Principal Supplier Quality Engineer
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
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
At our Supplier Quality Department in Medtronic, plc, we partner with Medtronic’s suppliers to deliver the highest quality and most reliable products to our customers within the Diabetes organization.
The Principal Supplier Quality Engineer (SQE) works with a Supplier Quality team who collaborates with external suppliers and cross-functional Medtronic teams daily to resolve supplier-related issues, drive continuous improvement, and manage key quality metrics.
A Day in The Life Of:
* Ensures that suppliers deliver quality parts, materials, and services.
* Provide Pre-Market Quality Engineering support to New Product Development (NPD) working in partnership with Medtronic cross-functional teams, contract manufacturers, and suppliers to deliver quality parts, materials, and services, prevent defects, and allow Medtronic to provide customers with the highest quality and reliable products.
* Qualifies and onboards suppliers according to company standards during NPD pre-production and development phases, ensuring high supplied product yields and reliability.
* Executes validation activities at suppliers to Medtronic requirements ensuring high product reliability and confidence while resolving supplier-related problems as they occur.
* Develops and prioritizes a supplier auditing schedule during NPD to ensure that designated suppliers are audited and onboarded to the Diabetes ASL per Medtronic requirements and 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.
* Builds a collaborative relationship with suppliers to quickly address any issues.
* Drives appropriate root cause investigations with the supplier, ensuring corrective actions are implemented and monitored for desired results.
* Drives supplier improvement/corrective action based on feedback from incoming inspection, Medtronic/supplier internal quality metrics, and customer complaints.
* Coordinates and monitors change control processes (including review and approval) to ensure performance, compliance, and regulatory requirements are met and properly documented.
* Reviews/prepares test plans and reports (qualification, validation) for change and improvement activities (supplier certifications, material/sub-supplier changes, and supplier performed special tests).
* Provides technical assistance to suppliers/other resources performing qualification/validation testing, ensuring resolution of all issues raised during testing/qualification.
* Collaborates with the operating platform to address issues and gain alignment when required.
* Represents the Supplier Quality group in operating meetings providing status updates on supplier base.
* Supports supplier visits or audits as required.
* Supports external regulatory and internal audits as required.
* Works with suppliers and sub-tier suppliers to lead and drive systematic approaches ensuring stability related to medical devices.
* Works with the Enterprise Supplier group supporting the creation of supplier-related metrics for tracking vendor performance and identifying opportunities for improvements.
* Defines Receiving Inspection requirements and associated test method validation where required for internal Medtronic Test Methods.
Key Skills & Experience
* Qualified to Level 8 in Science, Engineering, or relevant discipline.
* 7+ years Engineering and/or Quality experience in the medical industry or related field, or Level 9 degree with 5+ years’ experience.
* Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience.
* Experience with Process Validations and/or Test Method Validations (For Example: IQ, OQ, PQ, and/or TMV).
* May have broad knowledge of project management.
* Dynamic team player who can work effectively and proactively on cross-functional teams.
* Experience with Agile, SAP & Microsoft Project is an advantage.
* Excellent problem-solving skills are desirable.
* Good communicator, fluent in English, both verbal and written.
Nice to Have
* Knowledge of regulatory requirements and guidelines including 21 CFR parts 210, 211, 21 CFR part 820, ICH requirements, and ISO 13485 requirements is an advantage.
* Previous experience in Supplier Quality and leading teams.
* ISO 13485 Lead Auditor Certification.
* Experience with knowledge in Lean Principles.
Medtronic offers 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.
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
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.
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