Description
JOB DESCRIPTION:- Maintain accurate "change control" within the defined quality system, and archiving of obsolete materials.
- Analyze the processing of engineering change orders ensuring accuracy and conformance with approved formats, internal requirements and regulatory standards.
- Lead Document Control activities needed to support manufacturing documentation including but not limited to part, material specification, BOM and router updates.
- Maintenance and storage of documents & data.
- Control of DMRs, SFPs, revisions, and tracking of engineering change orders.
- Effective interface & communication with functional disciplines to ensure efficient and constructive interdepartmental interactions for Documentation and change control aspects.
- Provide training to cross functional groups on PLM and regulatory requirements related to Documentation control.
- Participation in product development team settings for coordination of necessary documentation activities as needed.
- Support & comply with GMP/QSR, ISO 13485 & CE-mark requirements.
- Develop & maintain quality metrics for trending/management reviews.
- Schedule & supervise Document Control maintenance activities, as necessary.
- Maintain an organized, clean, safe & health conscious work environment.
- Assist with company regulatory audit activities, as deemed necessary.
JOB QUALIFICATIONS:
- Bachelors Degree or equivalent combination of education and experience.
- 3+ years of experience in Documentation Control, preferably in the medical device industry.
- Working knowledge of ERP
- Thorough knowledge of GMP and Quality Systems required.
- Strong organization and project management skills
- Ability to work well in a team environment at multiple levels
To find out more about Real please visit www.realstaffing.com