Sr Engineering Change Control Analyst

Job Title:
Sr Engineering Change Control Analyst

Pay Rate:
$63.14/HR.

Duration:
6 months

Location:
Irvine, CA

Our Client is a
Global medical device Manufacturer.

We are looking for a
Sr Engineering Change Control Analyst
to support
medical device design, manufacturing
, and
quality
assurance processes.

• Analyze the varying complexity of changes and resolve issues with collaboration from cross-functional departments.
• Understand
  Product Lifecycle Management
  , ERP, and other
  Change Control processes
  and relationships.
• Able to multitask and handle variable loads independently within multiple systems (
  Windchill PLM, JDE
  ).
• close attention to detail and a robust understanding of
  document control
  and GDP.
• Proactive, quick learner with strong communication and decision-making skills.
• Support and process
  change packages
  against governing procedures, interact with departments to complete the change package, and release the final change package.
• Perform the incorporation of approved changes to
  documentation
  (e.g,
  JDE
  data entry and verify correct implementation)
• Participate in special projects, complete assigned tasks, and deliverables
• Evaluate changes proposed by initiators and provide feedback.
• Other incidental duties assigned by Leadership
• Works independently without close supervision
• Compares and evaluates possible courses of action after considering various possibilities
• Applies his or her knowledge in following procedures, or in determining which procedures to follow, or determining whether specified standards are met
• Considers the cause and effect of activities
• Determines or effectively recommends a course of action after considering the potential risks of alternatives
• May provide guidance to lower-level personnel
• Makes decisions in the face of different alternatives and without formulas or guidelines, or with guidelines that are not complete and exhaustive, and which allow room for creativity and judgment
• Direction tends to be high-level and focused on end results, with means of accomplishment left to the incumbent
• Lead small-scale projects where analysis of situations requires an in-depth evaluation of multiple factors and/or requires an in-depth knowledge of organizational objectives.
• Drive to resolve these issues completely and with speed by leveraging your network of key contacts outside your own area of expertise.
• Drive improvement of current practices and work with the appropriate functions to implement changes or participate in their implementation

Requirements:

• Experience in
  engineering change control processes a
  nd
  documentation
• Experience
  working with
  engineering/manufacturing
  information, including
  BOMs, Drawings,
  and
  manufacturing processes.
• Experience working with a
  PLM
  system;
  Windchill
  experience is preferred
• Experience in a
  quality
  and/or
  manufacturing
  environment in the
  medical device or the pharma industry
  is required
• 5-7 years of experience required

Additional Skills:

• Bachelor's Degree or equivalent in a related field of study
• Experience in a quality and/or manufacturing environment in the medical device industry is required
• Proven expertise in MS Office Suite
• Knowledge of
  Windchill PLM
  preferred
• Excellent written and verbal communication skills, including negotiating and relationship management skills
• Strong problem-solving and critical thinking skills
• Good understanding of
  medical device documentation
  development activities
• Ability to manage confidential information with discretion
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast-paced environment
• Adhere to compliance with internal procedures