Quality Engineer II - Split Shift - On-site at Medtronic in Ann Arbor, Michigan

Job Description:

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
Medtronic MC3, located in Dexter, Michigan, is a key facility within Medtronic's global network, specializing in the advanced manufacturing of medical technologies. As part of Medtronic's mission to alleviate pain, restore health, and extend life, the Dexter site focuses on the production of high-quality medical devices and solutions that are crucial for patient care worldwide. This site operates with a strong emphasis on precision, reliability, and innovation!

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

• Supports continuous product and process improvement through detailed failure analysis for non-conformances, and investigates, develops and implements effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for corrective and preventive actions (CAPA Program). Able to lead, develop, communicate & implement essential containment or corrective actions effectively under potentially stressful situations.


• Assists with continuous improvement projects.


• May process nonconformance reports, deviations, quality alerts and other items


• Utilizes risk management tools and aids for use by the organization in accordance with documented procedures, including but not limited to PFMEA, DFMEA, Fault Tree Analysis, Failure Mode Analysis, etc. Supports design mitigation and process mitigation plans and strategies that are designed to mitigate the risks identified through the Risk Management process.


• Conducts and provides direction for tests and ensures test compliance to test requirements through development, validation, and execution of tests for various other types of products and equipment.


• Develops process improvement plans using a variety of Quality and Continuous Process Improvement tools, including but not limited to Reliability Engineering Analysis, Software Verification and Validation, Accelerated Stress Testing principals, Six Sigma, Lean Manufacturing, 5S, Statistics, engineering studies, Gauge R&R, etc.


• Responsible for management of all controlled documentation within the company. For example: design documentation, training records, lab notebooks, study files, audit reports, SOPs, deviation, training records, product design history file, device history records, CAPA files, NCR files, etc.


• Provides strategic guidance and leadership for document control.


• Supervise document control team.


• Prepares document for editing, verifies document and document attributes conform to established standards.


• Orders document control supplies.


• Assists in supporting internal, supplier and third-party external audits, coordination of activities in backroom and ensuring timely response to document requests from investigators and auditors.


• Supports user requests for documents and trains users in document control.


• Provides support for all departments.


• Participates in QS improvement activities, especially those activities that support the document and data management systems.


• Other duties may be assigned as deemed necessary.


• 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.

Must Have: Minimum Requirements

• Bachelor's degree required


• Minimum of 2 years of relevant experience, or advanced degree with a minimum of 0 years of relevant experience

Nice to Have

• Exceptional analytical, problem solving & root-cause analysis skills.


• Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures)


• Excellent communication skills (written and oral).

• Team player with demonstrated collaboration track record.


• Ability to multi-task & handle talks with competing priorities effectively.


• Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and database applications

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):$76,000.00 - $114,000.00

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).

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 90,000+ 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 law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

At Medtronic, most positions are posted on our career site for 3-7 days.