Quality Regulatory Affairs Program Manager

Medtronic   •  

Jacksonville, FL

Industry: Manufacturing

  •  

5 - 7 years

Posted 36 days ago

Careers That Change Lives

The Restorative Therapies Group develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.

SPECIALTY THERAPIES offers a broad portfolio that addresses urologic and gastrointestinal disorders, conditions of the ear, nose and throat, as well as electrosurgical products for soft tissue dissection and hemostatic sealing of soft tissue and bone.

A Day in the Life

Job responsibilities focus on planning, initiating, monitoring, tracking and/or prioritizing business critical projects, process improvement and standardization initiatives by utilizing good project management and/or Lean Sigma. Establish project tasks necessary for successful program execution and help with problem solving and issue resolution. Collaborates and establishes strong relationships with other departments. Recommends new or modified policies, procedures, and processes.

  • · Responsible for organizing and leading complex projects, which include project meetings, publishing detailed minutes consisting of action items and deliverables, developing and updating presentations for projects and program status’
  • · Ensure completion of assigned projects to an agreed upon schedule created by key functional contributors from the team.
  • · Maintain a point of view broader than current role. Consider the needs of the entire organization. Demonstrate global thinking in decision-making.
  • · Actively seek to broaden knowledge and understanding of the business. The ability to influence with other functions and across the business matrix. Consider and effectively respond to diverse opinions, customs, markets and people.

Responsibilities may include the following and other duties may be assigned. ~ Defining, implementing and improving assigned Quality program and governance.

  • Guides the architecture, governance, and measurement of the program.
  • Partners with management to lead quality initiatives that develop and maintain a high performing, scalable, and compliant Quality System.
  • Interprets government regulations, agency guidelines, and internal policies to assure compliance.
  • Partners with Subject Matter Experts to drive development of clear objectives for education packages that improve competency.
  • Establishes meaningful metrics.
  • Prepares quality reports.
  • Consults on development of quality improvements and recommends alternatives.
  • Program management responsibilities may include planning, resourcing, providing status for, resolving issues, and identifying project risks for multiple work streams.
  • Ensures results meet requirements regarding technical quality, reliability, schedule, and cost.

Must Have: Minimum Requirements

To be considered for this role, please ensure the minimum requirements are evident on your resume.

  • Bachelors degree required; Minimum of 5 years experience (related experience including broad multi-functional business experience to include project management experience
  • or Advanced degree with a Minimum of 3 years of experience

Skills/Competencies:

  • · Demonstrated experience in accomplishing project objectives. Able to deliver on multiple projects simultaneously
  • · Oral and written communication skills with the ability to influence all customers (both internal and external) on issues that impact the business
  • · Understanding of data analytics
  • · Excellent decision-making skills, considering all relevant factors and stakeholders
  • · Experience with Microsoft suite of tools (Project, Word, Excel, PowerPoint, etc.)


Nice to Have: Preferred Requirements

  • · Science, engineering, or project management degree(s) preferred
  • · Prior Green Belt or Black Belt certification
  • · Certification as a Project Management Professional (PMP)

Benefits:

Industry-leading Healthcare

Competitive Retirement and Stock Programs

Educational Resources and Financial Assistance

Family Care Leave

Matching Gift and Volunteer Grants

Opportunities to Network and Grow

Mentoring

Flexible Paid Time Off

Well-being Resources, Activities and Rewards

A “Thank-You” Culture



About Medtronic

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. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

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. 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 or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

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