Careers That Change Lives
In this exciting role as a Principal Supplier Quality Engineer
the primary focus of responsibility will be supporting Released Product Management (RPM) with supplier management activities.
The Restorative Therapies Group
develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes. A Day in the Life:
Responsibilities may include the following and other duties may be assigned.
Must Have: Minimum Requirements
- Ensures that suppliers deliver quality parts, materials, and services.
- Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness.
- Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur.
- Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met.
- Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.
- Some individuals may have responsibilities that include Pre-Market Supplier Quality and duties may include: Provides Pre-Market Quality Engineering support to New Product Development (NPD) working in partnership with the Component Engineering and Post-Market Supplier Quality Teams, to deliver quality parts, materials, and services, prevent defects, and allow Medtronic to provide customers with the highest quality and reliable products.
- Provides technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle on newly qualified parts from NPD and implementing strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance to applicable industry standards, regulatory requirements, and customer requirements.
- Collaborates with Component Engineers to develop and deliver the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for new products.
- Provide tactical process improvement and change management support to internal processes and external suppliers in resolving quality, productivity, and routine technical issues related to existing products.
- Define Receiving Inspection requirements as required and associated test method validation for all internal Medtronic Test Methods.
- Provide Quality individual contribution and leadership for drawings, specifications, and labeling improvements for existing products.
- Interface with external suppliers including management of supplier corrective actions or to implement supplier changes as appropriate.
- Interfaces with Production, Manufacturing Engineering and Research and Development organizations to integrate new drawings, specifications or processes into the existing manufacturing site/areas.
- Disposition of Non-conforming material requiring advanced process/technical knowledge.
- Lead in resolving discrepancies between manufacturing and quality inspection criteria.
- This person will also ensure that product is manufactured in accordance with applicable industry standards, regulatory requirements, and customer requirements. In the case where corrective action is needed, this person will lead mitigation activities. Conducts training and supervises other engineers and inspection personnel in execution of Quality tasks and production.
- Comply with applicable FDA and international regulatory laws/standards and the Medtronic Code of Conduct.
Nice to Have: Preferred Requirements
- Bachelor's Degree in Engineering, Science or technical field with 7+ years of work experience in Engineering and/or Quality OR Advanced degree in Engineering, Science or technical field with 5+ years of work experience in Engineering and/or Quality
- GMP, FDA QSR, MDD, EUMDR ISO 13485, and ISO14971 knowledge
- ASQ CQE
- Lead Auditor Certification or Training
- Lean Six Sigma Black Belt Certification or Training
- Organized and high level of attention to detail.
- Excellent written and verbal communication skills.
- Experience involving contract manufacturing process, product transfer, facility move, or acquisitions preferred.
- Understanding of engineering principles -focus on mechanical engineering and electrical engineering
- Experience leading and participating in projects/project teams
- Ability to create and work from engineering drawings and/ or specs, including tolerancing.
- Development and qualification of tooling/equipment (IQ/OQ/PQ).
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services 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 exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.
Physical Job Requirements
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. (ADA-United States of America)