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Quality Systems Specialist at Medtronic in Mystic, Connecticut

Posted in General Business 30+ days ago.

Type: Full-Time

Job Description:

Careers that Change Lives

Join a Culture of Collaboration and Innovation.
A career at Medtronic is like no other. We're purposeful. We're committed. And we're driven by our Mission to alleviate pain, restore health and extend life for millions of people worldwide.

We reward you in the ways that matter most to you. We offer a wide range of benefits and rewards programs to recognize the important role you play in our Mission to transform healthcare. To learn more, we invite you to visit Medtronic Benefits

We believe that when people from different cultures, genders, and points of view come together, innovation is the result -and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive. To learn more please visit Inclusion & Diversity at Medtronic

A Day in the Life

Are you a passionate, dedicated, and motivated inspector that thrives on directing, organizing, and executing quality projects to improve efficiencies, business continuity and cost?

Come for a job, stay for a career.

In this exciting role as a Quality System Specialist, you will provide support in manufacturing operations including assembly, machinery, processing, packaging, and/or distribution of company products. Reports any malfunctions or abnormalities within the review of critical documentation and equipment/machines, with higher levels recommending and/or making adjustments to methods and processes.

Do meaningful work, make a difference, and improve lives - starting with your own.

ENT (Ear, Nose and Throat) Operations at Mystic, CT

The ENT Operating Unit located a Mystic, CT provides products and services that offer lifelong solutions for the diagnosis and treatment of chronic diseases and disorders of the ear, nose and throat. This position will be supporting Mystic, CT QMS Entity.

Our efforts will have lasting impact on countless individuals and families - it is an opportunity we value and take pride in.

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.
  • 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 (for example Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.
  • Coordinates 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.
  • Collaborates with engineering and manufacturing functions to ensure quality standards are in place.

• Projects may include but are not limited to the following:

  • Ensures that all activities are following Quality System requirements, implement First Time Quality (FTQ) initiatives.
  • May specialize in the areas of incoming material, product sterilization and product final release.

Must Have: Minimum Requirements

To be considered for this role, please ensure the following is evident on your resume:

  • Bachelors degree required
  • Minimum of 2 years of relevant experience, or advanced degree with 0 years of experience

Nice to Have
• Yellow/Green belt certification or equivalent knowledge (Lean/Six Sigma)
• Experience in DHR (Device History Record) review and final product release
• Experience with SAP or other manufacturing transaction system
• Computer literacy. Proficiency in Microsoft Office tools (work, excel, power point)
• Experience in CAPA (Corrective and Preventive Action) and Internal Audit processes

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.

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)

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