Title: Document Control & Change Control Specialist
Hiring Organization: Connexion Systems & Engineering
Compensation, Benefits, and Employment Type
- Duration: direct hire, full time
- Pay rate: $70,000 - $80,000 / year (based on experience)
- Job Location: Danvers, MA
- Schedule: M-F, 1st shift
- Job#: bh19321
Description:
A growing medical device manufacturer on Boston's North Shore is seeking an experienced Document Control & Change Control Specialist to manage and improve its Electronic Quality Management System (eQMS). This is an excellent opportunity for a detail-oriented professional who thrives in a regulated manufacturing environment and enjoys working cross-functionally to maintain quality system compliance.
Position Summary
As the Document Control & Change Control Specialist, you will oversee document control activities, engineering change processes, training documentation, and quality records while supporting continuous improvement initiatives. You'll play a key role in ensuring documentation accuracy, regulatory compliance, and efficient quality system operations.
Responsibilities
- Manage document control processes within an Electronic Quality Management System (eQMS)
- Process Engineering Change Notices (ECNs), deviations, and training records
- Review and approve document control and training workflows for accuracy and compliance
- Investigate documentation discrepancies and resolve missing information
- Monitor workflow status and follow up on outstanding approvals and training assignments
- Support continuous improvement initiatives related to Quality Management System (QMS) processes
- Coordinate manual data transfers between eQMS and ERP systems
- Maintain paper records where required, including Device History Records and training documentation
- Train and support users on document control procedures and eQMS functionality
Qualifications
Required
- 3-5 years of Document Control and/or Change Control experience
- Experience supporting engineering documentation and change management processes
- Strong attention to detail and organizational skills
- Excellent written and verbal communication skills
- Proficiency with Microsoft Office
- Ability to quickly learn new software systems
Preferred
- Experience in medical device, manufacturing, or other regulated industries
- Familiarity with ISO 13485, ISO 9001, or similar quality standards
- Experience with Electronic Quality Management Systems (eQMS)
- Experience with ERP systems
- Knowledge of engineering drawings, Bills of Material (BOMs), and Engineering Change Notices (ECNs)
- Experience with SolidWorks or SolidWorks PDM
- Experience with Propel, Sage, Agile, Windchill, TrackWise, or similar quality/document management systems
Why Apply?
- Competitive salary up to $80,000
- Permanent, full-time opportunity
- Collaborative team environment
- Opportunity to make a direct impact on quality and compliance processes
- Work with advanced manufacturing and quality systems in a regulated industry
If you have a strong background in Document Control, Change Control, Quality Systems, or Engineering Documentation and are looking for your next career opportunity, we'd love to hear from you. Apply today!
You can review our other job postings at www.jobs.csetalent.com.
Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services, while treating candidates with the professionalism and respect they deserve.
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Pay: $70,000.00 - $80,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Disability insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Work Location: In person
