WEDNESDAY  May 22, 2013   

6 – 9 pm

ASQ 702 San Gabriel Valley

Presents  

Quality Cross Roads

Presented by Mike Hoss

 For many years quality professionals across all line of businesses have struggled with cross roads. Value adds vs. compliance, prevention vs. detection, operation’s role vs. quality professional’s role, Cost of Quality vs. ROI…

Let’s explore innovative approaches navigating through cross roads, building alliances and recognizing true value of quality and its natural ties to productivity, safety, schedule, customer satisfaction and ultimately bottom line.

* “The balanced scorecard retains traditional financial measures. But financial measures tell the story of past events, an adequate story for industrial age companies for which investments in long-term capabilities and customer relationships were not critical for success. These financial measures are inadequate, however, for guiding and evaluating the journey that information age companies must make to create future value through investment in customers, suppliers, employees, processes, technology, and innovation.”

The balanced scorecard views the organization from four perspectives, and suggests processes to collect data and develop metrics for each perspective:

1.  Learning and Growth

2.  Business Process(es)

3.  Customer

4.  Financial

*Adapted from Robert S. Kaplan and David P. Norton, “Using the Balanced Scorecard as a Strategic Management System,” Harvard Business Review (January-February 1996):

Speaker Chet Franklin:
In the 1960’s, Phil Crosby, started his ITT corporate training in Zero Defects policy. Chet worked at ITT as a Project Engineer and was one of Phil’s trainees. That was when he first joined ASQC. In the 1980’s there was training in TQM. As an engineering manager at Hughes Aircraft he lent two of his engineers to GM to be on a Six Sigma team with Motorola. They brought back Six Sigma principles and Chet included those in his staff training.  His other training has included ISO 9000 Lead Auditor, Lean Six Sigma and Six Sigma Green belt. He has conducted supplier audits and audits for ISO 9000 and ISO 17025.

He has developed and conducted training on TQM, Teaming, SPC, Laboratory Accreditation, Measurement Uncertainty, Earned Value Management, FMEA and other topics.  He is also chair and Programs Chair of ASQ Section 711, and principal in the Franklin Training Group.

Please join us!  We are meeting at the:

HomeTown Buffet!

For directions, go to our website at  www.asq711.org

John Schulz, Secretary

Job Description
• Manage Regulatory Affairs activities to include, but not limited to:
o Canadian Regulatory Submissions
o International Regulatory Submissions Teams
o Emerging Market Regulatory Strategy
o Global Product Assessments and Approvals
o Product Development Teams
o Regulatory Guidance for
 Change Control
 Product Review Boards

Requirements
• BS degree minimum in life sciences, advanced degree preferred
• 8+ years of experience in medical device industry
• FDA and Global Regulation requirements for Medical Device product lifecycle
Please contact:
Lewie Casey
Talent Manager
Phone: 818-552-4173
Email: lcasey@medexecintl.com

Job Description
• Direct Regulatory Affairs activities to include, but not limited to:
o Domestic and Global Regulatory Intelligence
o Regulatory Strategy
o Regulatory Communication
o Global Regulatory Policy
o Global Regulatory Compliance
Requirements
• BS degree minimum in life sciences, advanced degree preferred
• 10+ years of experience in medical device industry
• Leadership experience and expertise in the medical device industry
• Global and Domestic Travel
Please contact:
Lewie Casey
Talent Manager
Phone: 818-552-4173
Email: lcasey@medexecintl.com

Contact:
Jan Clements
Talent Manager
MEIRxRS
jclements@meirxrs.com
818.552.2105

Contact:

Jan Clements
Talent Manager
MEIRxRS
jclements@meirxrs.com
818.552.2105

• Plan, manage and execute company’s New Customer Training and certification program worldwide, implement Staff and Surgeon training modules, develop strategies for training global field team.
• Associated to training and monitoring activities, the candidate will support implementation and execution of company’s podium and evidence plan, including:
o Planning, design, and execution of single or multi-center clinical studies prior and/or subsequent to commercialization, and secures the quality of the data documentation.
This position reports directly to the VP of Medical Affairs.

Essential Duties and Responsibilities (fundamental job duties):

• Professional education
o Development and implementation of training programs, tools, and certification processes
o Responsible for tracking outcomes globally
o Trains and updates study and commercial sites in the appropriate patient selection, surgical application and technique and provide support during surgery. Secures the appropriate follow up (medical regimen, post-op visits, tracking outcomes) are routinely completed by the users

• Publication strategy
o Implement and execute evidence plan
o Ongoing management of peer to peer, podium, and trade publication development and submissions
o Review and interpret study results as well as generates and/or reviews publications, posters and scientific presentations

• Field clinical support
o Post market clinical study support, as well as field clinical support and training
o Interaction with users of product in the field (study sites, commercial users, KOLs).
o Available for training new accounts
o Expert resource to commercial team

• Professional relations
o Supporting KOL program and advisory board strategy

Qualifications/Requirements:

Required experience:
• Experience building and implementing a complex clinical education process
• Experience working closely with physicians globally
• Experience serving as expert resource to sales and marketing teams
• Ability to clearly communicate complex messages to commercial accounts (surgeons, staff, etc) and to internal field personnel
• Approximately 25% globally. Travel includes attendance to selected scientific congresses.

