Quality Assurance Manager Resume
Summary : An exceptional Senior Quality Assurance Manager who has over 7 years of experience in quality control, ability to handle quality assurance and quality of system compliance with the work, excellent time management skills to meet strict deadlines. Excellent written and verbal communication skills and committed dedication to continuous improvement initiatives. To work in an established company and apply all my knowledge and experience for the growth of the organization.
Skills : Good Manufacturing Practices, Quality Assurance, Quality Control, Pharmaceutical Industry, Cosmetic Industry, Regulatory Compliance, Regulatory Compliance, Quality Audits
- Introduced procedure models with a management style based on leadership and participation.
- Achieved that the improvement projects are part of the normal activity all the staff.
- Lead the definition, introduction, and suitability of the quality management that assures the introduction of the quality policy and the achievement of quality goals.
- Watched over, from the reception of raw material, until the shipping of our materials in order our products as processes comply with the rules of reference ISO:9001 and BRC, as well as with the regulations and food law.
- Proposed, together with the person responsible for the quality of the group preventive quality procedures for the product and quality system.
- Audited the quality system and BRC in order to guarantee its correct application and continuous improvement.
- Carried out internal audits and lead the external ones with the appropriate frequency.
- Asked the manager, commercial or technical that creates the claim, the compliance of the PGC-130, indicating if it is originated by the client or internally.
Bachelor Of Science
Technical Support/Quality Assurance Manager Resume
Headline : Technical Support/Quality Assurance Manager with 6 years working in the Biotech and Pharmaceutical Industries. Looking to obtain a position that can utilize my technical and leadership skills. Extensive experience ensuring quality in regulated manufacturing environments for medical devices and pharmaceutical products. Well-developed skills in both Quality Assurance and Quality Control systems working with regulatory agencies such as FDA, AVISA, and MHRA. Inherent ability to interpret and explain analytical technical documents, compendia requirements, and regulatory body documents.
Skills : Livelink, Trackwise, Phoenix, Athena, MFG/Pro-, STARMLIMS, EGate- Personal Performance Assessments, Merit Increases, Bonuses Microsoft Office -Access, Excel, PowerPoint, MS Word, And Visio
- Responsible for management of the following departments: QA supplier management group, QA incoming inspection group, QA particulate analysis group, and QA engineering group-sampling plans, quality technical agreements, risk analysis, process trending manager of higher or same level management/directors staff members.
- Reviewed and ensured that quality system processes and procedures were in compliance with all required standards and corporate policies.
- Provided leadership and training on the quality management system to direct managers and staff.
- Responsible for presenting and elaborating of all departmental procedures and associated documentation during FDA, MHRA, Anvisa, Canada, China, Japan regulatory audits.
- Led regulatory inspections, including tour of the facility, when senior management was not available.
- Transferred and implemented new material, chemical, and API incoming specifications.
- Presented metrics to senior management and colleagues on a quarterly basis.
- Coordinated validation activities with suppliers and validation department on various testing equipment such as Zwick material and component testing equipment and optical gagging product, smart scope multisensory dimension measuring system.
- Management of retain and reserve sample program including annual visual inspection for all drug product.
Master Of Arts
Corporate Quality Assurance Manager Resume
Summary : Extremely versatile Corporate Quality Assurance Manager experienced in Production/Warehousing/Logistics/Quality Assurance positions. Reliable in leadership roles and can be depended upon to accomplish any task. My objective is to obtain employment with a reputable company, wherein I can secure a busy and challenging position that will allow me to continue to work with the same integrity, dependability, and enthusiasm I am accustomed to.
Skills : Microsoft Word, 65 Wpm, Microsoft Excel, Windows 98/Office 2000, Data Entry/Ten-Key, PowerPoint, Basic Math, Basic English, Business Communications
- Performing regular internal facility audits utilizing state and company required audit tools with immediate notifications of results.
- Tracking all facility policy, procedure and contractual changes against the approved audit instrument, updating it as needed, as well as tracking all periodic quality assurance reports required by CCA's corporate office.
- Monitoring facility compliance to ensure zero tolerance towards all forms of sexual abuse and sexual harassment in preventing, detecting, and responding to such conduct in accordance with pre-federal guidelines.
- Ensuring the facility continues to run consistent with policy and procedure and contract requirements.
- Monitoring, tracking and making recommendations for all TDOC and CCA policy reviews.
- Thoroughly reviewing findings and assigning responsibility for correcting deficiencies noted in audits, tracking all audit deviations and corrective action plans for timeliness to review and comment prior to sending to senior managers.
- Making recommendations to department heads for policy and procedure changes that will increase the effectiveness and efficiency of the facility.
- Educating and train management staff on audit standards and practices, also to ensure an understanding of corrective actions plans from audit outcomes are monitored, measurable, specific and long term.
- Entering the required reports (audits, monthly security inspections, ACI health care outcome measures) into the Steton software program.
