Control in Japan with Align Technology


ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Investigate and propose new ideas to improve the actual process, based on the needs of the company: production, quality, clinical improvements.
  • Research, develop and implement projects from the beginning to completion.
  • Implement and maintain control mechanisms and systems to follow up, measure the impact, and receive feedback of already implemented projects.
  • Provide periodical advances to the supervisor on the development of the projects.
  • Ability to manage a group of projects at the same time.
  • Use statistical tools, problem solving, lean manufacturing, and improvement continue tools as required and his/her regular duties.
  • Risk Assessment on new products and processes.
  • Responsible for defining documentation and processing times of new and existing processes.
  • Lead internal, and/or external cross-functional teams based process development and improvement efforts.
  • Involve the correct people into a project, assign responsibilities and verifies the completion of the tasks of the group
  • Coordinate meetings with other representatives from different departments to seek a better solution to the problems
  • Comply with all safety policies, practices and procedures.Report all unsafe activities to supervisor and/or Human Resources.
  • Comply with an excellent relationship with hisher peers, supervisors, internal customers and other levels of the corporation.
  • Chair meetings and lead projects for corrective action and/or preventative action.
  • Responsible for solving any problem in data transfer-scale if necessary.
  • Responsible for the status report cases and OTD.
  • Responsible to analyze the causes and corrective actions for OTD problems.
  • Responsible for managing the data transfer management
  • Ensure effective compliance with the objectives and deadlines assigned to the group.
  • Other functions may be assigned.

Additional responsibilities:

  • Ensures the effective fulfillment of objectives and deadlines assigned.
  • Participate in proactive team efforts to achieve departmental and company goals.
  • Perform other duties as assigned.

SUPERVISORY RESPONSIBILITIES

N/A

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE

  • BA/BS degree in engineering or the sciences preferred
  • 5 years or more of experience in Process Engineering or related field working on manufacturing improvement projects
  • More than 1 year of experience working with Lean and Six-Sigma projects
  • Experience in Medical Device or Pharmaceuticals manufacturing in a FDA regulated environment helpful but not mandatory

CERTIFICATES, LICENSES AND REGISTRATIONS

Master Black Belt, Black belt or green belt in Six Sigma highly desirable.Demonstrated understanding of Six Sigma methodologies and history of successful application of methodologies is a plus.

SKILLS REQUIRED

  • Must have good interpersonal skills and the ability to work cross-functionally.
  • Must have exceptional problem-solving and decision making skills
  • Must have exceptional level of commitment and a positive can-do attitude.
  • Must be able to make good assessments on what can and cannot be accomplished before making commitments.
  • Must be proficient with Minitab or other Statistical Analysis software
  • Must be proficient with computers and standard software programs (Excel, Word, e-mail, etc.).
  • Must be willing to work overtime, holidays, and weekends as required.
  • Must have leadership skills.

LANGUAGE SKILLS

Strong written and oral communication abilities required. Fluent English required (reading, writing, and conversation).

MATHEMATICAL SKILLS

Practical application of probability and statistics is a plus.

REASONING ABILITY

This position requires the ability to manage multiple projects, tasks and priorities within tight deadlines.

WORK SCHEDULE / HOURS

The employee is required to work the shift and schedule specified by the Company.

Align Technology



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