About this role
This role serves as the most senior plant-level Quality Management Representative responsible for developing and deploying the plant’s quality system and ensuring regulatory compliance procedures are in place. The Associate Director Quality also fulfills PRRC responsibilities, oversees batch review and release, manages Post-Market Surveillance (PMS), and leads quality system continuous improvement and regulatory inspection readiness.
Key Responsibilities
- Act as plant-level Quality Management Representative and manage the Quality organization
- Fulfill PRRC responsibilities including device conformity checks and PMS
- Develop and deploy quality systems (management review, CAPA, design control, process control)
- Direct programs and departments supporting division/company initiatives
- Manage regulatory inspections and handle interactions with customers and regulators on quality
Technical Overview
The technical scope includes operating and improving the Quality Management System with tools/processes such as management review, CAPA, design control, and process control. It also includes PRRC (Person Responsible for Regulatory Compliance) duties tied to device conformity checks, PMS, vigilance reporting under MDR (Articles 87-91), and managing regulatory inspections.
Ideal Candidate
The ideal candidate is an executive-level quality leader who has served as a plant-level Quality Management Representative and is experienced in developing and deploying a Quality Management System. They understand PRRC responsibilities, including ensuring device conformity before release, managing Post-Market Surveillance (PMS), and meeting vigilance reporting obligations under MDR (Articles 87-91).
Must-Have Skills
Most Senior plant level Quality Management Representativedeveloping and deploying the quality system for the plantassuring systems and procedures for regulatory compliance are established and deployedfulfills the role of PRRCmanage the batch review and release activitiesensure Post-Market Surveillance (PMS) obligations are metensure reporting obligation relating to vigilance are met (referred to in Articles 87-91 of MDR)develops and deploys the quality systems (e.g. management reviewCAPAdesign controlprocess control)Manage regulatory inspections
Required Skills
quality management system developmentregulatory compliancebatch review and releasePRRC responsibilitiesPost-Market Surveillance (PMS)vigilance reporting (Articles 87-91 of MDR)management reviewCAPAdesign controlprocess controlregulatory inspectionscontinuous improvementquality organization managementcustomer and regulator interactionsbudget development
Hard Skills
quality management system development and deploymentregulatory compliance systems and procedures establishmentmanagement representative for qualityquality organization managementbatch review and release activitiesPRRC responsibilitiesensuring conformity of devices before releasePost-Market Surveillance (PMS) obligations managementvigilance reporting obligations (Articles 87-91 of MDR)directing large programs and departmentsquality system development and deploymentmanagement reviewCAPAdesign controlprocess controlprocesses to assure conformance to regulationsmanaging regulatory inspectionsexecutive management quality system reviewscontinuous improvement of processes and systemsdeployment of divisional and corporate initiativesquality reliability cost improvementsbudget development for quality organizationproduct quality and conformance responsibilitycustomer and regulator interactions regarding quality of productssystems and processesquality management representative plant level (Most Senior plant level Quality Management Representative)
Soft Skills
leadershipcross-functional collaborationcommunicationstakeholder managementmentoring and building teamsstrategic thinkingdecision makingaccountabilityinfluencing senior management
Keywords for Your Resume
Associate Director QualityQuality Management RepresentativePRRCPost-Market Surveillance (PMS)vigilance reporting obligationArticles 87-91 of MDRMDRmanagement reviewCAPAcorrective and preventive actiondesign controlprocess controlquality systembatch review and releaseregulatory complianceregulatory inspectionscontinuous improvementproduct qualityconformance to regulationscustomer and regulator interactionsquality reliability cost improvementsbudget for quality organizationquality organization
Deal Breakers
Must fulfill the role of PRRC, Must have experience managing Post-Market Surveillance (PMS) obligations and MDR vigilance reporting obligations (Articles 87-91 of MDR)
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