Monthly Archives: September 2016

October Meeting – Plant Tour- GPI Prototype & Manufacturing Services 🗓 🗺

Please Note: Due to ITAR requirements, all attendees must be US Citizens.

Date:

October 12, 2016

Venue:

GPI Prototype & Manufacturing Services
940 North Shore Dr., Lake Bluff, IL US 60044

Agenda:

  • Doors Open: 5.30pm
  • 6.00PM a company history / background
  • Tour of manufacturing facility.
  • Questions
  • Sandwich/pizza & beverage
  • Departure

Dinner Menu:

Sandwich/pizza & beverage

Cost:

  • ASQ Members:                $15US citizens only – Facilities orders
  • Non-Members:                $15US citizens only – Facilities orders

Pre-Dinner Synopsis:

GPI Prototype & Manufactuing Services
Direct Metal Laser Melting

gpi-prototype-buildingGPI Prototype is a service provider of Direct Metal Laser Melting (DMLM), the latest technology for prototyping and additive manufacturing of metal parts. As one of the first DMLM service providers in the country, GPI produces metal parts for applications  ranging from prototypes to production. DMLM is also known by the acronym DMLS, although the process results in full melting of the metal powder, so we have begun to use the more appropriate DMLM acronym.

Utilizing the DMLM process, metal parts of the most complex geometries are built layer-by-layer (down to 20 microns) directly from 3D CAD data. Parts built using DMLM have excellent mechanical properties equivalent to wrought materials, high detail resolution, and exceptional surface quality. The metal powder is melted entirely to create a fully dense, fine, homogenous structure. Unique geometric freedom of design enables DMLM to form cavities and undercuts, which with conventional machining methods, can only be produced with great difficulty, if at all.

Additionally, when a part needs to be tested and re-designed over and over, the lead time for receiving a traditionally tooled part can create a large bottleneck in the final production process.

DMLM produces parts that are extremely high quality and can be built in a matter of hours or days rather than weeks or months. The ability to generate functional metal prototypes in short order radically impacts design processes, accelerating design cycles and time to market.

Furthermore, these parts can undergo functional testing in the environment for which they were designed. This  technology delivers unlimited potential for engineers to create previously impossible solutions, embracing a new era of design-driven manufacturing.

Please Note: Due to ITAR requirements, all attendees must be US Citizens.

Registration is Closed

Senior Manager of Quality Assurance, Nanosphere Inc., Northbrook, IL

Senior Manager of Quality Assurance
POSITION OVERVIEW
The Senior Manager of Quality Assurance will lead, establish, implement and maintain quality assurance systems and activities ensuring compliance with domestic and international quality system standards and regulations for commercial medical devices designed, produced and marketed by Nanosphere. The individual will also provide technical and organizational leadership to Quality / Quality Assurance activities and expand the Quality Assurance function by providing value-added services to the company.  Partners with Manufacturing, Design/Development, Systems Engineering, Quality Control and others cross functionally to deliver the highest quality products.  The individual must be a strategic thinker, good communicator and possess the ability to inspire and lead others.LOCATION
Northbrook, IL
• Responsible for the strategy, administration, and direction of the Quality Assurance organization.  Directs all aspects of Quality Assurance, using a well-grounded understanding of technical, scientific and regulatory issues.
• Monitors the Quality Management System (QMS)
• Directly supervises employees in the Quality Assurance organization.
• Develops, administers, and maintains quality systems required to ensure the company’s products are in compliance with quality standards and regulations.
• Member of the QMT, with responsibility for assigning and monitoring all CAPA activities.
• Functions as an integral member of new product development teams.  Responsible for ensuring compliance during the design control and design transfer processes.
• Participates in new product development team meetings, technical design reviews, and phase gate design review meetings to contribute quality assurance requirements and considerations.
• Leads risk management activities throughout the product lifecycle, including new product development and post production risk management.
• Regularly reviews quality system standard operating procedures and work instructions, making changes as necessary to ensure compliance and efficiency Quality Assurance processes.
• Provides input to the Management Review and Quality Review Board processes.
• Responds to nonconformities identified in internal audits, and to corrective / preventive actions assigned to Quality Assurance.
• Responsible for all aspects of regulatory compliance including FDA regulations.
• Participates in FDA inspections.
• Other duties as assigned

Core Competencies:

• Responsible for responses to inspections, audit and regulatory responses.
• Maintenance of support of the QMS through internal audits, development of procedures, maintenance of quality records and training of office and manufacturing personnel.
• Strong planning, organizing, and communications skills.
• Ability to manage a large volume of information at once, keeping focused on priorities.
• Conscientious, detail orientated character
• Analytical mind set and enjoy working with data and statistical information
• Strong attention to detail with excellent follow-up

Job Specifications:

• Bachelors Degree in engineering or technical field required.  Advanced degree preferred.
• Minimum of 10 years experience in a cGMP environment (ideally in the medical device industry)
• Strong experience and familiarity with product development and manufacturing of products that are highly regulated by the government.
• Management experience in a complex quality assurance / quality systems field.
• Demonstrated knowledge and understanding of the 21CFR Part 820 and ISO 14971:2012 requirements.
• Implement and maintain a quality management system in accordance with ISO 13485
• Ability to provide leadership to others in the organization through influence, innovative practices and coaching skills to foster a corporate culture that of responsiveness, compliance awareness, self-regulation, quality system ownership, challenge of status quo, and continuous improvement in order to achieve the highest level of compliance.
• Excellent problem solving methodology, using industry accepted concepts and tools to solve complex problems in creative and effective ways as they apply to compliance issues.
• Possesses a strong scientific and technical background, sufficient to establish credibility with senior management as well as the manufacturing and product development teams.
• Hands-on ability to sort through technical complexities and work in a flexible changing environment
• Ability to work varied and extended hours/days, as business dictates.

