Quality Assurance Manager Resume Samples

Description :

1. Introduced procedure models with a management style based on leadership and participation.
2. Achieved that the improvement projects are part of the normal activity all the staff.
3. Lead the definition, introduction, and suitability of the quality management that assures the introduction of the quality policy and the achievement of quality goals.
4. 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.
5. Proposed, together with the person responsible for the quality of the group preventive quality procedures for the product and quality system.
6. Audited the quality system and BRC in order to guarantee its correct application and continuous improvement.
7. Carried out internal audits and lead the external ones with the appropriate frequency.
8. 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.

Experience

7-10 Years

Level

Senior

Education

Bachelor Of Science

Description :

1. 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.
2. Reviewed and ensured that quality system processes and procedures were in compliance with all required standards and corporate policies.
3. Provided leadership and training on the quality management system to direct managers and staff.
4. Responsible for presenting and elaborating of all departmental procedures and associated documentation during FDA, MHRA, Anvisa, Canada, China, Japan regulatory audits.
5. Led regulatory inspections, including tour of the facility, when senior management was not available.
6. Transferred and implemented new material, chemical, and API incoming specifications.
7. Presented metrics to senior management and colleagues on a quarterly basis.
8. 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.
9. Management of retain and reserve sample program including annual visual inspection for all drug product.

Experience

5-7 Years

Level

Executive

Education

Master Of Arts

Description :

1. Performing regular internal facility audits utilizing state and company required audit tools with immediate notifications of results.
2. 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.
3. 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.
4. Ensuring the facility continues to run consistent with policy and procedure and contract requirements.
5. Monitoring, tracking and making recommendations for all TDOC and CCA policy reviews.
6. 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.
7. Making recommendations to department heads for policy and procedure changes that will increase the effectiveness and efficiency of the facility.
8. 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.
9. Entering the required reports (audits, monthly security inspections, ACI health care outcome measures) into the Steton software program.

Experience

10+ Years

Level

Consultant

Education

BS in Business

Description :

1. 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.
2. Assured compliance to all regulatory requirements, including local health dept., FDA, USDA, Silliker, and customer food safety audits.
3. Conducted in-house plant inspections to assure compliance to all quality programs and processes.
4. Maintained compliance with SSOPs including daily sanitation of processing rooms and equipment, pre-operational sanitation check, and operational sanitation programs.
5. 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.
6. Participated in the development, evaluation, and revision of the plant's emergency response plan.
7. Managed training, disciplinary actions, and annual reviews with a focus on talent development and performance management.
8. Provided training to plant quality and operations teams on relevant topics: GMPs, SOPs, SSOPs, HACCP.

Experience

7-10 Years

Level

Senior

Education

Ph.D. in Food Science

Description :

1. Overseeing a team of 8 engineers working in an agile environment.
2. Enabling team success through advocacy, facilitation, and removing roadblocks.
3. Monitoring the defect tracking system, assigning, and escalating defects as necessary.
4. Communicating QA metrics, test results, concerns, and project status to the engineering management team and other stakeholders in a timely manner.
5. Working closely with development, product management, and technical support to ensure that the quality objectives of all projects are met within schedule constraints.
6. Creating each team members short and long term goals to allow them to succeed and progress.
7. Recruiting, interviewing, hiring, and mentoring/coaching the quality assurance team members to meet business objectives.
8. Exercising good planning and problem-solving skills while working in a fast-paced environment.
9. Leading QA engineer group lead within the team, providing mentoring and acting as an escalation point.
10. 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.

Experience

10+ Years

Level

Management

Education

Diploma

Description :

1. 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.
2. Oversaw quality control and inspection procedures regarding the inspection, control, identification, and handling of parts from receipt to shipment.
3. Responsible for ensuring a robust quality system and adequate resources for an efficient and effective program.
4. Responsible for training employees in accordance with AS9100, customer and regulatory requirements.
5. Assisted in the development of quality requirements in support of new product development including quality planning, test requirements, inspection methods, NDT methods, etc.
6. 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.
7. Reviewed customer contractual requirements to ensure company compliance and correct and accurate implementation.
8. Managed all aspects of quality issues that require customer interface, root cause analysis, corrective action and any coordination with regulatory entities.

Experience

2-5 Years

Level

Junior

Education

High School

Description :

1. Managed overall quality systems including quality engineering, quality inspection, NDI, calibration, DSQR, audits, and corrective action system and served as chief quality customer liaison.
2. 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.
3. Directed ISO, AS9100, NADCAP, and other quality compliance certifications required by customers and/or government agencies, and leads and participates in compliance audits.
4. Communicated and corresponded with customers, suppliers, employees, and management within the company regarding quality issues, problems, and complaints.
5. Managed quality audit program including external and internal audits, corrective actions and follow up.
6. Ensured suppliers are adhering to purchase order and quality provision requirements.
7. Organized meetings with suppliers to obtain cause and corrective actions reports as applicable.
8. 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.

Experience

2-5 Years

Level

Junior

Education

Associates

Description :

1. 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.
2. Providing QA training and coaching to the organization to support compliance with FDA regulations and SQF requirements.
3. Leading cross-functional teams to resolve customer complaint issues by ensuring CAPAs are systemic in nature and eliminating the root cause.
4. Leading internal auditing program and associated training to drive compliance with SOPs.
5. Providing coaching to personnel for understanding and resolution of observations.
6. Reviewing and approving proposed CAPAs to ensure delivery of robust systemic corrections.
7. Implementing an electronic complaint portal and established system reporting metrics.
8. Providing coaching to cross-functional teams on the complaints system, investigation techniques, root cause analysis and development of corrective and preventive action plans.

Experience

5-7 Years

Level

Executive

Education

Bachelor Of Arts

Description :

1. Responsible for the quality management systems and QA personnel at eight Wabtec global services field locations in the U.S.
2. Collected and reported the cost of poor quality metrics for analysis of scrap costs, rework costs, supplier reject costs and process improvement.
3. Provided guidance and mentoring for nonconforming material and process corrective actions for root cause and preventative action planning and implementation.
4. Addressed customer issued concerns for corrective and preventative actions.
5. Developed and implemented a formal quality system manual that aligned and supported requirements defined by Wabtec global services corporate and by AAR M-1003.
6. Implemented project management tools to assist in establishing effective communication of customer requirements to Wabtec global services personnel.
7. Skills used project management skills for improving the internal communication of customer requirements.
8. Developed and initiated programs and procedures to ensure product quality.

Experience

5-7 Years

Level

Executive

Education

MS in Management

Description :

1. Discarded and rejected products, materials and equipment that did not meet specifications.
2. 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.
3. Monitored production operations for compliance with specifications and promptly reported defects.
4. Collected samples during production and tested randomly to determine in-process product quality.
5. Presented clear, organized data in graphs, charts, tables, and written reports.
6. Recorded defects and coordinated issue resolution with the development team and functional leads.
7. Inspected and packaged products meticulously according to manufacturing specifications.
8. Inspected outbound shipments and conducted random sampling to ensure product quality.
9. Performed preliminary, in progress, hidden damage and final product inspections.

Experience

5-7 Years

Level

Executive

Education

GED