Respected California firm has a strong foothold in the CA market is looking to add Transportation to their service list.  This candidate will need to be a CA licensed GE with a strong background in the CA transportation market.  This Geotech will need to have a solid business development client list as well - P&L responsibility.  The role will also require the individual to grow the Transportation team.

With this director level role their is a path towards equity for the right indivual.  The base salary will be highly competitive with a 15% bonus componant, 401k, Insurance, Gas Card, etc...

•Reports directly to VP, GM of
Strong dotted line report to HI/PM Sr. Director, Quality and Regulatory
•Key member of business management team
•Functional responsibility for Q&R management at remote locations
•Direct management of local Q&R staff (8 ee’s)

•compliance, sustainability, product quality and proProvide management oversight and strategic direction for quality and regulatory activities within the business including: regulatory approvals, quality and environmental management systemcess improvement.
•Provide leadership, vision, coaching, mentoring for the business’ quality & regulatory organization
•Provide multi-site leadership to ensure the ongoing performance, safety and compliance of products and services
• Drive regulatory strategy within the business to meet product development and release schedules.
• Work closely with the cross-functional management team to develop and improve business results through processes to speed time to market without sacrificing quality or compliance.
•Provide leadership to all business locations to ensure product quality and quality system compliance to ISO 13485 and FDA Quality System Regulation (21 CFR 820), Environmental compliance to ISO 14001, Canadian CMDCAS, Japan PAL regulation and all other worldwide medical device quality and environmental regulations.
•Coordinate quality and regulatory activities between business lines to create a common quality and regulatory direction for the business.
•Identify and implement best practices between all locations to improve efficiency without risking compliance.
•Champion product quality improvement
•Provide regulatory information, opinion and interpretation to entire business.
•Manage FDA product submissions.
•Interface with FDA (or other regulatory agencies).
•Create a quality and regulatory community within the business.
•Participate in Quality Council, which sets quality policy and resolves systemic quality issues for entire business line.
•Conduct quality system management reviews.
•Develop and implement multi-site Q&R processes to improve business results by aligning with business strategic initiatives and priorities, while introducing flexibility and efficiency.
•This position is the authority in the Business regarding the following key issues and decisions:
Whether product can legally ship.

Whether product that has shipped to customers must be recalled for safety reasons or for violation of country law.
Reportability to worldwide regulatory/government agencies, and subsequent public disclosure, of device malfunction or serious injury or death.
Business risk and strategy surrounding acquisition or integrating another company or conducting business with a device OEM business partner
Most effective strategy for process harmonization and improvements to minimize product cost, increase business efficiency, improve financial results, and speed time to market
Criteria for placing device production on hold pending investigation of a potential safety issue or a legal violation (adulterated product)
Exclusion or inclusion of certain device features based on regulatory/legal risk and how device features may be advertised to the public to ensure legal compliance.

Bachelor’s degree in a technical discipline. An advanced degree in law or management is strongly preferred.
•Minimum 5-10 years of progressive management experience in a responsible quality assurance/regulatory affairs role in a software medical device environment.
•Expertise in FDA QSR, ISO13485 and European medical directives.
•Working knowledge of FDA regulations including 510(k) and MDR.
•Demonstrated ability to lead, communicate, interact and influence effectively at technical and management levels across functions, entities and external agencies.
•Proven leadership in formulating and implementing global strategies to ensure product quality, compliance with worldwide regulations, and timely product approvals to maximize business profit.

Proven track record of positive change management skills.

Position Overview

This position is responsible for driving our performance process and best practices across the company.

Responsibilities

. Managing Performance best practices across our products & services
. Capturing industry best practices from eco-system partners, clients and employees
. Create testing templates for the salesforce to leverage in sales campaigns that can (a) outline how to engage in a performance test, (b) how to maximize success by providing clients outlines of how to test, and (c) how to create success criteria to maximize opt to win
. Tracking all performance tests in the company and managing matrix team to optimize each engagements success
. Driving thought leadership in the company around performance methodology, process, and market positioning
. Working cross functionally across org to drive optimization around performance and results. This includes working w/ Ops, Dev, Network, Product Management, Sales and Channels

Requirements

5+ Years Working in a Performance Management Capacity
Data Analytics / Performance Management Experience Required
Ideal Candidate would possess Content Devlivery Network Experience and Understanding

Key to this one:

* Background also from some type of capital equipment which include robots and support systems.

