Compliance Audit SpecialistMedtronic, Inc. - North Haven, CT
Manufacturing / Production
Compliance Audit Specialist
North Haven, CT, 06473, USA
Compliance Audit Specialist
North Haven, Connecticut, United States
Oct 27, 2017
**COMPLIANCE AUDIT SPECIALIST**
The Minimally Invasive Therapies Group strives to enable earlier diagnosis, better treatment, faster complication-free recovery, and enhanced patient outcomes through less invasive surgical solutions. From within MITG, you will be supporting the compliance programs for the following business units:
**SURGICAL INNOVATIONS** sets the standard for Minimally Invasive Surgery (MIS) by creating innovative surgical products and services that focus on obesity and diseases and conditions of the gastrointestinal tract, lung, abdominal wall, pelvic region, and the head and neck.
**PATIENT MONITORING AND RECOVERY** focuses on improving outcomes associated with respiratory compromise, deep vein thrombosis, nutritional insufficiency, and healthcare associated infections.
**EARLY TECHNOLOGIES** provide innovative solutions that improve patient outcomes, lower the cost of healthcare delivery, and expand global access to care for cancers and chronic diseases of the GI tract, liver, and lung.
**RENAL CARE SOLUTIONS** strives to improve outcomes, access, and quality of life for patients affected by renal disease.
**Careers that Change Lives**
In this position, you will be an important individual contributor role in the Quality Compliance Group. Primary role is to support the organization’s quality compliance programs and strategies. Promote continuous improvement of systems, products, and services. Establish and maintain QMS systems that are in conformance with international and local requirements. Manage and support the global external regulatory compliance inspections, responses, and action implementation follow up. Support internal audits by acting as an auditor or driving completion of audit actions when required. Analyze and monitor quality data to identify potential high risks and implement necessary actions to mitigate compliance and product risk.
You will build partnerships with the manufacturing sites and provide advice with an overall goal of maintaining a high level of global regulatory compliance. Support global compliance to Regulatory Standards to ensure revisions/ new standard requirements are established at manufacturing sites. Provide guidance to assist in the development, implementation, and maintenance of the Quality Management Systems to ensure the organization functions effectively and efficiently in order to ensure a high level of Regulatory Compliance and to achieve Company goals, objectives, and policies as well as satisfy customer requirements.
**A Day in the Life**
Define, communicate and support for the Business internal and external audit compliance strategy.
Develop cross functional collaborative relationships to facilitate engagement, teambuilding, best practice sharing, critical thinking and innovative problem solving.
Act as Compliance Partner and support operational sites in remediation activities, compliance training, external audits and overall compliance projects/activities.
Support Corrective Action Board and Management Review presentations.
Manage and drive accountability for process improvements at assigned sites or organizations.
Design and lead effective quality processes including procedures, documentation systems, tools, metrics and measurable improvements that are required to meet quality system standards/product approval submission activities.
Support the management of regulatory (e.g. FDA, Notified Body) inspections.
Formulation and execution of remediation efforts resulting from such inspections.
Act as the primary point of contact and provide compliance support to operational sites during FDA and other Regulatory inspections, as needed
Provide expert advice with an overall goal of maintaining a high level of global regulatory compliance.
Support establishment and maintenance of policies and procedures to ensure compliance with the applicable domestic and international regulations/standards, as well as, corporate policies
Support and regularly monitor internal audits and results to identify potential high risk suppliers and implement necessary actions to mitigate compliance and product risk.
Ensure Site audit schedules satisfy requirements tracking/trending audit results; consisting of developing and monitoring audit schedules, conducting audits, review and issuance of audit report documentation and determining adequacy of corrective actions resulting from audit findings and report to Senior Management.
**Must Have; Minimum Requirements**
Minimum 3 years in Quality/Compliance environment for Medical Devices
Demonstrate a clear understanding of regulatory requirements and GMP standards with the ability to effectively implement and communicate FDA and ISO quality standards (i.e. 21CFR820 and ISO13485) in a government regulated healthcare industry.
Experience with FDA and/or Notified Body inspections.
Ability to quickly grasp technology, medical applications, and applicable regulations/standards.
Ability to positively influence groups to embrace a common philosophy.
Strong organizational and leadership skills.
Ability to manage and execute on multiple, critical projects simultaneously.
Strong ethics to escalate issues in the face of competing corporate priorities
**Nice to Have** ;
Certified for Lead Auditor, Internal/External Audits
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers.
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We can accelerate and advance our ability to create meaningful innovations – but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
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10 days 5 hours ago
applyCompliance Audit Specialist Medtronic, Inc. - North Haven, CT, United States
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.
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