BS in Business
Regional Food Safety And Quality Assurance Manager Resume
Summary : Regional food safety and quality assurance manager with 7 years of food safety and quality experience. Development and implementation of QA/QC and regulatory compliance programs including evaluation, revision, and training. Collaboration with all departments including operations, sales, R&D in the execution of QA/QC and regulatory compliance programs to ensure production of safe, wholesome, and superior quality finished products. Ability to work independently with strong problem-solving, decision-making, and management. Effective oral and written communication. Ability to mentor and train others.
Skills : Management, Microsoft Office, Quality Assurance, Training & Development, Customer Service
- Responsible for QA/QC program development and execution management and supported the development and implementation of process and quality systems with respect to food safety, GMPs, SOPs, SSOPs, and HACCP.
- Assured compliance to all regulatory requirements, including local health dept., FDA, USDA, Silliker, and customer food safety audits.
- Conducted in-house plant inspections to assure compliance to all quality programs and processes.
- Maintained compliance with SSOPs including daily sanitation of processing rooms and equipment, pre-operational sanitation check, and operational sanitation programs.
- Collaborated with operations, product development, and sales for continuous improvement in the quality and reliability of the finished product in order to meet customer expectations.
- Participated in the development, evaluation, and revision of the plant's emergency response plan.
- Managed training, disciplinary actions, and annual reviews with a focus on talent development and performance management.
- Provided training to plant quality and operations teams on relevant topics: GMPs, SOPs, SSOPs, HACCP.
Ph.D. in Food Science
Senior Software Quality Assurance Manager Resume
Summary : Senior Software Quality Assurance Manager with a strong understanding of QA fundamentals, process improvements, problem-solving, and proven ability to lead technical teams. Proven leader with exceptional organization, communication, and relationships with a passion for quality. To obtain a job where my experience with problem-solving, quality control, continuous improvement, and problem management can be used to improve quality and profitability within a company.
- Overseeing a team of 8 engineers working in an agile environment.
- Enabling team success through advocacy, facilitation, and removing roadblocks.
- Monitoring the defect tracking system, assigning, and escalating defects as necessary.
- Communicating QA metrics, test results, concerns, and project status to the engineering management team and other stakeholders in a timely manner.
- Working closely with development, product management, and technical support to ensure that the quality objectives of all projects are met within schedule constraints.
- Creating each team members short and long term goals to allow them to succeed and progress.
- Recruiting, interviewing, hiring, and mentoring/coaching the quality assurance team members to meet business objectives.
- Exercising good planning and problem-solving skills while working in a fast-paced environment.
- Leading QA engineer group lead within the team, providing mentoring and acting as an escalation point.
- Acted as a positive change agent within a group that resulted in dramatically improved quality and customer satisfaction, rebuilding the customer's trust in our product.
Junior Quality Assurance Manager Resume
Objective : An experienced Junior Quality Assurance Manager with the ability to initiate/manage cross-functional teams and multi-disciplinary projects to meet organizational goals and objectives. Analytical thinking, decision making and problem-solving/ conflict resolution and strong quality assurance experience. Excellent personal communication excellent leadership and coaching project management: influencing, leading, negotiating and delegating abilities adaptability and tolerant to stressed situations.
Skills : ALM/QC, SQL, Microsoft Office, SDLC, Team Management, Meeting Facilitation, Foreign Exchange Processing, JIRA, PMUWS, Budget Management
- Developed, administered and maintained quality assurance procedures and activities required to ensure that the company's products conform to approved data and are in compliance with all FAA, company and customer requirements.
- Oversaw quality control and inspection procedures regarding the inspection, control, identification, and handling of parts from receipt to shipment.
- Responsible for ensuring a robust quality system and adequate resources for an efficient and effective program.
- Responsible for training employees in accordance with AS9100, customer and regulatory requirements.
- Assisted in the development of quality requirements in support of new product development including quality planning, test requirements, inspection methods, NDT methods, etc.
- Worked closely with engineering to ensure that final designs are developed with appropriate quality oversight to ensure final product conformance to engineering intent and all airworthiness requirements.
- Reviewed customer contractual requirements to ensure company compliance and correct and accurate implementation.
- Managed all aspects of quality issues that require customer interface, root cause analysis, corrective action and any coordination with regulatory entities.
Regional Quality Assurance Manager Resume
Objective : A motivated and qualified Quality Assurance Manager / Lead Engineer offering extensive experience in quality assurance, logistics, mechanics, training regulations, process implementation, problem-solving, and administration. A highly experienced and educated person offering over twenty-two years of effective managerial and logistics expertise. Dedicated, dependable, disciplined, and focused. Values hard work and am very meticulous in my proficiency. An experienced manager with excellent client and project management skills.
