Document​/Control Analyst

Overview

We are seeking a Document/Change Control Analyst (official title of the client is Quality Systems Analyst) to work on a team that is onsite in Irvine, CA. This position is W2 hourly with Roth Staffing, with all work taking place at our client facility. No 3rd party candidates can be considered.

• Change control/document control, being able to think critically and problem solve on their own, PLM software (Windchill preferred).
• Summary:
  
  The main function of a quality systems analyst is to support corporate quality strategic initiatives by working with business representatives to understand, and document the business requirements, processes and workflows developing both written and visual depictions of requirements and process flows.
• Partner effectively with all levels of the organization to drive results, proactively identify and resolve problems and escalate as required.
• Work with IT to develop functional specifications and act as Subject Matter Expert for the proposed solutions.
• Work with the Corporate Quality PMO to ensure solutions are successfully developed, deployed and sustained in line with overall Corporate Quality objectives.
• Analyze 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 multi-task and handle variable loads independently within multiple systems (Windchill PLM, JDE).
• High attention to detail and 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 final change package.
• Perform 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 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 course of action after considering 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 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.

• Experience in a quality and/or manufacturing environment in the medical device industry required
• 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

• Bachelor s Degree or equivalent in related field of study
• Experience in a quality and/or manufacturing environment in the medical device industry required
• 5-7 years of experience required

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles  Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance.