Sr. Quality Applications Specialist

About the role

At MiniMed, you can begin a lifelong career of exploration and innovation, while helping make a difference in the lives of people living with diabetes around the globe. You'll lead with purpose, breaking down barriers to innovation for a more connected, compassionate world.

About the Role

Join MiniMed as a Sr Quality Applications Specialist and play a hands-on role in keeping our medical device manufacturing operations compliant, efficient, and patient-focused. You'll tackle nonconformances, drive investigations, support document control, and partner cross-functionally to resolve issues at the source - all in a regulated environment where quality truly matters.

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

• Conducts a compliant validation process for quality information technology systems which requires formal validation documentation (including standard operating procedures) under appropriate federal regulations.
• Coordinates activities with clients, programmers/developers and operating personnel, domestic and, as appropriate, global.
• Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation and maintenance of the procedures, actions and documentation necessary to assure compliance according to the appropriate federal and international regulations which govern the user's applications.
• Reports on the status of validation activities to fulfill regulatory requirements.
• Keeps abreast of changing federal and international regulatory requirements, government audit policies, and the availability of current techniques.
• Performs system administration and configuration of quality information technology systems.

Minimum Requirements

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

• Requires Bachelor Degree
• Requires minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.

Nice to Have

• Experience with Risk management documentation: pFMEAs
• Basic knowledge in statistics (preferably using Minitab)
• Basic knowledge in designing validation strategies (e.g requirements flow down from design to manufacturing)
• Experience investigating manufacturing operations events in support for product disposition
• Experience assessing and tracing manufacturing defects/rejects trends
• Perform and/or review process validation (not cleaning processes) and equipment documents: URS, FAT, IQ, OQ, PQ, TMV (not laboratory)
• Knowledge in Medical Devices regulations
• Experience with projects: design requirements validation, manufacturing controls

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. 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

MiniMed offers a competitive salary and flexible benefits package:

• At MiniMed, we put people first.
• A commitment to our employees lives at the core of our values: We recognize their contributions.
• They share in the success they help create.
• We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every stage of your career and life.

This position is eligible for a short-term incentive called the Short Term Incentive (STI).