Quality Assurance Analyst II - 1819

Senior Specialist, Quality Assurance (Contract) Braintree, MA | On-site | Contract (approx. 6 months) | $30-40/hr | 7 openings About the Role Be the quality voice on the floor. As a Senior Specialist, Quality Assurance, you'll work with minimal supervision on complex QA activities: reviewing and approving batch records and DHRs, supporting product disposition and release, and providing in-process quality oversight in the cleanroom. You'll also mentor junior QA staff and represent Quality in cross-functional work with Manufacturing, Engineering, and Quality Control.All work is performed in line with QMSR (21 CFR Part 820), ISO 13485, and cGMP requirements. What You'll Do Independently review and approve batch records and Device History Records (DHRs) for compliance and completenessPerform in-process quality reviews and approvals of critical manufacturing steps, and conduct cleanroom observations and risk-based spot checksSupport and coordinate product disposition and releaseProvide advanced support for nonconformance investigations, CAPAs, root cause analysis, and effectiveness checksSupport complaint investigations and post-market surveillanceReview and approve validation and qualification documentation, and support process, test method, and equipment validationsSupport risk management activities, including pFMEA development and updatesWrite, review, and revise quality system procedures, forms, and controlled documentsLead activities in document control, change control, supplier quality, training compliance, and audit readinessCompile, analyze, and present quality metrics, and help prepare Quality Management Review materialsSupport and host portions of FDA inspections, internal audits, and external auditsTrain quality and manufacturing personnel, and mentor and coach junior QA staffDrive continuous improvement of the Quality Management System What You Bring RequiredBachelor's degree in a science, engineering, quality, or related discipline (or an associate degree with equivalent relevant industry experience)5-7 years of experience in Quality Assurance and/or Regulatory ComplianceDemonstrated proficiency in QMSR / 21 CFR Part 820, ISO 13485, cGMP, and Good Documentation PracticesExperience independently performing batch record review, DHR review, and product disposition and releaseExperience supporting nonconformance, investigation, and CAPA activities in a regulated environmentExperience with change control and supporting process, test method, or equipment validationsExperience conducting or supporting internal and external auditsWorking knowledge of Design ControlsProficiency with Microsoft Office and database systemsStrong written and verbal communication, and the ability to work independently and cross-functionallyComfort working in cleanroom conditions and gowning into PPEWhat will help you succeedStrong attention to detail across multiple simultaneous assignmentsOwnership mindset, with sound risk-based decision-makingFlexibility when priorities shift, including additional hours when operations require it Details Location: On-site in Braintree, MAType: Contract, approximately 6 monthsPay: $30-40/hrOpenings: 7 Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions. If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.