At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

As the Senior Quality Systems Manager, you will play a critical role managing all elements of Operations Quality for the AST Focus Factory, including but not limited to: D2D quality support to manufacturing lines, NCMR & CAPA execution, QMS and Compliance AST area specifics elements, capacity expansion project support (new lines), NPD introductions.

This position manages two Operations Quality Managers and a total of eight Quality Engineers. There are shifting project funded resources managed by the role through contracts.

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

• Plans, directs and implements all aspects of the company's design and development of new medical device products or software systems.
• May develop, evaluate, implement and maintain technical quality assurance and control systems or reliability systems and standards pertaining to materials, techniques, or company products.
• Oversees the investigation and evaluation of existing technologies.
• Guides the conceptualization of new methodologies, materials, machines, processes or products.
• Directs the development of new concepts from initial design to market release.
• Manages feasibility studies of the design to determine if capable of functioning as intended.
• Monitors documentation maintenance throughout all phases of research and development.
• Organizes the coordination of activities with outside suppliers and consultants to ensure timely delivery.
• Selects, develops and evaluates personnel to ensure the efficient operation of the function.

Required Knowledge and Experience: Requires broad management knowledge to lead project teams in one department.
Typically has mastery level knowledge and skills within a specific technical or professional discipline with broad understanding of other areas within the job function.
Requires a Baccalaureate degree and minimum of 7 years of relevant experience with 5+ years of managerial experience, or advanced degree with a minimum of 5 years of relevant experience with 5+ years of managerial experience.

Preferred Qualifications:

Experience with suture components including needles

Knowledge of the finished goods focus factories

Excellent understanding of operations, quality engineering, quality management systems and compliance

Experience supporting the day to day activities of running manufacturing lines, quality investigations, CAPA's

Understands regulations ISO 13485

Excellent collaboration cross functionally, ability to influence

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 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.

Benefits & Compensation
 

Medtronic offers a competitive Salary and flexible Benefits Package
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.
 

Salary ranges for U.S (excl. PR) locations (USD):$168,800.00 - $253,200.00

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

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 pertain