Skills : Microsoft Suite, Calibration Tools, Experienced In Microsoft Office Familiar With Excel, AS 400, And Powerpoint. Excellent Verbal And Written Communication
- Managed overall quality systems including quality engineering, quality inspection, NDI, calibration, DSQR, audits, and corrective action system and served as chief quality customer liaison.
- Managed the company's quality resources to reduce defects and improve overall quality measurement, to guarantee elicitation and completion of work prior to shipment of the winglet.
- Directed ISO, AS9100, NADCAP, and other quality compliance certifications required by customers and/or government agencies, and leads and participates in compliance audits.
- Communicated and corresponded with customers, suppliers, employees, and management within the company regarding quality issues, problems, and complaints.
- Managed quality audit program including external and internal audits, corrective actions and follow up.
- Ensured suppliers are adhering to purchase order and quality provision requirements.
- Organized meetings with suppliers to obtain cause and corrective actions reports as applicable.
- Identified and resolved manufacturing problems that affect the quality and assisted manufacturing and quality engineering personnel with the interpretation of complex part prints and specifications.
Branch Quality Assurance Manager Resume
Headline : Self-motivated and results-oriented Production Manager / Quality Assurance Manager with a proven track record of implementing and managing quality systems. Experience with regulated and non-regulated products from design to customer delivery. Respected by colleagues from all levels and functions in the organization for technical mastery and the ability to build effective cross-functional teams that deliver actionable systemic improvement plans.
Skills : Quality System Management, CGMP, ISO 17025, ICH, Auditing, Leadership, Team Building, Investigations, CAPAs
- Leading team of QA specialists to implement and manage quality assurance and food safety systems for three plants encompassing dry blends, liquids, spray dry and capsule operations.
- Providing QA training and coaching to the organization to support compliance with FDA regulations and SQF requirements.
- Leading cross-functional teams to resolve customer complaint issues by ensuring CAPAs are systemic in nature and eliminating the root cause.
- Leading internal auditing program and associated training to drive compliance with SOPs.
- Providing coaching to personnel for understanding and resolution of observations.
- Reviewing and approving proposed CAPAs to ensure delivery of robust systemic corrections.
- Implementing an electronic complaint portal and established system reporting metrics.
- Providing coaching to cross-functional teams on the complaints system, investigation techniques, root cause analysis and development of corrective and preventive action plans.
Bachelor Of Arts
Lab/Quality Assurance Manager Resume
Headline : As a Lab/Quality Assurance Manager, oversee the statutory and regulatory compliance and quality management system dedicated to achieving the highest level of customer satisfaction, product quality, and process reliability to meet customer requirements and continually return a positive customer experience. Achieved acceptance of quality management system (QMS) policies and procedures by Federal Regulators and DCMA. Managed QMS records control, document control, calibration, CAPA, root cause analysis and MRB processes.
Skills : Team Building, Supervision, Inspections, Risk Management, Proposals, Estimates, Design Reviews, Blueprints, Conflict Resolution, Project Records, Negotiated Costs
- Responsible for the quality management systems and QA personnel at eight Wabtec global services field locations in the U.S.
- Collected and reported the cost of poor quality metrics for analysis of scrap costs, rework costs, supplier reject costs and process improvement.
- Provided guidance and mentoring for nonconforming material and process corrective actions for root cause and preventative action planning and implementation.
- Addressed customer issued concerns for corrective and preventative actions.
- Developed and implemented a formal quality system manual that aligned and supported requirements defined by Wabtec global services corporate and by AAR M-1003.
- Implemented project management tools to assist in establishing effective communication of customer requirements to Wabtec global services personnel.
- Skills used project management skills for improving the internal communication of customer requirements.
- Developed and initiated programs and procedures to ensure product quality.
MS in Management
Quality Assurance Manager Resume
Headline : Site Quality Assurance Manager with 5 years of experience in Quality Assurance inspections that consistently exceed customer standards and specifications. Calibration and validations of equipment in functional, security, compatibility and user acceptance testing. Hardworking, flexible schedule with a willingness to work long hours, focused on meeting deadlines and exceeding expectations. Conducting testing systems and setting up in an extensive production working environment experience with clients and implementing standard quality assurance processes.
Skills : Experienced In Microsoft Office Familiar With Excel, AS 400, And Powerpoint. Excellent Verbal And Written Communication
- Discarded and rejected products, materials and equipment that did not meet specifications.
- Determined adjustment and certification methods, formulas, and measuring instruments required based on customer specification requirements are met to standards recorded inspection and test data such as weights, temperatures, grades, and quantities inspected and graded.
- Monitored production operations for compliance with specifications and promptly reported defects.
- Collected samples during production and tested randomly to determine in-process product quality.
- Presented clear, organized data in graphs, charts, tables, and written reports.
- Recorded defects and coordinated issue resolution with the development team and functional leads.
- Inspected and packaged products meticulously according to manufacturing specifications.
- Inspected outbound shipments and conducted random sampling to ensure product quality.
- Performed preliminary, in progress, hidden damage and final product inspections.