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Senior Document Control Specialist

Company: PROCEPT BioRobotics
Location: Redwood City
Posted on: January 13, 2022

Job Description:

PROCEPT BioRobotics is a publicly held surgical robotics company enabling better patient care by developing transformative solutions in urology. PROCEPT BioRobotics has developed a revolutionary technology called the AQUABEAM Robotic System is the first autonomous tissue removal robot in the world to treat BPH (benign prostatic hyperplasia). Over 1,000 patients have been treated with the AquaBeam Robotic System and we are currently seeking exceptional talent to grow our organization.

Summary

Do you want to be part of an innovative, cutting-edge technology, robotic company that is changing how BPH is treated? Are you looking to be part of an enthusiastic, driven, passionate and challenging team, who continuously learns from one another? Are you looking to make a difference and improve processes? At PROCEPT BioRobotics you will have an opportunity to work with cross-functional teams to maintain and improve the Document Control and Training programs within the requirements of FDA's Quality System Regulation (QSR), ISO 13485 (ISO), and other applicable regulations and standards. Being detail and solution-oriented, proactive, and self-managed will assist in the success of this position.

CORE RESPONSIBILITIES (Other Duties May Be Required As Assigned)

  • Maintain and support all company-controlled documentation as part of the Quality System including hard and soft copies; drawings, specifications, lab notebooks, Design History Files, corrective/preventative action, internal audits, Device History Records.
  • Understand and demonstrate the ability to perform complex document control processes. Act as the company expert and provide end-user assistance in the Engineering Change Order (ECO) processes and of the Product Lifecycle Management System.
  • Act as the Product Lifecycle Management System backup administrator.
  • Analyze document changes for correctness and completeness. Ensure the correct and timely implementation of document control requests. Verify own work, check format and compliance with company templates.
  • Create and maintain document templates, as needed, while ensuring continuous improvement.
  • Recommend improvements in current document control systems, provide written procedures, review, and comment on related documentation procedures, and ensure their proper implementation.
  • Use CAD (SolidWorks) to make simple redline changes to part drawings.
  • Maintain and support training program by initiating and updating training plans in collaboration with managers, as needed, and conducting training sessions, while ensuring continuous improvement.
  • Work on assignments that are complex in nature where judgment is required in resolving problems and making recommendations.
  • Provide recommendations for continuous improvements and supports the implementation.
  • Lead special projects as requested.
  • Maintain external standards library.
  • Provide support and manage back room for internal and regulatory audits and inspections as required (i.e. CA, FDB, FDA, and ISO).
  • Scan and clean documents in preparation for electronic and offsite storage archiving. Maintain the offsite storage program.
  • Work effectively within teams with rapidly changing priorities.
  • May be required to cross-train in other areas with the Quality Department to support workload required, e.g. Supplier Quality, Quality Inspection, CAPA, Complaints.
  • Maintain trained status for, and comply with, all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support regulatory compliance.
  • Understand and adhere to the PROCEPT BioRobotics Quality Policy.
  • Understand and adhere to the PROCEPT BioRobotics EHS Policy.
    QUALIFICATIONS (Education, Experience, Certifications)

    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.
    • 7 + years of document control experience in the medical device industry or related industry
    • Bachelor's degree or equivalent combination of related education and experience required
    • Advanced knowledge and understanding of Document Control standards, practices, and principles
    • Advanced experience and knowledge with databases and Microsoft Suite (i.e. Word, Excel, Visio, PowerPoint, etc.) and Adobe
    • Knowledge and understanding of Quality Systems and applicable GMP regulations and standards
    • Basic working knowledge of CAD (SolidWorks) software
    • Effective written and oral communication skills
    • Effective time management and interpersonal skills
    • Demonstrates ability to perform detail-oriented work with a high degree of accuracy and the ability to multitask
    • Ability to work independently as well as collaboratively in a team environment, including liaising with other departments
    • Ability to work proactively and effectively in a fast-paced, high change environment
    • Flexible; adaptive work style to meet organization needs
    • Demonstrated initiative and resourcefulness
    • Assumes responsibility and accountability for results
    • Committed to self-development and professional growth; solicits feedback from others
      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.
      • To perform this duty the employee must have the ability to sit or stand at and operate a computer terminal and walk or travel safely within the facility.
        Work Environment

        While performing the duties of this job, the employee regularly works in an office environment.
        • COVID-I9 Vaccine Requirement: As of August 19, 2021, all PROCEPT BioRobotics employees must be vaccinated against the COVID-19 virus. The company will follow an accommodation process for medical or religious exemptions.

Keywords: PROCEPT BioRobotics, Redwood City , Senior Document Control Specialist, Other , Redwood City, California

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