Quality Systems Manager

Job description

Job Description JOB TITLE : Quality Systems Manager LOCATION : 50 Northern Ave ., Boston, Massachusetts 02210 DUTIES: Collaborate with internal and external business partners and cross-functional teams to resolve complex quality and operational issues, ensuring compliant and efficient solutions. Draft, review, and maintain process-specific Standard Operating Procedures (SOPs) and Work Instructions to ensure they remain compliant and up to date. Analyze workflows, quality systems, and production processes to identify inefficiencies, compliance gaps, and areas for continuous improvement. Develop and implement effective solutions, encompassing enhancements to cross-functional quality systems and operational processes, ensuring adherence to industry standards and regulations including 21 CFR Parts 4 and 820, ISO 13485, and ISO 14971. Participate as a technical resource in cross-functional teams, providing expertise in quality investigations, deviations, and operational issues. Conduct thorough root cause analyses and product impact assessments for investigations resulting from deviations, OOS, or operational inefficiencies, and propose corrective and preventive action plans (CAPAs). Ap...