Job title: senior supplier quality engineer
Location: fridley, mn or remote within us
Careers that change lives
In this exciting role as a senior supplier quality engineer you will have responsibility for management of suppliers within the fridley, mn sqe teamYou 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.
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.
Iv&sh
The intravascular & structural heart (iv&sh) brings our vascular and structural heart businesses together into one cross-functional, collaborative operating network to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe.
A day in the life
Responsibilities may include the following and other duties may be assigned.
Ensures that suppliers deliver quality parts, materials, and services.
Leads cross-functional teams of engineers and manufacturing functions to investigate and resolve supplier-related quality or compliance issues discovered during incoming inspection.
Lead and/or participate in corrective/preventive action teams in resolving supplier-related issues (e.g., nonconformances, capa activities, audit findings, complaint investigations, etc.).
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.
Supports 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 on market-released parts 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.
Develops and delivers the product acceptance sampling strategy, approved supplier list coordination, supplier owned quality deployment, and control plans for existing products.
Evaluates and acts as a lead in processing and approving supplier change requests.
Responsibilities may also include the following and other duties may be assigned.
Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
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 4+ years of experience in quality and/or engineering or advanced degree with 2+ years of experience in quality and/or engineering.
Nice to have
2+ years of supplier quality engineering experience in the medical device industry or related field with supplier quality management expertise.
Asq lead auditor certification.
Working knowledge of quality system regulation (qsr 21 cfr 820) and iso 13485.
Strong written and verbal communication skills in the english language.
Working knowledge of statistical methods associated with six sigma and quality control.
Ability to maintain a professional and respectful relationship with coworkers and company.
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).
About medtronic
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)
Limited travel to suppliers may be required, less than 5%.
