Quality Systems Manager Resume Samples

Description :

1. Ensures compliance with all Quality Control regulations to assure the product meets or exceeds all quality standards.
2. Manages equipment quality control - ensures equipment follows standardized evaluation and implementation procedures.
3. Performs quarterly internal audits of the Quality system and laboratory; recommends and follows up on corrective and preventive actions.
4. Oversees the complaints management system and interfaces with the medical staff to immediately review any adverse events that may impact patient safety.
5. Reviews deviation reports and follows up on all proposed corrective actions to ensure effectiveness.
6. Implemented and maintained a document control system, including ensuring change control of documentation.
7. Responsible for internal and external proficiency testing programs, enhancing overall quality assurance efforts.

Experience

2-5 Years

Level

Junior

Education

B.S. QA

Description :

1. Oversaw a team of 60 staff, collaborating with clients to develop and implement customized finishing processes.
2. Maintained up-to-date knowledge of industry standards and best practices.
3. Designed and executed an ISO-compliant quality management system, enhancing operational efficiency.
4. Secured and upheld quality system approvals from international agencies like Nadcap.
5. Ensured adherence to quality specifications through meticulous process monitoring.
6. Delivered training sessions for small and large groups, enhancing team knowledge and compliance.
7. Effectively communicated technical details to customers, improving service delivery.

Experience

10+ Years

Level

Senior

Education

B.S. Quality Mgmt.

Description :

1. Maintained and enhanced quality systems for ISO 9001-2008 certified organization.
2. Conducted comprehensive quality audits on production and engineering processes.
3. Performed supplier quality audits at multiple subcontractor facilities.
4. Initiated corrective actions for deviations, effectively resolving customer complaints.
5. Analyzed production trends and communicated quality issues to management.
6. Executed budgetary and strategic analysis to optimize productivity and quality department efficiency.
7. Streamlined quality control processes, resulting in a 25% reduction in inspection time and increased efficiency.

Experience

2-5 Years

Level

Junior

Education

B.S. QM

Description :

1. Facilitated the implementation of a comprehensive Quality Management System, achieving ISO certification across multiple departments.
2. Consistently recognized for leadership and promoted within two years in previous roles.
3. Led ISO 9001 certification efforts for production centers, resulting in enhanced operational standards.
4. Transitioned over 1000 documents from a manual to an automated system, improving efficiency and accuracy.
5. Developed and refined policies and procedures, significantly enhancing the effectiveness of quality systems.
6. Oversaw Federal and State audits, managing compliance and systematic changes effectively.
7. Conducted training on Excellence through Quality (ETQ), streamlining audits and document control management.

Experience

10+ Years

Level

Senior

Education

B.S. QA

Description :

1. Acted as the management representative to ensure compliance with the organization's registered quality system.
2. Resolved critical quality system nonconformance issues upon hire, enhancing overall compliance.
3. Expanded registration accreditations to the Far East market, increasing market reach.
4. Recruited key personnel for Document Control, Procurement, and HR roles to strengthen the quality team.
5. Hired a Quality Assurance Technician, securing funding through the Oneida County Displaced Workers Program.
6. Created and maintained quality management system documentation, including Instructions for Use.
7. Participated in internal and external audits, contributing to continuous improvement initiatives.

Experience

7-10 Years

Level

Management

Education

B.S. QA

Description :

1. Responsible for in-plant process controls to ensure compliance with company quality and regulatory standards.
2. Managed quality operations to meet company specifications and USDA regulations.
3. Administered HACCP and GMP programs to ensure the highest hygiene and best manufacturing practices.
4. Supervised USDA label submissions and ensured regulatory compliance.
5. Developed customer and factory specifications to enhance product quality.
6. Created systems for incoming products to ensure quality standards.
7. Ensured raw materials, packaging, labels, and final products met acceptance criteria.

Experience

2-5 Years

Level

Junior

Education

B.S. in Q.M.

Description :

1. Improved CAR on-time performance from 54% to 100%, and CAR turnaround from 2 months to 2 weeks.
2. Developed a SharePoint CAR System with automated workflows and conducted capability studies for a multi-million dollar product launch.
3. Utilized advanced statistical tools, including contour plots and Pareto charts, for data analysis.
4. Conducted Design of Experiments (DOE) to optimize welding processes using statistical analysis techniques.
5. Achieved a significant reduction in PPM from 40,000 to 3,000 post-implementation through targeted process improvements.
6. Trained employees on AIAG Core Tools, enhancing team competency in quality management.
7. Improved PPM for key customer Polaris through Six Sigma methodologies, resulting in increased customer satisfaction.

Experience

7-10 Years

Level

Management

Education

BSc Quality Mgmt

Description :

1. Developed and implemented comprehensive quality policies and procedures, enhancing operational standards.
2. Oversaw quality control laboratories and distribution processes to ensure adherence to quality benchmarks.
3. Instrumental in establishing the organization as a leading specialty gas provider, driving substantial revenue growth.
4. Designed analytical labs that expanded product offerings and improved ROI through cost reductions.
5. Enhanced quality analysis methods for specialty gases, leading to improved product integrity.
6. Created and executed an ISO-9000 quality system, resulting in certification and improved business practices.
7. Implemented a business software system that optimized administrative efficiency and record-keeping.

Experience

10+ Years

Level

Senior

Education

BSc QM

Description :

1. Developed a statistically based method for identifying emerging warranty issues.
2. Created an automated algorithm for flagging warranty claims, improving response times by 25%.
3. Established standardized quality metrics and a scorecard for global operations, enhancing visibility and accountability.
4. Architected an automated monthly warranty reporting system, driving global productivity savings.
5. Oversaw ISO 9001:2000 certification for operations, ensuring compliance with international quality standards.
6. Acted as QMS Representative, coordinating all aspects of assessment audits with external registrars.
7. Provided leadership and guidance to ensure all locations adhered to quality standards and best practices.

Experience

10+ Years

Level

Senior

Education

M.S. QA

Description :

1. Provide quality assurance expertise and leadership to ensure compliance with cGMP and customer requirements.
2. Approve or reject components, packaging materials, and finished products based on quality standards.
3. Manage a team focused on quality improvement and employee development.
4. Oversee budget management to enhance departmental efficiency.
5. Conduct internal audits to ensure compliance and drive continuous quality improvements.
6. Support external quality audits from regulatory agencies and customers.
7. Assist in resolving product issues and customer complaints through comprehensive investigations.

Experience

2-5 Years

Level

Junior

Education

B.S. QA