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R&D Documentation Specialist II in Irvine, CA at Integrated Resources, Inc

Date Posted: 1/11/2019

Job Snapshot

  • Employee Type:
  • Location:
    Irvine, CA
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:

Job Description

Job Description:

Position Purpose:

Provide documentation support and project coordination for the Core Devices and Pain Management Health Care business sectors. The position has responsibility for all Core Devices and Pain Management products and R&D-owned specification documentation contained within the Compliant Pro and EtQ systems. The position will also provide reporting and analytics support for the Core Devices and Pain Management R&D teams.

Principal Accountabilities:

1. Manage creation of technical specifications for all core devices purchased raw materials. Manage the update of all related ROSUs for all core devices purchased raw materials. Ensure that all elements of the technical specification are accurate and meet defined standards.

2. Support the reporting needs of the R&D sector by providing data gathering and analytics support. Ensure that reporting is accurate, timely, and provides user flexibility and visibility.

3. Identify and pursue opportunities to improve the accuracy and effectiveness of specifications.

4. Communicate fully with superiors, subordinates, and other team members in a manner that is timely, complete, concise and responsive.

5. Contribute to an environment in which all team members are respected regardless of their individual differences and are motivated to improve both their individual and team contributions to achieve desired business results.

6. Actively seek and positively respond to performance and personal development feedback. Initiate and engage in activities to enhance personal functional effectiveness and to realize full career potential.

Qualifications/Education/Experience Required:
Associate's or Bachelor's Degree
A Bachelor's degree in business, engineering or a related discipline, or equivalent working experience in specifications or technical writing of at least 4 years. Must be a strong, technically capable user of spreadsheet and database applications, and possess a systems aptitude with the ability to understand detailed system operations. The incumbent must also be a self-starter and have ability to manage multiple priorities all at once.

Department: Research and Engineering

Purpose of the Position: This individual is responsible for the creation and routing of quality records through, EtQ, the Client Health document control system, working with Research and Development as well as other cross-functional contributors to provide revision control for existing or new documents.

Responsibilities (fundamental job duties):
1. Ensure document control compliance through the preparation, review, and maintenance of Quality Management System Documents. Comply with applicable standards and procedures.
2. Support project teams with technical document routing activity and expedite and drive review and approval, particularly for documents that are urgent or late in the approval process.
3. Coordinate document edit/approval processes to obtain stakeholder input and approval.
4. Support remediation initiatives through cross-functional collaboration and drafting of appropriate design control documentation.
5. Perform other responsibilities, as assigned. Reporting Relationships: Reports to: R&D Manager Positions reporting to this job: None Job Requirements:

Experience Requirements:
Experience with EtQ or similar Document Control platform
Proficiency in Microsoft Excel, Outlook, PowerPoint, and Word
Ability to work independently and be self-motivated with a strong sense of urgency
Efficient and well organized with the ability to effectively establish priorities, and produce accurate work in a fast-paced environment with minimal supervision
Detail-oriented with strong organizational, problem solving, and communication skills (both written and oral)
Ability to work in a team environment including both internal and external resources Other Required Skills and Qualities: N/A Preferred Qualifications:
Two years of experience in the medical device industry
Experience working within the guidance of FDA/ISO Quality Systems requirements
Experience working with IEC 60601 documentation/standards
SharePoint experience

Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job the employee is frequently required to sit and respond to standard desk job demands, stand, and walk.
Must be able to lift a minimum of 15 pounds.
Internal Interface: R&D, Manufacturing, Operations, Marketing, Quality, and Regulatory Affairs
External Interface: Molders, Suppliers, Vendors, Consultants, Machine Shops, Laboratories, etc.