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Sr. Quality Systems Manager
Sr. Quality Systems ManagerMedtronic • North Haven, Connecticut, USA
Sr. Quality Systems Manager

Sr. Quality Systems Manager

Medtronic • North Haven, Connecticut, USA
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We anticipate the application window for this opening will close on - 31 Dec 2025

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

A Day in the Life

Bring your talents to an industry leader in medical technology and healthcare solutions were a market leader and growing every day. You can be proud to part of technologies that are rooted in our long history of mission-driven innovation. You will be empowered to shape your own career. We support your growth with the training mentorship and guidance you need to own your future success. Together we can transform healthcare.

Join us for a career in IT that changes lives.

Careers that Change Lives

A Day in the Life

POSITION 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 ensure compliance.
  • Responsible for communicating business-related issues or opportunities to next management level
  • Lead coordination and preparation of internal and external audits resolution of audit and inspection findings and liaise with auditing groups and inspectors through all stages of the audits.
  • Own and drive Investigations Root Cause Analysis and resultant Corrective Actions and Preventive Actions
  • Perform trend analyses and report compliance observations to identify areas in need of improvement
  • Investigates and resolves compliance problems questions or complaints received from other units of the company customers government regulatory agencies etc.
  • Demonstrated knowledge of applicable Quality FDA (Food & Drug Administration) Medical Device Directives / Regulation and ISO (International Organization for Standardization).
  • Excellent writing and editing skills and computer skills.
  • Travel within US and International approximately 25%.

BASIC QUALIFICATIONS :

MUST HAVE : MINIMUM REQUIREMENTS : s

EDUCATION REQUIRED :

  • Bachelors Degree
  • YEARS OF EXPERIENCE :

  • Minimum of 7 years of relevant experience or advanced degree with a minimum of 4 years relevant experience
  • Effective usage of data analysis tools analytical and research skills and problem-solving techniques with keen attention to detail and simultaneous understanding of the big picture. Desire to follow an audit trail to identify risks non-conformances true root cause etc.
  • Outstanding written oral communication and presentation skills
  • Sound judgement ability to make decisions work independently and demonstrated leadership skills
  • Ability to manage and execute on multiple critical projects to manage multiple priorities and escalate issues.
  • NICE TO HAVE

  • 3 or more years relevant experience in a Design & Development and / or Manufacturing setting
  • 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 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.

    DISCLAIMER

    The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities duties and skills required of employees assigned to this position.

    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) : $149600.00 - $224400.00

    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 pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

    The following benefits and additional compensation are available to those regular employees who work 20 hours per week : Health Dental and vision insurance Health Savings Account Healthcare Flexible Spending Account Life insurance Long-term disability leave Dependent daycare spending account Tuition assistance / reimbursement and Simple Steps (global well-being program).

    The following benefits and additional compensation are available to all regular employees : Incentive plans 401(k) plan plus employer contribution and match Short-term disability Paid time off Paid holidays Employee Stock Purchase Plan Employee Assistance Program Non-qualified Retirement Plan Supplement (subject to IRS earning minimums) and Capital Accumulation Plan (available to Vice Presidents and above or subject to IRS earning minimums).

    Regular employees are those who are not temporary such as interns. Temporary employees are eligible for paid sick time as required under applicable state law and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

    Further details are available at the link below :

    Medtronic benefits and compensation plans

    About Medtronic

    We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.

    Our Mission to alleviate pain restore health and extend life unites a global team of 95000 passionate people.

    We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the R&D lab to the factory floor to the conference room every one of us experiments creates builds improves and solves. We have the talent diverse perspectives and guts to engineer the extraordinary.

    Learn more about our business mission and our commitment to diversity here.

    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 addition Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

    If you are applying to perform work for Medtronic Inc. (Medtronic) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

    Required Experience :

    Manager

    Key Skills

    ABAP,Information Technology Sales,Investment Management,Landscape,Maintenance,Clinical

    Employment Type : Full-Time

    Experience : years

    Vacancy : 1

    Monthly Salary Salary : 149600 - 224400

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    Sr Manager Quality • North Haven, Connecticut, USA

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