Sr. Customer Quality Engineer

Lafayette, CO
$96,800-145,200 per year
Permanent
Full-time

5 hours ago

We anticipate the application window for this opening will close on - 11 Sep 2025At 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 Sr. Customer Quality Engineer, you will be a close partner of the Acute Care & Monitoring OEM customers. Our OEM customers or Strategic Alliance Partners, who are among the leading Medical Device companies in the world, integrate our products into their devices, and as such they require the highest standards of quality, reliability and safety. In this role, you will have the responsibility for managing a variety of quality activities related to the Acute Care & Monitoring Strategic Alliance customers, including working closely with the R&D group on integration acceptance testing and root cause investigations, working closely with our manufacturing sites to ensure quality controls are in place, communicating with customers concerning quality issues and driving for resolution and continuous improvement, responding to ongoing customers’ requests and inquiries and work closely with the Marketing team to address any customer quality needs.Responsibilities may include the following and other duties may be assigned.

Review test reports supporting Strategic Alliance customers integration acceptance testing.
Review non-product tool validation protocols and reports:

Assist with testing strategies and report formats
Complete risk analysis
Understand Hardware and Software elements
Handle Strategic Alliance Partner complaints and requests for Corrective Actions (SCARs):

Drive root cause investigations and internal actions such as Corrective and Preventive Actions (CAPA), Product and Process Changes (CDPs).
Ensure that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements
Review complaint trends and provide input to Medtronic CQXM (Customer Quality Experience Management) team from a Strategic Alliance customer standpoint
Track of SCARs and reporting of SCAR metrics
Specify inspection and testing mechanisms for material that is non-conforming
Perform statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications
Drive for continuous improvement and updates to processes, templates and documents.
Respond to Quality related questions from Customers via the web Portal or E-mail sources.

Provide information on Materials of Concern.
Provide Certificate of Conformance
Provide technical data to support Strategic Alliance Partner regulatory submission
Support Marketing with the PCN (Product Change Notification) process and customer communication plan.
Assist Medtronic Regulatory Affairs with Quality related information and declarations.
Assist Medtronic Legal with Quality related input on Customer Agreements (Quality agreements, notification agreements, etc.).
Oversee of ISO compliance and testing related to OEM products:

Raising awareness of ISO standard updates, driving for updating test reports.
Providing input to R&D testing as it relates to OEM components.

Must Have: Minimum Requirements

Bachelor’s degree required
Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years of relevant experience

Nice to Have

Project Management experience or training
Experience working with customers
Knowledge with Six Sigma or DRM
Strong analytical and problem-solving skills
Excellent communication skills
Ability to work effectively independently, within teams, and across functions.

Physical Job RequirementsThe 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 & CompensationMedtronic 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):$96,800.00 - $145,200.00This 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:About MedtronicWe 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 95,000+ 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 .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.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 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.

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