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0-5 years of experience
[company name] has been the world leader in real-time, distributed software simulation for military applications. 17 out of 20 largest defense contractors in the world used MAK product at one point.
- Directed 4 small teams of domestic QA, offshore QA, release engineering, and documentation.
- As a key member of MAK’s engineering leadership team, participated in defining long-term technical roadmap and contributed to short-term product design, development, and release management.
- Managed and coordinated various quality related programs and projects. Some were internal and some collaborated with external partners and customers.
- Jump-started MAK’s quality assurance initiatives. Educated stockholders the value and importance of quality assurance especially as software vendor for many of the world largest defense contractors.
- Represented QA, release engineering, and documentation to communicate with rest of the company as well as existing and potential customers.
- Defined software QA and release process. Applied industry best practice such as Six Sigma concept to product development.
- Hiring, career development, and performance review for QA/Release/Documentation engineers.
- Maintained internal QA web portal. Researched software QA automation tools, defect tracking and feature management system.
- Participated hands-on QA test work whenever available, more of a ‘pinch-hitter’ role in baseball term.
0-5 years of experience
- Developed, implemented, and managed the Quality Management System for compounding facility that is patient specific.
- Lead the project of transitioning a facility from 503a to 503b compliance status.
- Managed a team of quality control and quality assurance personnel in bringing the company into compliance with current state and federal standards.
- Successfully initiated and completed product recalls at both sites.
- Interfaced with several regulatory agencies including boards of pharmacy and many regulatory arms of the FDA.
0-5 years of experience
Focus in Quality Management System process development and control. This lends to an Intimate knowledge of all facets of the organization due to heavy involvement with departmental processes from introduction to continual improvements. Currently oversee and control the corrective measures and monitoring systems within the organization such as non-conforming product, customer complaints, and audit corrective actions.
- Work with Executives to Create Strategy for Organization. Participate as Active Board Member.
- Project steering committee member helping to guiding the direction of global deployment.
- Oversee Regulatory Compliance for Product Development.
- Review and Implement Corrective Action for Manufacturing, Technical Support, and Innovation.
- Manage Projects for Engineering and Organization.
- ISO Quality Management System Process Owner and Developer.
- ISO 9001 Certified Auditor.
0-5 years of experience
Promoted from Program Coordinator to Director of Quality Assurance July 2012. Worked closely with the Executive Director on fundraising projects and special projects as assigned.
- I was the designated contact person for the agency with overall oversight of the agency as a whole reporting directly to the Executive Director. Coordinating internal and external program and service audits to ensure compliance and quality care for all individuals and prepared the agency for external compliance audits with monitoring agencies such as OHCQ and CMS.
- Established and maintained policies and procedures that are reviewed and approved by the Board and Executive Director, to ensure that programs met or exceeded internal and external consumer needs and expectations while fulfilling all obligations imposed by external oversight agencies; and developed and implemented quality assurance measurement tools.
- Prepared the Agency’s licensing and accreditation process to ensure compliance with state guidelines and prepared annual quality assurance reports for approval.
- Conducted detailed inspections of residential facilities in accordance to state DDA requirements to ensure quality of life for the Individuals served and recommended remediation strategies as needed.
- Managed the Agency’s incident reporting processes in compliance with DDA and COMAR regulations. Served as a “Rights Officer”, and was involved in completing major internal investigations along with law enforcement, Maryland Board of Nursing and Maryland Disability Law Center.
- Facilitated staff training during employee orientation and staff retraining on DDA Core approved materials and in accordance to state guidelines and regulations.
6-10 years of experience
Responsible for Quality and Regulatory compliance oversight of the Cellular Therapies, Therapeutic Apheresis, and Transplant Immunology Departments.
- Project leader for Quality Management System implementation (Document Control, Training, and Deviation modules). Implemented within project timeline.
- Improved tracking, closure and reduced errors of Quality Systems by using computer skills.
- QA oversight during all phases for two new clean room facilities.
