Purpose and Passion
At Boston Scientific, youwill find a collaborative culture driven by a passion forinnovation that keeps us connected on the most essential level.
With determination, imagination and a deep caring for human life,we’re solving some of the most important healthcare industrychallenges.
Together, we’re one global team committed to making adifference in people’s lives around the world. This is a placewhere you can find a career with meaningful purpose improving livesthrough your life’swork.
About thisrole :
The Clinical QualityAssurance Specialist position supports the internal clinicalquality assurance program and quality systems for the RhythmManagement division of BSC.
This includes clinical compliance,quality audits, Inspection Readiness program, and, supportingclinical Corrective and Preventative Action (CAPA) and acquisitionintegration.
Your Responsibilities :
Support and mentorsthe Clinical organization in meeting BSC Quality systemrequirements
Participates on clinical projectteams, influences clinical teams toward a state of inspectionreadiness at all times
Communicate with globalclinical teams and Strategic Sourcing regarding new clinical vendorrequests, current clinical vendor needs, and futureneeds.
Review, revise, update and maintainClinical approved vendor list and manages updates to the clinicalvendor audit database.
Plans, schedules, andconducts external quality assurance audits of the clinical vendorsemployed in the design, conduct, and analysis of clinicaltrials.
Documents audit observations; evaluatesimpact and responses to audit findings and ensures the appropriatecorrective actions are completed
Ensurestracking of audit findings
Assists incoordinating regulatory agency sponsor inspections of BSCoffices
Assists in preparation of investigatorsites for Competent Authority or FDA inspections and assists inpreparation of written responses tofindings
Supports the CAPA process, workingcooperatively with Clinical owners providing qualityinput
Contributes to the development and orreview of clinical and clinical quality procedures andprocesses
Participates in problem-solving withteam projects
Assists Clinical QualityAssurance Managers with annual audit planning, review and trendingof audit results, and development and implementation of improvementinitiatives.
May support clinical integrationteams of acquisitions to ensure development and execution of aclinical integration plan, transfer of quality systems, and bestpractices in accordance with Quality project lead integration ofquality system elements.
Supports clinicalteams in gathering and reporting various performance metrics forquarterly BU Management Reviewmeetings.
Whatwe are lookingfor : BasicQualifications :
Bachelor’sdegree in Life Sciences and 6 years of experience or Master’sdegree and 4-7 years of experience
Minimum 6years’ experience in medical device or pharmaceutical industry inan area regulated by GCP regulations and guidelines;
clinical QAand / or compliance experience
Minimum 3 yearsdirect clinical quality (GCP) auditingexperience
Travel up to 50% can be expectedincludinginternational
Medicaldevice experience desired
GCP / auditingcertificationpreferred
Establishesand promotes a work environment that supports the Quality Policyand Quality System.
In all actions,demonstrates a primary commitment to patient safety and productquality by maintaining compliance to the Quality Policy and allother documented quality processes andprocedures.
Assures that appropriate resources(personnel, tools, etc.) are maintained in order to assure QualitySystem compliance and adherence to the BSC QualityPolicy.
As a global medical technologyleader for more than 35 years, our mission at Boston Scientific(NYSE : BSX) is to transform lives through innovative medicalsolutions that improve the health of patients.
If you’re looking totruly make a difference to people both around the world and aroundthe corner, there’s no better place to make ithappen.
BostonScientific is an Equal Opportunity Employer Race, Color,Religion, Sex, Sexual Orientation, Gender Identity, NationalOrigin, Disability,Veteran