Preferred experience:
• Professional degree (MD, OD, PhD, PharmD) with appropriate clinical and medical affairs experience
• Experience in Ophthalmology (ideally cataract and refractive surgery)
• Experience developing and executing a medical publications strategy
• General knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in developing and implementing clinical trials
• English is required. A second language is a plus.

Skills required:
• Demonstrated strategic skills and previous management experience
• Understands statistics to evaluate if reported data is scientifically sound
• Ability to establish and maintain long-term relationships with field team, external customers and thought leaders
• Ability to interact externally and internally to support global business strategy
• Execution and Project Management
• Long term planner, strategic thinker
• Team-building and Leadership skills
• Ability to make clinical decisions on patient safety
• Be known as a person who has high integrity, sound character and a tremendous work ethic.

Management of subordinates:
At present, the position is “stand alone”. When opportunity presents, the position responsibility will extend to managing subordinates field clinical application specialist(s).

Contact:
Jan Clements
Talent Manager
MEIRxRS
jclements@meirxrs.com

by Rosemarie Christopher

In an era when many workplaces are in flux, it may seem like there is little opportunity to build your personal brand and influence organizational culture. I would argue there’s no better time to do so than when there is momentum for change already building around you.

Your personal brand is your style. It is composed of your values, abilities, strengths and limitations. These denominators influence how you put your skills and experience to work. The most successful employees, knowingly or not, align their personal brands with their organizations’ cultures.

Change causes a degree of disruption and chaos in the workplace. When an organization is in flux, a specific brand is sought after. Employees that brand themselves as change agents, strategists or influencers are highly valued. In addition to being capable of adjusting to change, the most successful workers also will demonstrate a willingness to help manage or carry out change.

In my experience, many workers give the impression that they do not like change. An unfortunate truth is that those who get stuck in ruts will lose out. Organizations don’t want to push boulders. Some personalities and generations are better at going with the flow than others. If you’re not wired to embrace change, there are measures you can take to help you adapt.

Soften up

Professionals often enhance their brand by sharpening their hard skills first. One way to update hard skills—technical and scientific mastery—is to earn new certifications (ASQ alone offers 17) and complete continuing education coursework. You can prepare for certifications and take coursework virtually or through instructor-led courses.

While hard skills are certainly important, professionals often overlook the development of soft skills as a continuing education opportunity. Soft skills are increasingly important as roles become more multidisciplinary and job descriptions blur. Employers seek a greater amount of direct collaboration as they struggle to do more with less of everything, including human resources. In taking on extra projects or responsibilities, you may find yourself needing soft skills that have been dormant for years or were never fully developed.

Opportunities are everywhere

Soft skills, developed in good measure, complement technical mastery. Just as there are ways to develop hard skills, there are also ways to strengthen soft skills. The best approach to develop soft skills depends on individual career goals.

Verbal communication skills can be strengthened by joining a public speaking and leadership skills-building club, such as Toastmasters. Another way would be to step up as a leader of an interest group relevant to your organization or industry. When I decided I wanted to improve my public speaking ability, I became visible in organizations that support my industries: ASQ, the Regulatory Affairs Professional Society based in Rockville, MD, and the Board of Councilors of the University of Southern California School of Pharmacy in Los Angeles.

Participating in an industry-focused group or association is also a way to gain management skills. By leading groups of volunteers, you exercise skills such as conflict resolution, teamwork, collaboration and negotiation. Furthermore, this experience offers you a non-threatening learning environment (no one can fire you; you’re a volunteer).

You don’t have to go far to find development opportunities. Even mentoring others or helping an overloaded colleague gives you extra experience that may prepare you for your next career move—whether it’s at your organization or elsewhere.

As both ourselves and the world change, it’s important to periodically evaluate our work preferences and goals, assess how we like to interact with others and determine where we are on our personal continuous improvement journeys. Periodically evaluating soft skills using online assessments is branding at its best. Formally assessing the power of your brand confirms to bosses, department heads and colleagues that among the ranks of keepers is a proactive and collaborative strategist.

Employers can only work with what employees give them. Organizations realize that there is a huge talent shortage that is not going away overnight. They are working diligently and strategically to retain top employees and recruit the best. Now is the time to take control of your brand and your career.

Published in Quality Progress

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