Senior Quality Engineer
Share
Job Location:
Monthly Salary:
Posted on:
8 hours ago
Vacancies:
1 Vacancy
Job Summary
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
Medtronic
At Medtronic we value what makes you unique. Be part of a company that thinks differently to solve problems make progress and deliver meaningful innovations.
Our Purpose
In this exciting role as a Senior 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.
Come for a job stay for a career!
A Day in The Life Of:
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:
- Asist 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 complain 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 email 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 and Quality related information and declarations.
- Assist Medtronic Legal and Quality related input on Customer Agreements.
- Oversee ISO compliance and testing related OEM products.
Key Skills & Experience
- Bachelors degree required wih4 years of relevant experience or advanced degree with a minimum of 2 year 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.
Medtronic offer a competitive salary and flexible Benefits Package
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.
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.
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
Required Experience:
Senior IC
Key Skills
- Quality Assurance
- Six Sigma
- Design Controls
- FDA Regulations
- ISO 9001
- Minitab
- Root cause Analysis
- ISO 13485
- Quality Systems
- Quality Management
- As9100
- Manufacturing
About Company
About Medtronic Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an excit ... View more
