The primary responsibility of this position is to establish and maintain a Document Control & Employee Training System capable of meeting regulatory, quality and company requirements for documentation in a medical device design and manufacturing environment
Essential Duties and Responsibilities include the following (other duties may be assigned.)
- Oversee the use of the Electronic Product Lifecycle Management (PLM), Electronic Document Management system (EDMS), and Electronic Learning Management system (ELMS) systems for document control and training ensuring that it is appropriately maintained, supported and effectively used.
- Support Electronic Document System Process Flow development and Data Integrity needs.
- Ensure efficient processing of change orders and documents in the electronic PLM and EDMS systems.
- Ensure that users are trained in the PLM, EDMS, ELMS and that the organization is making valuable use of its capabilities.
- Create and maintain user groups, user assignments, instructor led-trainings, and e-learnings in the ELMS.
- Provide regular updates to the management, on systems, processes and projects; escalate unresolved issues in a timely manner.
- Provide training and guidance in the areas of responsibility for internal customers.
- Manage controlled document and record archiving area and associated electronic systems.
- Coordinate with outside services as needed in obtaining new or revised standards.
- Report monthly metrics on training and change control.
- Drive, track and maintain employee Quality training.
- Responsible for performing all duties in compliance with FDA’s Quality System Regulation (QSR), ISO13485, EUMDR, the Canadian Medical Device Regulations, and all other international regulatory requirements with which the company complies.
- Provide audit support as necessary
- Recognize challenges and escalate in a timely manner to resolve issues.
- Performs other duties as assigned.
- A minimum of 5 years Document Control, Quality, or related experience. Experienced in an FDA regulated medical device manufacturing environment or pharmaceuticals is preferred.
- College degree is preferred.
- Proficient in the use of EDMS and ELMS; experiences with Arena PLM, Veeva, and ComplianceWire are desirable.
- Audit experience preferred.
- Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.Ability to use MS Excel to perform calculations and interpret results/data.
- Good oral and written communication skills.
- Ability to write reports, specifications, and business correspondence.
- Ability to effectively present information and respond to questions from groups of supervisor, engineers and managers.
- Individual must have excellent verbal and written communication skills and a demonstrated ability to communicate clearly and professionally.
- Ability to read, understand and abide by company procedures. Ability to define problems, collect data, establish facts, draw valid conclusions and report on findings.
- Ability to focus on and achieve scheduled milestones, including contingency planning.
- Knowledge of QSR, MDSAP, EUMDR, 13485:2016, and 14971:2012.
- Problem solver.
- Competent using office software including MS Word, Excel, Internet Explorer, PowerPoint, and Outlook.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Type: Experienced