Quality Manager
Resume:
AnnMarie Powers
Cell 440-***-****
abknqt@r.postjobfree.com
abknqt@r.postjobfree.com
Objective:
My objective is to secure a position in Quality Assurance. With the responsibility of maintaining quality
objectives and goals.
Qualifications:
I have extensive knowledge of the ISO 9001, ISO 13485, AS9100 standards along with several years of
auditing to these standards. I have knowledge of FDA regulations (CFR 820) and been audited from the
FDA with zero findings. I have been a member of the review process for CNC Machine validations,
software validations, and process and product validations. I have knowledge of geometric tolerance and
inspection measurement devices. I have extensive knowledge of process requirements within a Quality
Management System as a:
Manager Trainer Facilitator Lead auditor Inspector System Quality Engineer
Employment History:
Nook Industry’s 216 271 7900ext 320
August 4th 2010 –Jan 16th 2015
RMA Coordinator
• Managed the RMA process
• Quoted repairs and replacement
• Review and evaluated warranty products
• Structured jobs within the ERP system for the products needed for the returns
• Reviewed issues with the customers on warranty and non warranty products
• Worked with in all areas of the processes to ensure products were reviewed for customer issues on
returns.
• Lead a team in the process to improve through put and quality issues.
• Worked with customers internal and external to resolve application issues.
Quality Engineer
• Played a lead role in achieving the AS9100 certification in January 2014.
• Responsible for the Document control system including review of all Quality documents.
• Created new procedures and work instructions.
• Lead the internal ISO/AS 9100 system, scheduled internal audits, compile audit questions,
introduced process audits to the auditing system and ensured a smooth transformation from
procedural audits.
• Lead and completed supplier audits.
• Managed CAPA system Implementing Corrective actions Review CA’s for effectiveness. Worked
directly with management to ensure that a firm corrective action plan was in place to prevent re
occurrences of non conformances. Ensured that actions that were completed were effective.
• Prepared AS9102’s FAI reports and ensured executed correctly from inspection.
• Defined inspections methods
• Trained and guided in root cause methodology such as fish bone and 5 why’s.
• Worked with suppliers on quality issues and quality requirements. (Supplier Quality Engineer)
Audited the suppliers on their Quality systems.
• Work with Corporate Customers on quality issues to correct within the company.
Mike’s Cleaning Service 440-***-****
965 Becker Court .
Eastlake Oh
December 9th 2008 September 2011
Operations Manager
• Manager of the Quality and training of the cleaning technicians.
• Work directly with the customers on concerns with the quality of service.
• Training with employees in all aspects of the business needs
• Work directly with the owner of the company for scheduling and prioritizing needs of the
customers.
Norman Noble 1-216-***-****
November 4th 1997 to May 30th 2008
Lead Auditor/ Quality Engineer
• Managed the Quality management system for ISO 13485 2003
• Wrote, reviewed, and implemented procedures and work instructions.
• Certified Lead Auditor of ISO Quality system 9001 2000/13485 2003
Scheduled and performed internal audits and supplier audits
• Reviewed FEMA’s, validations, and amendments for accuracy and completion
• Managed CAPA system
• Implementing Corrective actions and reviewed CA’s for effectiveness
• Work directly with the customers to implement process changes. Communicated the changes to the
work force.
• Training with employees in all aspects of quality and the quality management system. Trained
employees on requirements for the GMP’s. Training on customer requirements and specifications.
Superior Products 216-***-****
August 12th 2008 to December 9th 2008
Quality Assurance Manager
• Manager of the Quality department and the Quality management system. Maintained the ISO
9001 2000 certification. Presented quality issues at management review, this ensured that senior
management reviewed all required areas per the ISO standards and FDA regulations.
• Certified Lead Auditor of ISO Quality system 9001 2000/13485 2003
Scheduled and performed internal audits and supplier audits
• Managed CAPA system Implementing Corrective actions Review CA’s for effectiveness, Reviewed
effectiveness on any 483’s and ensure the CA’s implemented were effective.
• Work directly with the customers to implement process changes to reduce scrap rates, reduce
customer returns, reduce reworks, and increase production throughout the processes.
• Training with employees in all aspects of quality and the quality management system. Trained
employees on requirements for the GMP’s
AnnMarie Powers
Cell 440-***-****
abknqt@r.postjobfree.com
abknqt@r.postjobfree.com
Norman Noble 1-216-***-****
November 4th 1997 to May 30th 2008
Lead Auditor/ Quality Engineer
• Managed the Quality management system for ISO 13485 2003
• Wrote, reviewed, and implemented procedures and work instructions.
• Certified Lead Auditor of ISO Quality system 9001 2000/13485 2003
Scheduled and performed internal audits and supplier audits
• Reviewed FEMA’s, validations, and amendments for accuracy and completion
• Managed CAPA system
• Implementing Corrective actions and reviewed CA’s for effectiveness
• Work directly with the customers to implement process changes. Communicated the changes to the
work force.
• Training with employees in all aspects of quality and the quality management system. Trained
employees on requirements for the GMP’s. Training on customer requirements and specifications.
Education:
6/11 AS9100 Lead Auditor RABQSA Certified (Certified Lead Auditor of ISO Quality system 9001
2008 AS 9100 Rev C auditor)
6/07 Continual training Certified Lead Auditor ASQ, ISO 13485/9001
7/06 Certified Quality Lead Auditor ASQ
9/04 Process Auditing Quality WBT
3/03 OGP (Optical Gage Products) Smart Scope Program training class
References
Bill Getchell Joy Mining
abknqt@r.postjobfree.com
Denise Zak Mold Master 440-***-****
Said Akki
Purchasing Manager
Rick Frank
440 463 abknqt@r.postjobfree.com
Contact this candidate