Senior Quality Systems Manager Jobs Vacancy in Medtronic Boulder
Medtronic Boulder urgently required following position for Senior Quality Systems Manager. Please read this job advertisement carefully before apply. There are some qualifications, experience and skills requirement that the employers require. Does your career history fit these requirements? Ensure you understand the role you are applying for and that it is suited to your skills and qualifications.
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Senior Quality Systems Manager Jobs Vacancy in Medtronic Boulder Jobs Details:
Senior Manager Quality Systems
Careers that Change Lives
Lead the Respiratory, Gastrointestinal and Informatics (RGI) organization’s quality system and compliance programs and strategies. Direct the compliance team to ensure the development, communication, implementation and maintenance utilizing best in class quality management principles and tools. Promote continuous improvement of systems, tools and training. Establish and maintain Quality Compliance systems that are in conformance with the US and international requirements.
Lead and manage global external regulatory compliance inspections, responses and action implementation follow up. Facilitate execution of internal audits. Regularly monitor Quality system KPIs, internal/external audit results and other Quality data to identify potential risks and implement necessary actions to mitigate compliance risk.
Build partnerships with the design sites within the RGI global business unit to develop and deploy a harmonized and compliant quality system. Provide expert advice with an overall goal of maintaining a high level of global regulatory compliance. Lead the organization to compliance to global Regulatory Standards by ensuring revisions/new standard requirements are established and implemented within RGI.
Impact patient outcomes. Come for a job, stay for a career.
A Day in the Life
The Senior Manager Quality Systems reports to the site quality leader and manages a team of compliance specialists. This team will work to ensure accuracy in the learning management system, but more importantly work to improve the overall training effectiveness. While the primary focus will be on the design control aspects of the quality management system, this manager will lead improvements across all aspects of the quality management system’s implementation.
Reporting to management on QMS effectiveness through management review will be a periodic task overseen by this position. This manager will coordinate efforts from design centers around the world in topics of corrective and preventative action and risk assessments of identified issues. This position will have the ability to see the progress of their efforts by overseeing the internal audit program.
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 standards and agency guidelines.
Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and agency guidelines to assure compliance.
Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet guidelines.
Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
Co-ordinates legal requests in support of government investigations or litigations.
Ensures the quality assurance programs and policies are maintained and modified regularly.
Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.
Must Have: Minimum Qualifications
Requires broad management knowledge to lead project teams in one department.
Possesses a mastery level knowledge and skills within a specific technical or professional discipline with broad understanding of other areas within the job function.
University Degree and minimum 7 years prior relevant experience; with Masters or other Advanced Degree, 5 years prior relevant experience, minimum of 5 years of managerial experience.
Nice to Have
- Experience with application of FDA and ISO quality standards in a government regulated healthcare industry. Experience with FDA (or Notified Body) inspections.
- Ability to quickly grasp technology, medical applications, and applicable regulations/standards.
- Ability to create and effectively communicate regulations/standards.
- Ability to lead an organization through change to achieve desired outcomes.
- Ability to positively influence groups across an organization to embrace a common philosophy.
- Ability to manage and execute on multiple, critical projects simultaneously. Strong ethics to escalate issues in the face of competing corporate priorities.
- Certified for Lead Auditor, Internal/External Audits.
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 above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Day in the Life 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.
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