- Trainer of all new employees on regulations related to cGMP and blood banking standards.
- Present lectures for the University of Cincinnati Cell Therapy and Blood Banking Master programs.
- Lead for FDA inspections of clinical trials and blood bank inspections.
- Lead multiple successful accreditation audits by FACT and AABB.
- Regulatory oversight for IND applications and correspondences to the FDA.
- Responsible for assigning goals, supervising, and annual performance review of QA Manager.
0-5 years of experience
- Build and manage cross-functional teams to enhance operational performance and reduce errors, working with technical and core service SME to establish operating policies and standards.
- Perform root-cause analysis and other problem solving activities to identify effective corrective actions and process improvements.
- Educate and train employees as to their impact in the quality management system.
- Guide the organization in development and use of KPI’s that support compliance and drive continuous improvement.
- Streamlined operations to improve customer response time through implementation of new client relations protocols, policies, and procedures.
- Ensure maintenance of QA records and audit document and quality control procedures, including internal QA audits for local, national, international, and legislation regulatory compliance.
- Lead or support APQP, DOS, Kaizen, Lean, Six Sigma, Black Belt, and ITS programs continuous improvement activities for control of failure modes and improvement of product quality.
0-5 years of experience
- Manage quality assurance team and processes across six national and international laboratory sites.
- Advise laboratory, donor coordination, and business development department heads on compliance related to regulations, procedures and requirements.
- Maintain AATB site certification for MedCure including audit preparation, audit response, and other compliance requirements.
- Optimize laboratory standard operating procedures, compliance, and shipping logistics.
0-5 years of experience
- Develop quality objectives, strategies, procedures, processes and corrective actions in conjunction with Engineering and Operations leadership.
- Maintain company QMS, ISO9100 certification activities and Internal Quality Audit program.
- Manage company Service & Repair activities – onsite and external contract repair center (Mexicali)
- Oversee multi-site CAPA program (RCA-CAPA problem solving utility).
0-5 years of experience
- Direct team of testers and developers
- Lead Readiness Review meetings
- Analyze requirement, (business, functional, technical and design), user stories and epics to create master test plans, scenarios, scripts and procedures
- Develop quality standards for company products, oversee the development and execution of software test plans and analysis of test results.
- Perform ongoing assessment of Quality Assurance and Testing processes and provide direction for continuous improvement.
- Prepare and release product testing documentation following successful testing and acceptance of a product release.
- Lead, review and document initiative for automation of test cases
- Prepare product and process quality reports by collecting, analyzing and summarizing information and trends
0-5 years of experience
I managed 30 interviewers in an outbound call center setting for the purpose of obtaining market research surveys.
- Conducted quality assurance coaching with each interviewer allowed me to improve their call
- Handled Quality Performance Reviews for all interviewers to ensure production expectations
- Corresponded with clients weekly to provide project updates and advise on completion dates.
- Ensured project completion goals were met in a timely manner and expected production rates
- Managed recruiting for client in-house focus groups and handled fielded intercept projects.
- Handled and documented as needed a variety of employee concerns on a daily basis including but not limited to schedule changes, HR concerns, and addressing company policy violations.
- Assisted in new-hire interviews, orientations and training. Assisted in terminations as needed.
- Upon termination of an employee, I processed final hours and handled corresponding
- Verified electronic time cards for payroll purposes. Made all necessary adjustments and corrections daily to ensure payroll amounts would be correct for payroll processing.
- Managed daily attendance records and counseled employees per attendance policies as needed with regards to absenteeism and tardiness.
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[Director Of Quality Assurance]
Last edited by: Gabriela Barcenas, CPRW, Content Writer II -
Gabriela Barcenas
CPRW, Content Writer IIGabriela is a Certified Professional Resume Writer (CPRW) and career adviser. With 10 years of digital media experience and five years of resume writing expertise, her publication history includes fashion, education, travel, social justice, equitable design and career advice.
