NeedleTech Document Control Specialist in North Attleboro, Massachusetts
NeedleTech Products, is a leading medical device contract manufacturer located in North Attleboro, MA. We are looking for a full-time Document Control Specialist. If you are looking for your next challenge and have a great attention to detail and a passion for quality, we invite you to apply today.
This hourly position reports to the Director of Quality and Regulatory and is responsible for the administration of the document control system, serving as process owner and ensuring that all quality system documentation and associated logs remain current and available to all users.
To be successful in this role, you will have a strong focus on process improvement, be proactive in your approach, thrive in a team environment and be able to work effectively in a high volume environment while maintaining compliance to quality system regulations.
Work with technical and manufacturing staff to process change notices to release and revise quality system documentation including Standard Operating Procedures (SOPs), Process Instructions, Document Change Control Orders and a variety of technical reports.
Write and prepare original controlled documents for distribution as directed by management.
Coordinate and assist in the review and revision of controlled documents to ensure completeness and coordinating timely distribution of controlled documents.
Maintain logs/lists/catalogs for controlled documents, technical documents/drawings, and master documents requiring routing, signatures, and approvals.
Create original drawings and make technical edits of engineering drawings in SolidWorks.
As a key member of the Quality team, provide support to other quality system processes, such as Training, Non-Conforming Material and Management Review.
THE IDEAL CANDIDATE WILL HAVE:
High School Diploma/GED, Associates Degree preferred
At least 2 years experience in a document control position in a regulated industry (e.g. med device)
Strong understanding of Quality System Requirements (e.g., FDA, ISO 13485, GMP)
Superb organizational skills and keen attention to detail.
Demonstrated technical writing skills (QS SOPs and Work Instructions)
Current experience in SolidWorks and high level of comfort with file management
Proficiency in MS Office Suite, including MS Word, Excel, and PowerPoint.
Excellent written and oral communication skills
BENEFITS AND PERKS
- NeedleTech Products, Inc offers competitive plans for health care and dental, company paid short and long term disability, life insurance, paid time off, 10 holidays, and 401(k) with match.