Job description
Careers that Change Lives
BELLCO, now part of Medtronic in the Renal Care business, is a company, based in Mirandola (Modena – ITALY), leader in systems for hemodialysis and extracorporeal blood purification. Our therapies and systems are employed for the treatment of renal failure, multiple organ failure, sepsis and cardiac decompensation. We are focused on satisfying the needs of patients and experts through: Innovation, Research, Development of advanced Nephrology, Intensive Care and Cardiology Therapies.
As a Sr Supplier Quality Engineer you will be responsible for the management of suppliers within the Design Quality team together with Manufacturing Team with accountability on supporting selection, approval and qualification of suppliers for new products in development.
A Day in the Life
Responsibilities may include the following and other duties may be assigned.
Supplier Selection and Continuous improvement
- Develop a strong relationship with the Suppliers
- Prepare and negotiate Quality Agreements with suppliers
- Apply process development and materials knowledge to component development and quality issues
- Review supplier processes and equipment for optimum output, yield and process stability
- Develop and implement supplier improvement programs, which may lead to certification of suppliers/components
- Recommend and drive continuous improvements in the Supplier Quality organization, to improve the related systems and processes in Medtronic
Technical
- Review and approve changes to Medtronic specifications for purchased materials used in production and manage the supplier change execution process with the supplier in partnership with Sourcing Engineering
- Develop and maintain controls and qualification plans and reports to assure components, materials and suppliers meet specified requirements and performance, reliability goals
- Lead and execute manufacturing process transfers, component/service qualifications and/or product qualifications (CM/OEM).
- Analyze and identify trends from quality data and develop proactive measures with suppliers in support of continuous improvement
- Maintain and Coordinate Medtronic supplier audit schedule and lead or participate in the audit/assessment of current or future suppliers, ensuring they are compliant with associated Medtronic policies and GMP/ISO requirements
- As appropriate, institute appropriate root cause corrective actions relating to production defects and monitors for desired results
- Maintain Medtronic approved supplier files
- Understand and operate to medical device regulatory guidelines (GMP, FDA, ISO13485, AIMD R-PAL) and company Quality System procedures
- Function effectively as part of cross functional and at times cross organizational teams
- Develop strong partnering relationships with Supply Chain, R&D, Operation Quality, and Manufacturing Engineering groups
- Guide the successful completion of major programs and, as required, functions in a project leadership role
Responsibilities may also include the following and other duties may be assigned.
- 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.
- 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.
- Define Receiving Inspection requirements as required and associated test method validation for all internal Medtronic Test Methods.
Must Have
- Bachelor’s degree in engineering, science or technical discipline with
- 4+ years of experience in supplier quality and/or engineering and risk management (PFMEA, DFMEA).
Nice to Have
- 4+ years of supplier quality engineering experience in the medical device industry or related field with supplier quality management expertise.
- ASQ CQE certification
- ASQ Lead auditor certification
- Manufacturing processes or R&D experience
- 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)
- Advanced use and understanding of statistical tools
- Working knowledge of Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), and ISO 13485
Additional Information
- Work location: Mirandola (Modena – ITALY)
- Travel: 25% (mainly Italy and Europe)
About Medtronic
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)
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