inspection. Assess risk in manufacturing processes using tools such as PFMEA. Provide leadership, guidance, and mentorship to direct reports, if applicable. Support customer complaint investigations, as required. Identify, measure, monitor, and improve (as necessary) Quality metrics. Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving Quality issues. Support internal and external audits. Contribute to company-wide initiatives and/or improvement projects. The role manages 1 Quality Assurance Specialist. Telecommuting: 100% Telecommuting.This position requires a Bachelor of Science in Biomedical Engineering, Biotechnology, or foreign equivalent. 7 years of experience as a Quality Engineer, Quality Engineering Supervisor, Quality Manager, Quality Control Analyst or other occupation involving quality in the medical device industry. Additionally, the applicant must have employment experience with: 1. Quality Management Systems including: 21 CFR 820, ISO 13485 or ISO14971; 2. Statistical Process Control (SPC) methodology including Minitab; 3. Root cause analysis investigation and its associated tools (5Whys, fishbone diagram, Pareto analysis, or Fault Tree analysis); 4. Gage R & R studies; 5. Continuous Improvement tools (A3, Value Stream Mapping, Kaizen events or Gemba walks); and 6. Process validation including Installation Qualifications, Operational Qualifications and Performance who are interested in this position should apply by emailing resume to , reference [Manager, Quality Assurance / _2024] or via Minimum Salary: Maximum Salary: Salary Unit: Yearly

Created: 2024-11-10