Title: Quality Assurance Specialst
Location: Dover, NH
Hire Type: 12 Month Contract to Hire
Shift: Monday-Friday, 9-5pm
Compensation: $30-32/hr
Benefits: As a contract employee of Sterling, you are eligible to receive a Full Employee Benefits Package that includes paid time off, paid holidays, 3 medical plans to choose from, dental & vision plans, 401(k), and an Employee Stock Ownership (ESOP) plan.
Job Summary:
Seeking a Quality Assurance Specialist to support quality documentation, document control, and Quality Management System (QMS) activities for an established medical device manufacturer. In this role, you will maintain controlled documents, support regulatory compliance, assist with audits, and ensure quality records remain accurate and up to date. The ideal candidate has experience with quality documentation, SOPs, and quality systems in a manufacturing or regulated environment. Medical device experience is preferred but not required.
Skills:
Experience with quality assurance, quality systems, or document control in a manufacturing or regulated environment
Experience creating, reviewing, revising, and maintaining SOPs, work instructions, and controlled documentation
Understanding of Quality Management Systems (QMS) and document control processes
Knowledge of ISO 9001 or ISO 13485 quality standards preferred
Experience supporting internal/external audits, CAPA, nonconformance reporting, or change control activities
Strong Microsoft Office skills, particularly Word and Excel
Excellent attention to detail, organizational skills, and written communication
Ability to work independently, manage multiple priorities, and collaborate with cross-functional teams
Medical device, pharmaceutical, or other regulated manufacturing experience preferred
Job Duties:
Create, review, revise, and maintain controlled quality documentation, including SOPs, work instructions, forms, and quality records
Manage document revisions, approval processes, change controls, and document retention
Support the maintenance and continuous improvement of the company's Quality Management System
Prepare documentation and assist with internal and external quality audits
Maintain CAPA, nonconformance, product complaint, and corrective action records
Support documentation related to device history records (DHRs), product returns, and quality investigations
Assist with regulatory documentation and compliance activities
Track quality metrics and maintain accurate quality records
Coordinate with Manufacturing, Engineering, Operations, and Management to ensure documentation accuracy and compliance
Support additional quality assurance and administrative activities as needed
Qualifications:
Associate's or bachelor's degree preferred
Approximately 3–5 years of experience in quality assurance, quality systems, document control, or a related field preferred
Experience maintaining quality documentation and supporting QMS processes
Familiarity with ISO 9001, ISO 13485, or similar quality standards preferred
Experience with CAPA, audits, change control, or nonconformance documentation beneficial
Medical device manufacturing experience is a plus, but not required
Proficiency with Microsoft Office and electronic or paper-based documentation systems
Strong written and verbal communication skills
Ability to work independently, maintain accurate records, and collaborate effectively with internal teams
Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or genetic information.