Description
Job Description:This position is primarily responsible for the Document Services activities within the company including, change control, issuance and obsolescence and training aspects related to the applicable Documentation control regulatory requirements. The position is also the Subject Matter expert for the PLM system.
* Qualifications/Work Experience Required
* 3+ years of experience in Documentation Control, preferably in the medical device industry.
* Working knowledge of ERP, preferably Oracle
* 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
* Ability to influence others
* Strong interpersonal relationship skills
* Excellent computer skills
* Independent judgement skills
* Strong decision making ability Education: Bachelor degree is preferred not required. Previous document control experience is required Job Summary
* This position is primarily responsible for the Document Services activities supporting Fremont manufacturing including, change control, issuance and obsolescence and training aspects related to the applicable Documentation control regulatory requirements.
* The position is the Subject Matter Expert for the PLM system. Essential Duties & Responsibilities
* Support the structural integrity of the implemented Quality System.
* Be the Subject Matter Expert for the Stryker PLM system.
* 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 DMR's, SFP's, 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.
To find out more about Real please visit www.realstaffing.com