Quality Assurance Specialist

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 environmentExperience creating, reviewing, revising, and maintaining SOPs, work instructions, and controlled documentationUnderstanding of Quality Management Systems (QMS) and document control processesKnowledge of ISO 9001 or ISO 13485 quality standards preferredExperience supporting internal/external audits, CAPA, nonconformance reporting, or change control activitiesStrong Microsoft Office skills, particularly Word and ExcelExcellent attention to detail, organizational skills, and written communicationAbility to work independently, manage multiple priorities, and collaborate with cross-functional teamsMedical 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 recordsManage document revisions, approval processes, change controls, and document retentionSupport the maintenance and continuous improvement of the company's Quality Management SystemPrepare documentation and assist with internal and external quality auditsMaintain CAPA, nonconformance, product complaint, and corrective action recordsSupport documentation related to device history records (DHRs), product returns, and quality investigationsAssist with regulatory documentation and compliance activitiesTrack quality metrics and maintain accurate quality recordsCoordinate with Manufacturing, Engineering, Operations, and Management to ensure documentation accuracy and complianceSupport additional quality assurance and administrative activities as needed Qualifications: Associate's or bachelor's degree preferredApproximately 3-5 years of experience in quality assurance, quality systems, document control, or a related field preferredExperience maintaining quality documentation and supporting QMS processesFamiliarity with ISO 9001, ISO 13485, or similar quality standards preferredExperience with CAPA, audits, change control, or nonconformance documentation beneficialMedical device manufacturing experience is a plus, but not requiredProficiency with Microsoft Office and electronic or paper-based documentation systemsStrong written and verbal communication skillsAbility 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.