Job Description :
Hello,
Here is the urgent position for one of our client in MA-Littleton .looking for Principle Quality Engineer. If you are interested please send me your updated resume with best contact number.
Here is the Job Description:
Responsibilities may include the following and other duties may be assigned. Leads design assurance activities in support of development for electromechanical systems that utilize microcontroller technology. Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University DIFFERENTIATING FACTORS Autonomy: Recognized expert, managing large projects or processes . Exercises considerable latitude in determining deliverables of assignments, with limited oversight from manager . Coaches, reviews and delegates work to lower level specialists. Organizational Impact: Contributes to defining the direction for new products, processes, standards, or operational plans based on business strategy with a significant impact on work group results . May manage large projects or processes that span outside of immediate job area. Innovation and Complexity: Problems and issues faced are difficult, moderately complex and undefined, and require detailed information gathering, analysis and investigation . Develops solutions to moderately complex problems, and/or makes moderate to significant improvements of processes, systems or products independently to enhance performance of job area. Implements solutions to problems. Communication and Influence: Represents organization as a primary contact for specific projects and initiatives; communicates with internal and external customers and vendors at various levels . May negotiate with others to reach understanding or agreement, and influence decisionmaking. Leadership and Talent Management: Typically provides guidance, coaching and training to other employees within job area. Typically manages major / moderately complex projects, involving delegation of work and review of work products, at times acting as a team leader.



Primary Skills:

Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience. May have broad knowledge of project management



Secondary Skills:

ASQ Certification in Quality or Reliability.
Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, IEC 62304, IEC 60601-1 and MDD.
Working knowledge of hardware development for medical devices.
Ability to author technical reports, business correspondence and standard operating procedures.
Ability to apply knowledge and work with development and supply vendors to ensure compliance to client requirements.
Strong verbal and written English communication skills with an ability to effectively communicate at multiple hierarchal levels in the organization.
Ability to multi-tasks, prioritize, meets/exceed deadlines and hold themselves, and others accountable.
Self-Starter with a sharp focus on quality and customer experience.



PPAP,PFMEA,Minitab, Control Plans,Process Validation & Verification,Quality,CAPA,design assurance, processing material - microcontroller technology. inspecting, testing and evaluating the precision and accuracy of products and production equipment. incoming material, production control, product evaluation and reliability, inventory control and/or research and development. Project Management



Educational Qualifications

Requires a University Electrical Engineering Degree and minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience