Principal Quality Engineer-CAPA and Quality System
Job Description
About the Role
Title: Principal Quality Engineer-CAPA and Quality System
Location: Los Angeles United States
Job Description:
We anticipate the application window for this opening will close on – 14 Feb 2025
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
In this exciting role as a Principal Quality Engineer, you will have responsibility for supporting the CAPA process, change control, and internal/external audit support activities for the Medtronic Diabetes business.
The Principal Quality Engineer is responsible for implementing, maintaining and improving the Quality Management System at the Diabetes sites. Specifically review and revise, as needed, QMS policies and procedures to ensure the work conducted conforms to established corporate and group processes and industry regulations/standards.
This role is instrumental in contributing to defining the direction and plans for process improvement and ensuring the site is audit ready. This role will also participate in external Audits, lead internal and/or supplier audits. The individual in this role must be comfortable coaching all employees on the SR Quality Management System and working professionally with others to reach understanding and agreement, as necessary.
Requisitions This is a hybrid capacity position which requires 3 days in the office and 2 days working in a remote capacity.
A Day in the Life
Responsibilities may include the following and other duties may be assigned.
Quality System Management: Create and revise standard operating procedures, as needed. Perform ongoing gap analysis against requirements and regulations to include routing and release of documentation in Agile and working with managers to assign employee training. Ensure local team is following procedures and the QMS is operating effectively. Update and/or manage Quality Metrics. Assist with Management Review and CAPA Board meeting preparations. Function as the site key compliance contact.
Audit: Assist in preparations for internal and external audits. Lead or participate in audits, as needed. Support external regulatory audits as needed.
Support DHF compliance assessments to ensure quality and regulatory requirements are successfully implemented and maintained.
Corrective and Preventive Action (CAPA) Management: Evaluate, trend and triage issues that may be considered CAPAs.
Communicate effectively and ask the right questions of team members while presenting issues, trends and feedback clearly at CAPA Board Meetings.
Actively track CAPA’s, as needed, and remain diligent to ensure the tasks are completed on time. As needed, assist team in developing solutions to problems via effective means of root cause analysis, and offer possible improvements to processes and systems.
Data Analytics (KPI): Leverage analytical tools to deliver solutions that help solve business problems (Power BI, Power Apps, SharePoint Online, Excel, etc.).
Deliver ongoing reporting & analytics of KPIs to the SR Leadership Team and for CAPA Board meetings.
Must Have: Minimum Requirements
To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.
Bachelor’s Degree and 7+ years of Quality Engineering and/or regulated industry experience
OR
Advanced Degree and 5+ years’ experience Quality Engineering and/or regulated industry experience
Nice to Have
10+ years’ Management Review, Change Control and Audit processes.
Experience with TrackWise software
Working knowledge of 21CFR 820, 806, 803, Part 11, Part 4; ANVISA, TGA, Health Canada, EU, China & Japan regulations; ISO 13485, MDSAP, etc.
Previous experience with effective root cause investigation, corrective and preventive action planning, execution and verification of effectiveness techniques. Experience with quality tools and process improvement techniques.
Experience reviewing technical documentation.
Strong written and verbal communication skills
Strong critical thinking and analytical skills
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):$116,000.00 – $174,000.00
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).
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 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.