It is impossible to list every requirement for, or responsibility of, any position.  Similarly we cannot identify all the skills a position may require since job responsibilities and the Company’s needs may change over time.  Therefore, the above job description is not comprehensive or exhaustive.   The Company reserves the right to adjust, add to or eliminate any aspect of the above description.  The Company also retains the right to require all employees to undertake additional or different job responsibilities when necessary to meet business needs.

Nanosphere is an Equal Opportunity Employer. It is the policy of Nanosphere, Inc. and its subsidiaries to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, gender, religion, national origin, disability, veteran status, age, marital status, sexual orientation, genetic information or any other protected group status and further, to take affirmative action to employ and advance in employment minorities, women, disabled persons, disabled veterans, recently separated veterans, Armed Forces service medal veterans or other protected veterans.

To apply: http://www.nanosphere.us/company/careers

PMI Chicago Chapter – Annual Symposium 🗓 🗺

Invitation from the Project Management Institute (PMI) Chicago Chapter

pmi_logo

PM Symposium 2016 – This year’s focus is on NextGen Project Management
October 21, 2016 7:00 AM CDT to 5:00 PM CDT at the Donald E Stephens Convention Center 5555 N River Rd., Rosemont, IL 60018

The event will host 15+ speakers with multiple tracks (Strategic & Business Management, Technical, Leadership, and Workshop and Panel Discussion), networking and knowledge sharing opportunities as well as fine food in a professional setting.

Hurry Up. Registration ends Oct 10th 2016.
See more at: http://pmi-chicagoland.org/meetinginfo.php?id=332&ts=1472793248

September General Meeting 🗓 🗺

September, 2016
From your program chair, James Persaud

My fellow members, I take it that you are enjoying the summer season. While you continue to enjoy it, please know that your ASQ Chicago section continues to plan an exciting and interesting program for the rest of the year. So, welcome back to our program.

We have a general meeting on September 14th 2016. Our presenter will expand on Failure Mode and Effects Analysis; FMEA. Our other speaker will enlighten us on implementing the Changes to the ISO 2015 Standard.

Thanks to all of you what attended our August meeting. We were at capacity. It is really encouraging to our ASQ members who put so much effort in arranging the meeting, topics, venue, registration, badges etc. when you do show up at the meetings. Our attendance continues to grow. Let’s continue this trend. Please bring along your boss – a coworker, a friend, a family member a neighbor. We all benefit from this.

Your Chicago section Leader members appreciate meeting you and hearing from you.
Looking forward to meeting you and your companion at the meeting.

Date:

Wednesday 14th September 2016

Time:

Registration starts at 5.30pm

Venue:

DoubleTree by Hilton Chicago – Oak Brook
1909 Spring Road Oak Brook, IL 60523

Menu:

  • Citrus Chicken
    • Grilled Chicken Breast w/ Citrus Butter Sauce
  • Assorted Rolls with whipped butter
  • Market Greens salad
  • Mixed Greens, Shredded Carrots, Sliced Cucumber, Cherry Tomatoes, Red Onions, and choice of Dressing
  • Steamed Broccoli
  • Blended Wild Rice
  • Chef’s Choice of Dessert
  • Freshly Brewed Coffee, Decaffeinated Coffee, Specialty Teas, Lemonade or Iced tea

There will be giveaways and prizes. You will get an opportunity to give your feedback.
Your Chicago section board members are anxious to meet you, answer any questions and may even help you to become a volunteer. See you at the meeting.
Remember, anyone can attend the meeting at no charge. There is a charge to have dinner. Come on out, bring someone along.

James Persaud
Vice Chair Program


Laura Clymore Ellman
www.linkedin.com/in/lauraellman1

lauraLaura has worked in quality in manufacturing, product design, process scale-up and compliance for nearly twenty years. She has had the pleasure of working in a wide variety of technologies such as high speed coating, paper conversion, injection molding, high speed stamping, plating, printed circuits, 3D printing, measurement technologies, and assembly. With a masters in statistics and just enough curiosity, Laura has learned just enough to be … ?

Title of Talk:

For Me, Effective Application of FMEAs

Laura has done FMEAs for quite a few years and would like to share some insights into making them more useful and less painful.

Outline:

  1. Quick overview of FMEAs
  2. Usage Flowchart
  3. Risk in Compliance Areas
  4. Tips from around the www world
  5. Recap

Dan Brown
https://www.linkedin.com/in/dbperformancesolutions

Dan is President of DB Performance Solutions, LLC and a Lead Auditor for EagleDan_Brown Certification Group. Dan has been a quality professional for over thirty (30) years in a variety of industries, including chemicals, pharmaceuticals, medical device, nuclear, sales incentives and machinery rebuilding and repair industries. He has held a variety of positions, from Laboratory Technician to Operations Manager. Dan holds a Bachelor of Science in biology from Aurora University and a certificate in Quality Management in Manufacturing from DePaul University. Dan has been a member of the American Society for Quality since 1987 and has been an ASQ Certified Quality Auditor since 1989. He has worked with ISO 9001 since 1989.

ISO 9001:2015 – Strategies for Effective Implementation

Abstract

The ISO series of standards are built on a continuous improvement model, therefore they must be reviewed periodically for suitability and effectiveness. The latest revision to ISO 9001 has been released. This presentation explores these changes and their impacts on your organization with a focus on implementation strategies. Strategies to be discussed include companies with multiple certifications where the requirements are no longer harmonized.

Because this workshop will focus only on the changes to the standard, it is advised that attendees have a basic understanding of the ISO 9001:2008 standard prior to attending.


Registration is Closed