Sr MDR Vigilance Supervisor

Careers that Change LivesThe MDR/Vigilance Supervisor is responsible for the oversight of complaint handling, medical device reporting, and investigation of complaints for Cardiac Rhythm Management (CRM) products in accordance with applicable internal procedures and work instructions, and external requirements (regulations or guidance from any and all regulatory bodies).The MDR/Vigilance Supervisor provides resource coordination and work allocation for team members to meet daily and monthly goals, supports problem solving activities to drive continuous improvement, provides performance management and talent development of team members, and promotes an engaged culture.A Day in the LifeResponsibilities may include the following and other duties may be assigned.

Provide work direction to team members to maintain steady workflow, resource allocation, and productivity to process product experience records in a timely and consistent manner and meet key performance indicators.

Responsible for mentoring, coaching, and developing team members

Prioritize and support strategic and department level initiatives including defining performance goals and targets, conducting performance reviews, individual career development conversations, and regular 1:1s with team members to manage toward achieving department goals

Review and approve timekeeping system entries as needed and vacation requests

Lead regular informational team meetings

Ensure development and implementation of training plans for new hires, and timely training completion for team members

Maintain knowledge of and ensure cell team member adherence to standard work. Refine and enhance standard work to drive effective and efficient product experience record processing

Ensure visual management is adequate and utilized appropriately during daily scrums

Serve as subject matter expert to answer complaint related questions and bring complex complaint files to completion

Escalate issues to management when necessary, including potential resource deficiencies

Ensure work instructions and procedures are in compliance with all applicable FDA regulations, specifically 21 CFR Parts 820 and 803

Maintain regulatory, process and product knowledge to provide internal and external audit support, including front room and back room participation

Prioritize and lead/participate in the assessment and solution development for identified issues of moderate to high scope and complexity including CAPAs, non-conformances, and quality assurance action plans

Proactively support a “stop and fix” culture driving toward timely resolution of issues using problem solving methodologies such as DMAIC

Lead Continuous improvement efforts with work area to improve quality, process and productivity

Promote a culture of inclusion, innovation and engagement, including colleague recognition when appropriate

Collaborate with business partners including Patient and Technical Services, Field Sales, Marketing, Product Analysts, Repair Technicians, Post Market Surveillance and other areas of the business as needed in a professional and customer-focused manner to ensure efficient and effective complaint processing for cell team members

Execute other projects as assigned

Must Have: Minimum Requirements

Bachelors degree with 3+ years of relevant experience, or an advanced degree with 1+ year of relevant experience

Nice to Have

Bachelor degree with 6+ years’ experience in healthcare, medical device, pharmaceutical industry

Complaint handling experience in the Customer Quality (CQ) organization

Ability to work independently or in a team setting

Ability to work well under pressure with a positive enthusiastic attitude

Strong attention to detail

Excellent communication skills (oral and written), with strong organizational and analytical skills

Experience with data analytics/metric report production, and report out to team and leadership

Audit experience

Knowledge of:

21CFR, Section 820, Quality System Regulation

21CFR Section 803, Medical Device Reporting

ISO 13485, Quality Systems, Quality Management Systems

45CFR, Parts 160 and 164, Patient Privacy Rule- HIPPA Regulations

AIMD Directive: 90/385/EEC

MDD Directive (Council Directive 93/42/EEC for Medical Devices)

Knowledge of or experience with problem-solving and process-improvement methodologies

Knowledge of cardiovascular medical device products

High level of computer proficiency (e.g. Microsoft Office, SAP, Siebel, Oracle Clinical, etc)

About MedtronicTogether, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services 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 want to 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.Physical Job RequirementsThe 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. For Office Roles: 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. Contact your manager, recruiter or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefits here (https://www3.benefitsolver.com/benefits/BenefitSolverView?pagename=signon&conum=30601&coaffid=medtronic) .This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) here .The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).Min Salary103200Max Salary154800It 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.