Careers that Change Lives
In this exciting role as a Quality Systems Program Manager, you will have responsibility for leading Quality Systems and Compliance activities for the Vitatron organization. Specific responsibilities include but are not limited to quality planning, leading Quality Management Reviews (QMR), governing the Vitatron Quality System, assessing and implementing changes to the Quality System, supporting internal and external audits, and leading or participating in CAPA activities.
Our Cardiac Rhythm Management Integrated Operating Unit offers devices and therapies that treat patients with abnormal heart rhythms and heart failure. It is comprised of four key businesses: Cardiac Pacing Therapies, Defibrillation Solutions, Patient Management, and Procedure Innovations. Together, we will transform the lives of people with cardiac arrhythmias and heart failure.
About Vitatron
Our Vitatron organization is part of the Cardiac Pacing Therapies business. It is a Netherlands based international pacemaker company with a rich history and plans for global expansion. Vitatron delivers patient-focused therapies for the treatment of cardiac rhythm disorders: Bradycardia and Atrial Fibrillation.
A Day in the Life
Responsibilities may include the following and other duties may be assigned.
• Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines. Examples include Quality Management Review, Quality Planning, CAPA, and Supplier Quality Agreements.
• Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
• Works directly with operating entities (Cardiac Rhythm Management, Enterprise Functions, and other Medtronic entities) to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
• Leads internal and external audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
• Prepares reports and/or necessary Quality System documentation and provides to applicable stakeholders, both internal and external.
• Ensures the quality assurance programs and policies are maintained and modified regularly.
Must Have: Minimum Requirements:
To be considered for this role, please ensure the minimum requirements are evident on your resume.
• Experience in medical device Quality Systems or Compliance (ISO).
• Advanced knowledge or experience in the European Medical Device Regulation (AIMD, MDD and EU MDR).
• Requires practical knowledge in leading and managing the execution of processes, projects and tactics within one job area.
• Bachelor’s degree in engineering or science.
• Minimum of 5 years of relevant experience, or advanced degree with a minimum of 3 years of relevant experience.
• English (Speaking, writing).
Nice to Have:
• Experience leading Quality Systems activities such as quality planning, management review, CAPA, change impact assessments.
• Experience in supplier quality activities such as supplier selection, quality agreement creation and maintenance, supplier performance monitoring, supplier CAPAs.
• Experience coordinating and planning with internal and external auditing organizations, hosting internal and external audits, responding to non-conformances, and maintaining Notified Body certificates.
• Strong written and verbal communication skills.
• Ability to work and lead independently.
• Strong competencies in judgement and problem solving, especially root cause analysis.
• Working knowledge of RA / QA disciplines, preferred in a medical device environment.
DIFFERENTIATING FACTORS
• Autonomy: Manages one or more small-scale, developed or mature programs with well-defined program plans and delivery methodologies. Is accountable for overall program process, performance, and customer satisfaction.
• Organizational Impact: Provides input to establishing program objectives, timelines, milestones, and budgets. Recommends new policies and procedures that affect program management. May have budget accountability for one or more programs. Program decisions are generally made only after consultation with higher level management.
• Innovation and Complexity: Problems faced are difficult, and require detailed information gathering, analysis and investigation to understand the problem. Problems typically impact multiple workstreams, departments or specialties. Modifies programs management processes to improve program.
• Communication and Influence: Communicates and leads meetings with internal and external customers and vendors, conducts briefings to higher level management team. Solves issues through information exchange, influence and active persuasion without direct exercise of command to gain cooperation of other parties on program execution plans.
• Leadership and Talent Management: Leads, directs and reviews the work of a team of professionals and/or vendors who exercise latitude and independence in their assignments. Direct involvement in daily tasks necessary for successful program execution. Not directly responsible for hire or fire decisions and people management.
We Offer
In our 5th Tenet of our Mission we recognize the personal worth of employees by providing an employment framework that allows personal satisfaction in work accomplished, security, advancement opportunity, and means to share in the company's success.
Also a competitive package is of course part of that. We offer a competitive salary and benefits package to all our employees:
• Flexible working environment;
• Annual Incentive Plan % depending on company results;
• Pension scheme and group discount on healthcare insurances;
• Training possibilities via Cornerstone/Harvard Manage Monitor/GetAbstract;
• Employee Assistance Program and Recognize! (our global recognition program).
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.
Founded in 1949 as a medical repair company, we're now among the world's largest medical technology, services and solutions companies, employing more than 89,000 people worldwide, serving physicians, hospitals and patients in over 155 countries. With our European Operations Center for Distribution and Shared Services in Heerlen, the Bakken Research Center in Maastricht, our manufacturing facility in Kerkrade, and the Dutch sales office in Eindhoven, Medtronic Netherlands has more than 1,750 employees.
Whatever your specialty or ambitions, you can make a difference at Medtronic - both in the lives of others and your career. Join us in our commitment to take healthcare Further, Together.
Additional Information
-Salary Min Not translated: 131,200.00
-Salary Max Not translated: 196,800.00