Manufacturing / Production
Sr Compliance/Audit Spec
Juncos, PR, 00777, USA
Sr Compliance/Audit Spec
Juncos, Puerto Rico, United States
2 days ago
Performs the coordination and/or preparation of internal and external audits and compliance in accordance with regulatory standards (includes FDA and its equivalents outside theUSas well as other government regulatory agencies / authorities).Interprets government regulations as they apply to products, processes, practices and procedures.Implements policies and procedures to ensure that these are in compliance with the appropriate statutes and regulations and ensures that regulatory reporting requirements are met.Investigates and resolves compliance problems, questions, or complaints received from other units of the company, customers, government regulatory agencies, etc.May analyzes audit data and presents findings to management, supports Corrective Action Plans, and provides coaching to business partners.May assists in managing recalls and field actions.May develops and implements programs designed to increase employee awareness and knowledge of compliance policies.
·Manages the facility internal audits program.Coordinates Divisional, Corporate, FDA, ISO, and compliance audits.
·Reviews complaint and failure investigations of our products for adequacy, completenessand compliance to regulations and internal procedures.
·Manages CAPA System activities to assure adherence to internal procedures and regulatory requirements.
·Prepares activity reports.
·Analyzes Quality System data sources to identify adverse trends and critical issues.Elevates appropriately to Management for action.
·Coordinates Management Review and Quality Review sessions in accordance with internal procedures.Issues meeting minutes and follows-up on status of activities.
·Participates in the development and preparation of project plans for quality system activities.
·Ensures compliance with company regulatory compliance programs/procedures.
·Maintains up to date information of new laws and regulations and keep management informed on any changes and their effect in operations.This includes the review of reports received from external sources such as:G.M.P. letter, FDA reports to implement corrective actions.
·Performs other related duties as assigned.
·Reports any observed or informed process and/or product non-conformities to the Supervisor for action and resolution.
·Reports any complaint regarding a Medtronic product to the Supervisor.
·Complies with all the requirements in the operational procedures at the area of responsibility in order to meet the requirements of all applicable Quality System Regulations (e.g.: FDA Part 820 Quality System Regulation, ISO 13485 Quality Standard, R-PAL (Japanese QSR’s).
·Acknowledge and maintain commitment with the EHS Policy.
·Participate in the development of EHS improvement projects.
·Participate actively in the EHS programs to achieve the objectives and targets defined for the area.
·Educational: Science, Engineering , Business Administration or related field
oSenior Level: 5 Years with Bachelors or 3 Years with Masters
·Exposure to quality and manufacturing environment
·Quality and Results Oriented
·Fluency speaking and writing in English and Spanish
·Experience in medical device, pharmaceutical, or electronic industry
·Demonstrate skills and experience in the Qualification / Validation activities.
·Training and experience in quality tools such as; auditing, DOE, SPC, FMEA, Gage R R, ISO/FDA standards and regulations.
·Knowledge of statistics, problem solving techniques and validation of equipment/processes
·Root Cause Analysis
·Technical Writing and Composition
**Mental Components** :
Capacity to calculate, classify, compare, coordinate, copy, edit, evaluate, interview, instruct, read, observe, organize, plan, compile, select, request and document.
**Physical Components** :
Light work requiring physical effort, in addition, requires communication skills, capability to move from one place to another, visual discrimination and tolerance to the use of personal protectionequipment.
Work is performed in building’s interior with normal temperature, good illumination, air condition, clean environment and minimum risk
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Website : http://www.medtronic.com/
Medtronic, Inc. manufactures and sells device-based medical therapies worldwide. The company operates in two segments, Cardiac and Vascular Group, and Restorative Therapies Group. The Cardiac and Vascular Groups products include pacemakers; implantable defibrillators; leads and delivery systems; ablation products; electrophysiology catheters; products for the treatment of atrial fibrillation; information systems for the management of patients with cardiac rhythm disease management (CRDM) devices; coronary and peripheral stents and related delivery systems; therapies for uncontrolled hypertension; endovascular stent graft systems; heart valve replacement technologies; cardiac tissue ablation systems; and open heart and coronary bypass grafting surgical products. The Restorative Therapies Group offers products for various areas of the spine; bone graft substitutes; biologic products; trauma, implantable neurostimulation therapies, and drug delivery devices for the treatment of chronic pain, movement disorders, obsessive-compulsive disorder (OCD), overactive bladder, urinary retention, and fecal incontinence and gastroparesis; external insulin pumps; subcutaneous CGM systems; products to treat conditions of the ear, nose, and throat; and devices that incorporate advanced energy technology. It also manufactures and sells image-guided surgery and intra-operative imaging systems; and provides Web-based therapy management software solutions. The company serves hospitals, physicians, clinicians, and patients in approximately 140 countries. Medtronic, Inc. was founded in 1949 and is headquartered in Minneapolis, Minnesota.