Posted in General Business about 3 hours ago.
Type: Full-Time
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 Supplier Quality Engineer you will have responsibility for management of suppliers within the Plymouth (Nathan Lane, on-site), MN SQE team. You will be accountable for changes to existing supplied products and processes, as well as oversight of performance and improvement activities.
You will also lead the oversight of supplied products, ensuring conformance to purchased materials or finished devices requirements and management of nonconforming product in compliance to Medtronic Purchasing and Supplier Controls, FDA, and international requirements and Quality System Regulations.
Peripheral Vascular Health therapies treat patients with Peripheral and Carotid Artery Disease, End-Stage Renal Disease, Superficial and Deep Venous Diseases, and a variety of conditions treated with Peripheral Embolization. The operating unit leads the way in the Superficial Venous, Deep Venous Stenting, AV Access and Drug-Coated Balloon markets, caring for over 1 million patients globally with lifesaving and life-enhancing therapies.
Our Global Quality Strategy is rooted in the Medtronic Mission and our Quality Policy. Being a 'trusted partner' means always putting patient safety first, upholding product quality, and maintaining the highest ethical standards in our business relationships and programs.
Responsibilities may include the following and other duties may be assigned.
Must Have: Minimum Requirements
To be considered for this role, please ensure the minimum requirements are evident on your resume.
Bachelors degree in Engineering, Science or technical field with 7+ years of experience in Quality and/or Engineering OR Advanced degree with 5+ years of experience in Quality and/or Engineering.
Nice to Have
• 7+ years of supplier quality engineering experience in the medical device industry or related field with supplier quality management expertise.
• Experience with catheter manufacturing, polymer (extrusion, injection molding), metal precision processing, and adhesives for the Catheter/Disposable SQE position.
• Medical device manufacturing industry experience, preferably ISO 13485.
• ASQ CQE, CQA and/or CSQP certification
• First Time Quality Coach (FTQ) / Six Sigma/ DFSS / Lean Green Belt or Black Belt certified.
• Working knowledge of statistical methods associated with six sigma and quality control.
• Working knowledge of Quality System Regulation (QSR) 21 CFR 820 and ISO 13485.
• Lead auditor experience.
• Hands-on experience with SAP, Trackwise, Agile change management.
• Ability to manage tasks and projects under tight deadlines with a sense of urgency.
• Strong written and verbal communication skills in the English language.
• Ability to maintain a professional and respectful relationship with coworkers and company.
• Comfortable navigating through complex networks with diplomatic approaches and reporting to a flattened organization.
• Equipped with sophisticated problem-solving methodologies (Lean/Sigma) and great attention to detail to fit for fast-accurate action-driven environments.
• Engage in changes and advocate for inclusions/diversity.
• Demonstrated working knowledge of supplier controls, process validation, supplier and internal auditing, failure investigation techniques, statistical quality control, protocol/report preparation and non-conforming product controls
• PC skills, MS Office (Word, Excel, PowerPoint and Project).
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):$114,400 - 171,600
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.
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