Principal Quality Systems Engineer

Medtronic•Lafayette, CO

22h•Onsite

About The Position

At Medtronic, you can embark on a career of exploration and innovation, contributing to healthcare access and equity. This role involves leading with purpose and breaking down barriers to innovation. The Principal Quality Systems Engineer provides oversight for the development and maintenance of quality programs, systems, processes, and procedures to ensure compliance with internal and external standards and regulations. Key responsibilities include offering expertise in policy interpretation, conducting process analyses, leading audit preparations and resolutions, preparing necessary documentation like Corrective and Preventative Actions, and coordinating legal requests. The position also ensures the regular maintenance and modification of quality assurance programs, facilitating uniform standards globally and promoting best practice sharing. This is an individual contributor role, managing large projects or processes, and may involve mentoring or directing lower-level professionals. The role requires significant autonomy, contributing to the direction of new products and processes, solving complex problems, and representing the organization as a primary contact.

Requirements

Mastery of a specialty area and full knowledge of industry practices.
Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A)) and minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.
For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
Possess unrestricted U.S. work authorization at the time of hire and for the duration of employment (U.S. work authorization sponsorship is offered for Principal-level roles and above).

Nice To Haves

Broad knowledge of project management.

Responsibilities

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 company's mission globally.
Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results.
May act as a mentor to colleagues or may direct the work of other lower level professionals.
Coaches, reviews and delegates work to lower level specialists.
Contributes to defining the direction for new products, processes, standards, or operational plans based on business strategy with a significant impact on work group results.
May manage large projects or processes that span outside of immediate job area.
Develops solutions to moderately complex problems, and/or makes moderate to significant improvements of processes, systems or products independently to enhance performance of job area.
Implements solutions to problems.
Represents organization as a primary contact for specific projects and initiatives; communicates with internal and external customers and vendors at various levels.
May negotiate with others to reach understanding or agreement, and influence decision-making.
Typically provides guidance, coaching and training to other employees within job area.
Typically manages major / moderately complex projects, involving delegation of work and review of work products, at times acting as a team leader.

Benefits

Competitive Salary
Flexible Benefits Package
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
Simple Steps (global well-being program)
Incentive plans (Medtronic Incentive Plan - MIP)
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)
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
Paid sick time (for temporary employees, as required under applicable state law)