Senior Manager Quality Systems

Position Overview

TheSenior Manager, Quality Systems willbe responsible for the governance, and execution of the Quality ManagementSystem at the Norwood, Ma (Edgewater) facility within the Point of Care (POC)business. Specifically, you will maintain and oversee all aspects of theQuality Management System. This includes responsibility for the Quality Systemsteam of Engineers, ownership/oversight of CAPA, document control, internal andexternal audit, non-conformance, product-related environmental protection(PREP), supplier quality and training processes, as well as overall auditreadiness. The Senior Manager is expected to drive qualityKey Performance Indicators (KPI) metrics and report results to management.

Additionally,this role will lead and/or oversee specific quality improvement projects, asrequired, to support QT and other business initiatives including, but notlimited to, leading Edgewater site external audits, managing the POC internalaudit program, leading the POC TRSM program, and driving change within the POCQMS. The individual in this role is expected to act as a change agent, applyadvanced problem-solving techniques and interpersonal skills and be able toinfluence and drive results.

Responsibilities

• Lead external audits for Edgewater facility, including execution of audit readiness activities and coordination of audit logistics with SMEs
• Provide strategic oversight of all QMS processes and initiate changes, as applicable
• Lead the POC wide internal audit program
• Lead the POC wide TRSM program
• Support the development, monitoring and reporting of key performance indicators (KPIs), which will include assisting in the development of Quality Goals & Objectives across POC

·       Experience with managing complex issues with potentialfor significant business impact

·       Exceptional attention to detail with strongorganizational and technical skills

·       Advanced knowledge of FDA regulations, EU IVDDirective and new IVD regulations, pertaining to Quality System regulation(e.g. ISO 13485:2016)

·       Strong leadership skills

·       Experience in lean methods like Six Sigma, Agile orBusiness Systems for operational excellence

·       Strong analytical skills and data driven mindset

·       Must manage multiple projects simultaneously

·       Must have strong written and verbal communicationskills, including presentations to senior management

·       Key leader during site audits including directinterface with investigators

Required Knowledge/Skills, Education, and Experience

BS/BA inrelated discipline, or advanced degree (preferred), or equivalent combinationof education and experience

Minimumof 10 years of successful management experience in Quality field. Experiencewith FDA Quality System Regulations and audits.

Travelmay be up to 10% for this position 

Preferred Knowledge/Skills, Education, andExperience

Additional expertise inQuality Systems and/or Quality Assurance is a plus as this role is ahigh-ranking position within the QT team at POC.