1+ months

Quality Systems Program Manager - Drug/ Device Combination Products - Pre-Market Quality (Northridge, CA or Remote within the US)

Northridge, CA 91325 Work Remotely
Quality Systems Program Manager - Drug/ Device Combination Products - Pre-Market Quality (Northridge, CA or Remote within the US)


Northridge, California, United States

Requisition #:


Post Date:

May 09, 2022

**Careers that Change Lives**

A Day in the Life

Responsibilities may include the following and other duties may be assigned.

+ Leads the development of a high performing, scalable, and compliant Quality Management System (QMS) with all relevant drug /device combination product regulations by partnering with key cross functional stakeholders

+ Facilitates and/or supports the development and implementation of medical device and combination product quality governance processes

+ Performs gap assessments of processes and procedures against relevant drug/ device combination product regulations

+ Develops recommendations and proposals to address identified gaps and provides expert guidance on short- and long-term measures to gain compliance, as applicable

+ Update internal product development and design control policies and procedures to accommodate relevant aspects of combination products as applicable

+ Plans, performs, and implements process improvement initiatives (such as Lean or Six Sigma)

+ Maintains current knowledge of external legislation, standards, guidelines, industry bets practices, and FDA submission requirements that impact medical devices and combination products

+ Provides technical contribution to improvements related to all phases of the product development lifecycle

+ Serves as a primary focal point and contact for the Quality function for all combination products QMS related activities

+ Prepares quality reports and leadership communications

+ Manages governance meetings, communicates, and manages risk appropriately

+ Organizes, leads and facilitates cross-functional project teams

+ Develops metrics that provide data for process measurement, identifying indicators for future improvement opportunities

+ May deliver presentations and training courses

+ Surveys and analyzes best practices for techniques and processes

+ Manages changing priorities on projects through effective schedule management and deployment of PM methodologies

+ Participating in support of external and internal regulatory audits, inspections, and responses

Responsibilities may also include:

+ 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.

+ Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.

+ Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.

+ Leads 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 documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.

+ 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 companys mission globally.

**Must Have: Minimum Requirements**

+ Bachelors degree required

+ Minimum of 5 years of relevant experience, or advanced degree with a minimum of 3 years of relevant experience

**Nice to Have**

**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. Lets 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)
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.


Posted: 2022-04-07 Expires: 2022-09-18

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Quality Systems Program Manager - Drug/ Device Combination Products - Pre-Market Quality (Northridge, CA or Remote within the US)

Northridge, CA 91325

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