Endologix develops and manufactures the latest innovations in endovascular aneurysm repair and sealing. We are a fast-moving, high energy organization. Employees are offered development opportunities and new responsibilities that might have taken them significantly more time in other organizations. Our commitment is to promise the development and refinement of skills while providing competitive compensation and benefits.
The primary responsibility of the Document Control Clerk is to accurately issue, sort, file and store Quality records at the Endologix Santa Rosa site, ensuring timely and efficient access to Quality System and Production information. As time permits, the Clerk also assists in the day-to-day document control process with tasks such as item number assignment, document change order processing, and controlled document distribution.
Receive, sort, log, file, and check out / check in production lot history records and data sheets. Maintain recent records in filing cabinets. Transfer old records to boxes; label and relocate to long-term storage shelving.
Issue and archive engineering builds and laboratory notebooks.
Assist with entering employee training into a database and spreadsheet(s). Assist with creating individual employee files and sort and file training records. Investigate and respond to training-related inquiries. Prepare reports/metrics as needed by manager.
Retrieve quality records requested during an internal and/or external audit.
Assist the Document Control Specialist(s) with document change order (DCO) review / routing / scanning / filing, incorporation of redlines into clean copies, ERP/MES updates, and distribution / archival of master and controlled copies.
Provide instruction to employees, as needed, to promote compliance with the various requirements of Document Services.
Perform other duties as assigned by supervisor.
Ability to accurately and efficiently sort and file documentation by identification number.
Experience with databases, ERP systems, and/or medical device manufacturing preferred.
Prior experience using Microsoft Word and/or Excel (or equivalent) required.
1 2 years' experience in general office support, document controls, records management, or data entry desired.
Understanding of the regulations and regulatory processes (medical/safety/regulatory/corporate).
Experience with electronic document control system preferred.
Experience in cGMP/GDP/GCP environments and FDA regulated industries strongly preferred.
Interpersonal Effectiveness: Actively seeks to understand perspectives and interpersonal needs and expectations of others at all levels, builds self-awareness, flexes personal style appropriately, and works through conflicts constructively and appropriately.
Communication: Effectively uses all mediums of communication as appropriate, presents well to groups, actively listens, and continuously identifies opportunities to build communication skills.
Collaboration & Teamwork: Actively works together with formal and informal team members to build relationships and achieve team goals.
Prioritization: Effectively prioritizes work to ensure timely completion of work within scope.
Global & Systems Thinking: Continuously seeks to learn about and embrace global nuances, works across functions and geographies, seeks to align with diverse groups, and seeks to understand interdependencies and impacts of actions across functions and the company.
Technical Expertise: Continuously builds functional and technical expertise, and pro-actively applies that technical expertise in progressively broader scope.
Continuous Improvement: Learns and uses best practices tools and methodologies to assess, identify, and executes on opportunities to improve; Focus on learning and building new capabilities into self.
Problem Solving & Problem Prevention: Learns and applies problem-solving methodologies and tools, focuses on root cause analysis, and shows orientation towards problem prevention.
Accountability: Focuses on results, takes initiative with minimal supervision, takes ownership for all work within scope, builds relationships and works across departments, functions, or areas of responsibility.
Endologix, Inc. is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity, gender expression, genetic information, marital status, veteran status or any other characteristic protected by applicable federal, state, or local law.
If you are a qualified individual with a disability or a disabled veteran, you have the right to request an accommodation if you are unable or limited in your ability to use or access our career center as a result of your disability. To request an accommodation, contact a Human Resources Representative at Endologix Global Headquarters at 949-595-7200 or Endologix Santa Rosa Facility at 707-543-8800