- 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
- Bachelors degree with 3+ years of relevant experience, or an advanced degree with 1+ year of relevant experience
- 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)
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Sr MDR Vigilance Supervisor - Mounds View, United States - Medtronic Inc.
Description
Careers that Change Lives
The 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.
Responsibilities may include the following and other duties may be assigned.
Must Have:
Minimum Requirements
Together, 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.
Physical Job Requirements
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.
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.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).
