Senior Quality Engineer - ENT
Senior Quality Engineer - ENT
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$ 96800 - 145200
1 Vacancy
Job Description
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
Careers that Change Lives
Our space the medical device and healthcare industry is rapidly changing. It always has been that way. Agility and responsiveness are critical to our success with remote monitoring wearables robotics AR/VR telemedicine and more. Experience what its like to work at a company with an exciting product pipeline of patented inventions driving innovation in the healthcare space.
The Ear Nose and Throat Operating Unit is a global leader and trusted partner for innovative ENT solutions that improve patient access outcomes and customer satisfaction. We partner with the ENT community to understand the needs of customers and patients delivering solutions that will enhance lives as we embody a culture of accountability and trust.
Over the past 20 years we have become the global market leader in three key segments image-guided surgery intraoperative nerve monitoring and powered surgical instruments. We continue to launch valuable ENT solutions in tissue health and balloon sinus dilation.
Responsibilities may include the following and other duties may be assigned:
Support the development of investigation guidance and technical analysis of product complaints ensuring timely resolution and consistency in supporting documentation and reportability decisions.
Investigate and bound product quality issues for containment and corrective action.
Support the development and maintenance of risk management/ complaint analysis procedures to support business efficiency in alignment with applicable regulations.
Lead or support updates to product risk management files based on post-market data in alignment with ISO 14971:2019 and applicable regulations.
Perform advanced analysis of quality data (including complaints CAPA and post-market surveillance) using tools such as Microsoft Excel Power BI VBA and statistical methods to identify trends drive root cause investigations and support data-driven decision making.
Support and organize responses to regulatory inquiries about post-market quality data.
Prepare and participate in internal and external audits in the areas of risk management and post-market regulatory compliance.
Support activities from CAPAs audits quality plans or other regulatory commitments.
Must Have: Minimum Requirements
Bachelors degree in Mechanical Engineering Electrical Engineering Computer Engineering or a technical field.
Minimum of 4 years of Quality Engineering experience or advanced degree with a minimum of 2 years relevant experience.
To Be Successful in this role:
Experience in the medical device in-vitro diagnostics or pharma industries
Strong knowledge of ISO 13485/FDA 21 CFR Parts 803 806 820 and ISO 14971
Experience in analyzing quality data and driving root cause determination
Experience with statistics and statistical techniques as it applies to sample size determination trends risk management related calculation such as P1 and P2 etc.
Experience with project/program management
Nice to Have
Experience in automation and data analysis tools such as Microsoft Excel VBA Power BI
Experience in test automation and with statistical process controls
Black Belt or Master Black Belt certification
Experience with statistical process controls
Must be self-motivated to complete assigned tasks on time.
Must be able to multitask on several assigned projects/assignments
Strong communication and presentation 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.
The following benefits and additional compensation are available to those regular employees who work 20 hours per week: Health Dental and vision insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition assistance/reimbursement andSimple 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 matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-qualified Retirement Plan Supplement (subject to IRS earning minimums) andCapital 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 findhere 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:
Senior IC
Employment Type
Full-Time