* 3D CAD background and use of SolidWorks.

* Project management background.  Wear a lot of hats in this small engineering dept.

* Background from a machine shop ( and certified Journeyman a plus)

* Experience with fabrication processes such as metal casting and plastic molding.

* FEA, Matlab analysis  background.* Base salary  $85,000 to $105K.* Open because of a retirement.

* LOCAL CANDIDATE----NO RELO available.* Semi conductor equipment background would work well for this job.

Budgeting/P &L. Manage $4-15 million project budgets. Experience in managing domestic and offshore teams with favorable results. Travel is required and should possess a BS/BA degree. Should possess SDLC experience with requirements analysis, development and testing of software with enterprise and e-commerce technologies. Demonstrated ability in developing and building client relationships. Ability to handle tough situations and achieve a favorable outcome.

Ideally currently working for or recent past experience at Client Partner level from one of these types of Top Tier of firms: Accenture, ACS, BearingPoint, Cambridge Associates LLC, Cap Gemini, Cognizant, CSC, Deloitte, EDS, Ernst & Young, First Manhattan Consulting Group, Fujitsu, Genpact, HCL, IBM Global Services, Infosys, Intelligroup, NIIT, Sapient, Satyam, TCS – Tata, Unisys, Wipro Aztec Software, Exigen, i-flex Solutions, iGate Global Solutions, Luxoft, MindTree Consulting, MPhasis, NESS, Patni, Perot, Polar, Steria, Tech Mahindra, Tieto Enator 

Demonstrated ability to perform technical program and project management of geographically disbursed teams using established criteria and professional standards. Work with architecture teams to deliver full life cycle technical solutions.

Must be able to manage teams of 20-30 consultants in addition to international projects.  

Experience with on-site/offshore model is strongly desired.

7+ years experience with 3-5 managing in a development environment. Excellent communicator and be able to communicate effectively along vertical and horizontal planes internally and in client organizations. Able to multitask with rapidly changing priorities and manage multiple tasks in a dynamic environment; detail-oriented and manage and maintain all facets of complex assignments; problem solver and be able to identify strategic solutions to business problems with enterprise-wide implications. Must demonstrate flexibility to work among diverse corporate environments, industries and technical and non-technical audiences.

 

Demonstrated ability in dealing with emergencies. Should be comfortable in groups/teams and be able to both lead and follow. Must bring top-notch consulting/ relationship management skills and a deep appreciation of IT tools, techniques, systems and solutions.  Will be held accountable against Measurable Revenue/Profit Growth within set timelines. Should possess in any of the following: relationship based marketing; M&A desk in investment banking; business development in professional services; management consulting firms; private banks; marketing companies; high end technology companies. Travel is required and must possess a BS/BA degree. 

Past Account management is a must, in an off shore environment. P&L $15m – $25m.

Ideally currently working for or recent past experience at Client Partner level from one of these types of Top Tier of firms:

Accenture, ACS, BearingPoint, Cambridge Associates LLC, Cap Gemini, Cognizant, CSC, Deloitte, EDS, Ernst & Young, First Manhattan Consulting Group, Fujitsu, Genpact, HCL, IBM Global Services, Infosys, Intelligroup, NIIT, Sapient, Satyam, TCS – Tata, Unisys, Wipro Aztec Software, Exigen, i-flex Solutions, iGate Global Solutions, Luxoft, MindTree Consulting, MPhasis, NESS, Patni, Perot, Polar, Steria, Tech Mahindra, Tieto Enator 

Specifically growing a select client cluster with clearly established top line and bottom line targets. Will need to sell new service offerings and solutions to the client cluster in order to achieve this. Will need to understand company methodology, delivery process as well as the details of the company’s service offerings. Will need to work with Solutions Leaders and Subject Matter Experts to achieve goals with efficacy.  Responsible for establishing and managing client relationship with key decision makers. Must be able to establish and build "trust" and leverage client context by understanding client’s overall business goals. Be able to position Client as a Strategic IT partner and identify avenues for Client to implement IT solutions.  Responsible for overall account to include work quality and customer satisfaction. Will manage Account and Project Manager combination to achieve client goals. Contribute to new business development efforts in other verticals and facilitate those offerings.