Careers that change lives
In this exciting role as a senior supplier quality engineer, you will be responsible for the management of our strategic contract manufacturers (cms) and original equipment manufacturers (oems) at medtronic, with accountability to support changes to existing supplied products and processes, as well as oversight of performance and improvement activitiesWhile partnering with our cms and oems, including sub-tier suppliers as required, this position is responsible for maintaining necessary controls and drive improvements relating to finished medical device / component quality in conjunction and within our suppliers’ quality systems.
You will work in partnership with the internal medtronic r&d, quality, and regulatory teams, to deliver ensure our supplied products conform to finished device requirements, prevent defects, and allow medtronic to provide customers with the highest quality and reliable products while staying in compliance to applicable industry standards, regulatory requirements, and customer requirements.
Our global quality strategy is rooted in the medtronic mission and our quality policyBeing a `trusted partner` means always putting patient safety first, upholding product quality, and maintaining the highest ethical standards in our business relationships and programs.
A day in the life
Responsibilities may include the following and other duties may be assigned.
Work with medtronic’s strategic cm/oem suppliers to lead and drive systematic approaches to medical device quality issues.
Drive corrective/preventative actions at our cms/oems based on feedback from incoming inspection, production defects, medtronic/supplier internal quality metrics and customer complaints.
Work with sub-tier suppliers, as required, to lead and drive systematic approaches and ensure stability related to medical device quality.
Coordinate and monitor change control process (including review and approval) to ensure performance, compliance and regulatory requirements are met and properly documented.
Oversee changes to processes/products currently in production to aid in the correction of process, design or material problems (as well as changes associated with sub-supplier and material changes)Lead quality process improvements and streamlining activities.
Lead work with production areas to implement quality-based improvements to current products and manufacturing processes.
Review/prepare test plans and reports (qualification, validation) for change and improvement activities (supplier certifications, material/sub-supplier changes and supplier performed special processes).
Provide technical guidance and quality compliance to suppliers/other resources performing qualification/validation testing.
Ensure the resolution of all issues raised during testing/qualification.
Instrumental in the development and implementation of systems and processes for cm/oem supplier management that are in compliance with corporate policies and industry standards/regulations and other quality requirements and guidelines.
Supports corporate and external (fda, tuv, bsi, etc.) quality and compliance audits of the cm/oem products and/or the supplier’s quality management system.
Provide statistical support by the creation of supplier related metrics for the purposes of tracking vendor performance and identifying opportunities for supply chain improvements.
Support / lead sustaining engineering projects that may involve manufacturing process transfers, label/ifu updates, sub-supplier qualification, performance testing (verification and validation), and design qualification.
Participate in the audit/assessment of current or future suppliers/contract manufacturers ensuring they are compliant with associated medtronic policies and gmp/iso requirements.
Position can be remote
Must have: minimum requirements
To be considered for this role, please ensure the minimum requirements are evident on your resume.
Bachelor’s degree in engineering, science or technical field and minimum of 4+ years of relevant experience in engineering and/or quality or an advanced degree in engineering, science or technical field with 2+ years of experience.
Nice to have ( preferred qualifications )
4+ years’ experience in medical device and/or capital equipment
Demonstrated working knowledge of supplier controls, process validation, failure investigation techniques, nonconforming product controls, and protocol/report generation
2-4 years’ experience supporting internal or external manufacturing processes across multiple areas, including, but not limited to: printed circuit board assembly, manual assembly, machining, molding (dip/injection), etc.
Project management experience
Quality system lead auditor experience (iso 13485)
Use and clear understanding of statistical tools (design of experiments, measurement system analysis, process capability and statistical process control)
Superb oral and written communication skills
Ability to work in a team/partnership environment
Computer skills (microsoft word, excel, project, powerpoint; trackwise; agile)
Together, we can change healthcare worldwideAt medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend lifeWe challenge ourselves and each other to make tomorrow better than yesterdayIt 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 teamLet’s work together to address universal healthcare needs and improve patients’ livesHelp 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 jobReasonable accommodations may be made to enable individuals with disabilities to perform the essential functionsFor office roles: while performing the duties of this job, the employee is regularly required to be independently mobileThe employee is also required to interact with a computer and communicate with peers and co-workersContact 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)
Ability to travel up to 15%
Posted 30+ days ago