Job Function Summary:
Responsible for providing leadership, managing, planning, executing and reporting on regulated Quality Assurance activities for internal/external audits. This individual is responsible for performing Internal, domestic and international audits(as appropriate) that ensure compliance with the FDA QSR, ISO, MDD, CMDR requirements, and other worldwide health authority regulations/guidelines, site SOPs, protocols, and industry standards, as applicable. The Auditor acts as a compliance resource and provides recommendations for corrective action and tracks corrective action commitments until closure.
Continue reading Senior Quality Engineer – Healthcare company
The 40th ASQ North Jersey Annual “Spring Quality Training Conference” March 29th, 2018 organized by the ASQ North Jersey Section 304
Proposals will be reviewed by the Committee for relevance, innovation, demonstrated application, and technical content. Priority will be given to new and unique approaches that have resulted in measurable improvements to organizational processes and customer satisfaction. The following is a list of suggested topics; however, you are not limited to the list. Feel free to send proposals in all areas that you feel are relevant.
Continue reading CALL for PAPERS!!!
This month’s ASQ member gift bundle: Auditing
In this month’s gift, ASQ is revisiting a very important topic and expertise critical to any organization—auditing.
- New webcast on advanced quality auditing
- Additional webcasts on auditing basics and process auditing
- Complete e-book, Auditing Beyond Compliance
- Checklists, tools and templates
- And much more!
Continue reading ASQ April Membership Gift: Auditing
39th Annual ASQ North Jersey Section “Spring Quality Training Conference” will be held on April 13th 2017.
Proposals will be reviewed by the Committee for relevance, innovation, demonstrated application, and technical content. Priority will be given to new and unique approaches that have resulted in measurable improvements to organizational processes and customer satisfaction. The following is a list of suggested topics; however, you are not limited to the list. Feel free to send proposals in all areas that you feel are relevant to this year’s theme “Quality Takes More Than Luck.”
Some Proposed Focus Areas:
- Leadership (Innovation, Change, Empowerment, Alignment to Goals)
- Auditing (Internal, External, 3rd Party, ISO, 16949, GMP)
- What’s New (Environmental, Regulatory, lessons learned etc.)
- Electronics (J-Standard, testing, inspecting, CEPM)
- FDA Regulated (Pharma, Medical Devices, Lessons Learned, Risk 14971)
- Lean and Six Sigma
Timeline Submit ASAP. The deadline for proposal submissions is September 30th, 2016.
Continue reading Call for Papers!! North New Jersey Spring 2017 Conference
Happy 70th, ASQ! In honor of their 70th year ASQ has stepped up their Member Gifts to give you even more useful resources as a thank you for being part of the community that promotes the ever-expanding uses and value of quality. For starters we’re focusing on one of the core elements and roles in quality — auditing.
Below you’ll find basic introductions to auditing, video overviews, webcasts mini-courses on auditing basics and process auditing, a complete e-book on e-auditing, and lots of additional articles, tools, and templates. Yes, this gift is one you should save and use time and again, if you have anything to do with auditing, risk management, CAPA, or continuous improvement projects. Enjoy!
Your exclusive member gift will be available through May 31.
The Auditing Bundle includes:
This workshop is designed for auditors-in-training, auditors, audit supervisors and audit managers who have responsibility for auditing processes within management systems (e.g., quality, environmental, health and safety, and security management systems) in accordance with the requirements of ISO 19011, ISO 9001, AS9100, ISO/TS16949 and similar standards.
The workshop covers in detail (a) the considerations for establishing the overall auditing system (b) the differences in the processes for internal audit, supplier audit and third party audit, and (c) the process for performing an individual audit of any management system, in addition to quality, environmental, health and safety management systems – other than a financial management system.
Upon completion of this workshop, one will be able to:
- Use audit terminology;
- Understand the differences among internal, supplier and third party auditing;
- Understand the factors to be considered in establishing an integrated auditing system;
- Design, and, implement an integrated auditing system;
- Plan the auditing activities for a given time period;
- Establish the audit objective – "compliance-based" or "effectiveness-based";
- Establish the audit scope – "risk-based" or "non-risk based";
- Determine data collections techniques – "system-based" / "program-based", "performance-based" and/or "results-based";
- Lead the performance of any individual audit, step-by-step, in detail;
- Manage and assess the effectiveness of the integrated auditing system.
Continue reading Auditing Management Systems Workshop