Quality Assurance Specialist

Job Description

Job Description

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.