RCM Technologies Quality Systems Manager in Bedford, Massachusetts
Reference # :17-00944Title :Quality Systems ManagerLocation :Bedford, MAPosition Type :Direct PlacementExperience Level :Start Date :09/29/2017 Description
JOB DESCRIPTIONTitle of position:Quality Systems ManagerDirect Reports: YesLocation: MaPosition SummaryResponsible for the development and implementation of programs thatwillassess, integrate and manageQuality System elements within the facility. Establish and maintain programs in compliance with medicaldevice, IVD and related domestic and international regulations. Supports multi-disciplinary functionsinmeeting quality and regulatory compliance requirements for our Clients systems, i.e. CE, CSA, EuropeanDirectives, Environmental, to meet worldwide regulatory requirements.Key Accountabilities:
May fulfill the role of the Management Representative to ensure that processes needed for thequality and environmental managements system are established, implemented and maintainedand report to the Management Review Committee (MRC) on the performance of these systemsfor their review and action, including recommendations for improvement.
Participates as an EDMA (European Diagnostic Manufacturers Association) member inDiscussion Forums to access information at an early stage on major EU regulatory issuesessential for strategic planning.
Manages projects to improve the quality system for compliance, efficiency or changing requirements due to Regulatory changes or organizationalIgrowth needs.
Assures that systems of responsibility are managed appropriately, provide added value to theorganization and are in compliance with the local and international standards and regulations.
Monitors the health of the Quality System through identification of key metrics. Reports on themetrics at regularly schedule meetings.
Develops full project plans for each approved area of integration; reports to upper management.
Manages the internal audit system and the corrective/preventive to ensure continued complianceto domestic and international regulatory regulations.
Manages the change order system to ensure continued compliance to domestic and international regulatory regulations and meet production requirements.
Establishes and coordinates the site quality system training program to ensure that new personnel are trained to the cGMP and ISO requirements specific to their job responsibilities and that the existing personnel base is reviewed annually for additional training needs due to changesin the regulations and to foster continuous improvement.
Manages the quarterly cGMP training system and implementation of alternate trainingmechanisms for a layered training approach.
Maintains our Client's CSA Category Certificate Program or the Material Safety Data System. Interfaceswith CSA to create and maintain our instrument safety certification. Performs monthly audits tosupport safety program and reviews all changes for impact to our certificates from CSA.
For Bedford only, ensures that our Client's instruments meet requirements specified by the EuropeanDirectives for safety, emissions, immunity and packaging. Coordinates in-house and outsidetesting to certify that instruments meet those standards. Controls QA files to support CE testrequirements for instruments.
Audits and evaluates Suppliers on an ongoing basis, maintaining an approved supplier list. Works with a team (purchasing, engineering and manufacturing) to support manufacturing goals.
Quality System Management of: CAPA, Internal and Supplier Audit Programs, Change Order,Metric preparation, Labeling and Translations,DHFAudits, Record Retention, QS Training.
Budget managed (if applicable)N/AInternal Networking/Key relationships
- To be determined based on department needs
Skills&Capabilities:Functional/technical skillsOral and written communication skillsMin Knowledge & Experience required for the position:Minimum of Bachelor's Degree, in related scientific or technical fieldMinimum of 1 year of experience in the medical device industry,with2yearsin qualitymanagement.Knowledge of cGMP,FDA and ISO regulationsAuditing experience requiredInternational Mobility:Required: noTravel requirements:Available to travel up to two days per month on average