Document Control Coordinator & Regulatory Compliance Coordinator
Job Description
Schulte Staffing Solutions is partnering with a growing manufacturing organization seeking a Document Control & Regulatory Compliance Specialist to join their team. This position plays a critical role in maintaining quality management system documentation, supporting regulatory compliance initiatives, coordinating audits, and ensuring company processes meet industry standards and customer requirements.
This is an excellent opportunity for an organized, detail-oriented professional with experience in quality systems, document control, and regulatory compliance within a manufacturing environment.
Location: Beverly, MA
Schedule: Monday - Friday, Full-Time
Status: Direct Hire
Salary: 60-65k DOE
Key Responsibilities
Document Control
- Support Engineering, Operations, Manufacturing Engineering, and Quality teams with document control activities and process improvements.
- Administer and oversee document revision and change control processes.
- Create, maintain, and organize document workflows within internal document control systems.
- Develop and maintain forms, templates, procedures, and work instructions.
- Assist with internal and external audits and documentation compliance requirements.
- Maintain employee training records and training database information.
- Issue notifications for pending and overdue training requirements and document reviews.
- Maintain Quality Management System (QMS) documentation and records.
- Support updates to internal quality, engineering, and Return Material Authorization (RMA) systems.
- Ensure regulatory requests are properly submitted and tracked.
- Assist with U.S. and international regulatory submissions.
- Prepare responses to regulatory agencies, customers, suppliers, and internal stakeholders.
- Review quality protocols and documentation to ensure compliance with regulatory requirements.
- Monitor corrective actions, deficiency reports, regulatory requirements, and other quality-related initiatives.
- Maintain awareness of evolving regulations, standards, and compliance requirements.
- Participate in internal audits, supplier audits, and QMS surveillance audits.
- Perform additional duties as assigned.
Required Experience & Skills
- Bachelor's degree or equivalent related experience.
- Experience working within AS9100 and/or ISO 9001 Quality Management Systems.
- Knowledge of document control processes and quality systems administration.
- Experience writing technical procedures, work instructions, forms, and quality documentation.
- Understanding of workflow management and QMS software administration.
- Ability to conduct training and support audit activities.
- Knowledge of regulatory requirements such as:
- REACH
- RoHS
- CMRT
- Proposition 65
- TSCA
- Strong Microsoft Office proficiency.
- Excellent verbal and written communication skills.
- Manufacturing, aerospace, or precision machining industry experience.
- Experience supporting quality assurance and regulatory affairs functions.
- Familiarity with process control and continuous improvement initiatives.
This position operates within a professional office and manufacturing environment and requires regular interaction with cross-functional departments including Engineering, Operations, Manufacturing Engineering, and Quality. Why Apply?
- Direct-hire opportunity with a stable and growing manufacturer.
- Collaborative team environment.
- Opportunity to play a key role in quality and regulatory compliance initiatives.
- Exposure to engineering, manufacturing, and quality systems across the organization.
citizenship, Permanent US residency or classification as a protected individual as defined in 8 USC 1324b (a) (3).
This position is not eligible for immigration sponsorship.
Interested candidates are encouraged to apply today!
Meet Your Recruiter
Julie Kong
Recruiter
Julie joins the Schulte Staffing Team with a proven background in client and team support! Since joining Schulte Staffing, Julie became an integral part of our operations as a branch administrative assistant. After mastering our administrative needs and learning the in's and out's of candidate placement, Julie was interested in a joining our recruiting efforts. Julie always has the candidate and client's best interests in mind.
Share This Job:
Related Jobs:
Login to save this search and get notified of similar positions.About Beverly, MA
Ready to embark on an exciting career journey in the vibrant Beverly, Massachusetts area? Discover a plethora of enticing job opportunities that await you in this charming coastal town, just a stone's throw away from historic landmarks like the Salem Witch Museum and the picturesque beaches of the North Shore. With an array of art galleries, theaters, and parks, as well as renowned seafood restaurants and the beloved Boston Red Sox nearby, Beverly offers a unique blend of culture, cuisine, and outdoor adventures for professionals seeking growth and fulfillment. Dive into our job listings today and unlock your potential in this dynamic and enchanting region!