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Medtronic, Inc.

Compliance Specialist

Medtronic, Inc. - Plymouth, MN

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Location:

Plymouth

MN

Date:

11/10/2017

2017-11-10

2017-12-09

Job Code:

35559

Categories:

Government

Healthcare

Medtronic

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Job Details

Job Details

Company

Medtronic

Job Title

Compliance Specialist

JobId

35559

Location:

Plymouth, MN, 55446, USA

Description

Compliance Specialist

Location:

Plymouth, Minnesota, United States

Requisition #:

17000JRB

Post Date:

Oct 24, 2017

**POSITION DESCRIPTION:**

Ensure compliance to Aortic and Peripheral Vascular (APV) Corrective and Preventive Action (CAPA) processes and Medical Device regulations and requirements by working closely with CAPA Board leaders and CAPA Owners in the development of CAPA activities and the rigorous assessment of CAPA documentation.Implement and improve the APV CAPA program including CAPA processes, software systems, reporting of metrics and trends, and training programs.

**POSITION RESPONSIBILITIES:**

Provide rigorous assessment of CAPA activities and documentation to assure compliance with CVG CAPA processes, FDA regulations, ISO 13485, and Medical Device Requirements through the review of CAPA records at critical phases.

Support and guide CAPA Board Leaders and Users regarding the CAPA process, CAPA record content, and CAPA software.Provide APV and CAPA Board Leaders with metrics and reporting on critical aspects regarding the health of the CAPA process.

Support FDA and Notified Body inspection plans as a CAPA Program representative. Activity includes improvement and remediation activities.

Provide guidance in interpreting government regulations, agency guidelines and Medtronic internal policies in general and specific to CAPA to assure compliance.

Support the development and implementation of Quality System CAPA procedures, CAPA software, and CAPA training programs.

Responsible for driving CAPA investigations and effective actions to solve complex issues.

**BASIC QUALIFICATIONS**

**IN ORDER TO BE CONSIDERED FOR THIS POSITION, THE FOLLOWING BASIC QUALIFICATIONS MUST BE EVIDENT ON YOUR RESUME**

EDUCATION:

• Bachelor’s Degree

EXPERIENCE:

• 2 years of quality experience in a highly regulated industry

**DESIRED/PREFERRED QUALIFICATIONS**

Working knowledge of Medical Device and/or Pharmaceutical Regulations.

Medtronic experience working directly with CAPA processes.

Previous work experience working with non-conformances, and corrective and preventive action reports.

Experience with quality tools and process improvement techniques such as Lean Sigma.

Ability to process data and run statistical analysis to root cause, following flow diagrams, and producing process flow maps.

Database system experience (SAP, MRP, CAPA documentation systems such as Trackwise or eMatrix).

Demonstrated strength in the review and writing of technical documentation.

Applied knowledge of effective root cause investigation and verification of effectiveness techniques.

Influence management skills; ability to work constructively across all functions of the organization.

Pro-active, energetic, self-assured professional with high personal integrity and ability to develop good interpersonal relationships.

Strong analytical skills. Reliable and timely decision maker (decisions based on relevant information, alternatives, risk).

Potential domestic and international travel to CVG facilities

**ABOUT MEDTRONIC:**

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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11 days 1 hour ago

Medtronic, Inc.

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Compliance Specialist Medtronic, Inc. - Plymouth, MN, United States

   

Location: Plymouth, MN

Company Profile:
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 Group’s 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.