Headquartered in San Jose, California, Align Technology is the leader in modern Clear Aligner orthodontics that designs, manufactures and markets the Invisalign® system, which provides dental professionals with a range of treatment options for adults and teenagers. Align also offers the iTero 3D digital scanning system and services for orthodontic and restorative dentistry. Align is one of the fastest growing medical devices companies in the APAC region. The company is entering an extremely exciting but critical phase of development. Align is investing in new capacity, capabilities, and infrastructure in the region to build foundational platforms, systems and processes to accelerate the region’s growth.
APAC Documentation Control Lead
jobsDB Ref. JSG400003003033050
The APAC Documentation Control Lead supports the creation, revision and control of Quality documents and records needed to ensure that development, manufacture and distribution of medical device products is in compliance with Align policies, US FDA regulations, ISO 13485, and all other applicable requirements of other global regulatory bodies. The APAC Documentation Control Lead must work independently, without direct supervision, and make decisions using his or her own judgment. In addition, they must have excellent organizational skills and in-depth knowledge of electronic documentation systems, the ability to train others in the applicable electronic and paper based systems, and to conduct Change Order training if requested. The APAC Documentation Control Lead must also be able to multi-task, work well in a fast paced professional environment, be detail oriented, and have the computer skill level to create master documents, i.e. templates, forms, logs, etc. This individual must possess a high level of computer literacy and knowledge of various software programs.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Implement document control processes for APAC and ensure global consistency/alignment. Act as a point of contact and managing priorities.
Ensure that site document control procedures comply with local/country specific regulations as well as internal policies and procedures. While the expectation is to use the global procedures, local regulations may require the development of site procedures. Additionally, any translations of documents must be controlled.
Be responsible for maintaining the APAC change control process in Arena, including the review of change control documents and deliverables.
Coordinate with other functional areas to ensure accurate, complete and efficient change control processing.
Review and assist in resolution of documentation issues (e.g., change control, document archiving, procedures, etc.) and translations.
Review all electronic documents submitted to change control for correct formatting, spelling, and clarity of text before routing for approval.
Maintain applicable forms and templates.
Track, follow-up regarding, and implement change control records.
Co-administration of Arena PLM documentation system.
Interface at all levels with all departments to service their requirements in an efficient professional manner.
Create and maintain all hard and soft copy project files for active and archival documentation.
Function as a contact person for international documentation issues and work collaboratively with Document Services based in US Headquarters.
Assist with all department projects as required.
Participate in proactive team efforts to achieve departmental and company goals.
Develop and maintain site Quality System policies and procedures to comply with corporate and/or local QMS requirements. Coordinate with site personnel to ensure the success of site audits. Drive closure to audit findings including investigation, implementation, and effectiveness checks.
Work collaboratively with site process owners to define improvements.
Develop and maintain site CAPA activities including: investigation, root cause analysis, propose implementation plans, and effectiveness verification.
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, skills, and/or ability necessary for this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Strong oral and written communication skills
- Strong computer skills.
- High ability to communicate and interact with customers of various education levels with diverse cultural backgrounds.
- Excellent organizational skills.
- Demonstrated ability to manage time effectively, prioritizes multiple requests, and meets deadlines
- Ability to efficiently create, edit, and format Word, PowerPoint, and Excel documents.
- Proficient in the English language
EDUCATION and EXPERIENCE:
- 4-6 yrs. experience in Quality Documentation/Engineering role at a medical device company
- Familiarity with ISO and FDA standards. Experience in Quality Assurance role is preferable.
- Excellent advanced Computer skills in Microsoft Word and good skills in Excel, PowerPoint required.
- Working knowledge of other specialized programs such as Visio, Illustrator, Photoshop or Acrobat desired, not required.
- Knowledge of Arena or Agile PLM systems a plus