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Senior Supplier Quality Engineer - Osseo, United States - Anteris Tech
Description
Job DescriptionJob Description Salary:
Anteris is a structural heart company delivering clinically superior solutions that help healthcare professionals create life-changing outcomes for patients.
We are currently developing the first-in-class biomimetic TAVR valve as a growing and inclusive Medtech team with global office locations in Minneapolis, MN, US; Geneva, Switzerland; and Brisbane and Perth, Australia.
Help us build a team that will shape the future of TAVR.The
Senior Supplier Quality Engineer
provides technical supplier management leadership supporting the development, commercialization, and on-going supplier relationships to support an implantable medical device system.
This position will be a key stakeholder to ensure robustness in supplier selection, supplier qualification, component qualification, supplier corrective actions and participate in the development of various supply chain strategies.
This person will work cross functionally with Anteris engineers, contract manufacturers, and suppliers to ensure Anteris, and external regulatory requirements associated with purchasing controls, are met and sustained.
This key role will establish the technical purchasing control requirements, and execution will range from consultation to performing critical reviews and completing various supplier quality deliverables.
Primary Duties and Responsibilities:
Execute the supplier and component qualification processes.
Lead supplier management activities, including supplier audits, scorecards, corrective action and change management.
Lead the investigation, permanent resolution, and prevention of supplied component nonconformances.
Review component specifications and proposes changes to existing specifications to support component quality and manufacturability.
Manage development of supplied product inspection procedures, internally and at suppliers, and first article requirements.
Provide engineering guidance to Receiving Inspection including statistical analysis, measurement techniques, and Gage R&R studies.
Assess supplier capabilities through direct visits, technical discussions, and directed testing.
Collaborate with suppliers to develop comprehensive process validation strategies.
Proactively communicate quality issues to suppliers as needed through supplier corrective action requests, data driven and technical discussions.
Drive the development, maintenance, and improvement of quality of components sourced from outside suppliers.
Responsible for contract manufacture's performance and evaluation.
Evaluate and develop control plans, skip lot, dock-to-stock, CoC, and CoA partnerships with suppliers.
Apply thorough engineering analysis and judgement to reduce the need for inspection in accordance to program policies and data gathered.
Work with Manufacturing Engineering to assess and address supplied component issues.Responsible for Supplier Quality activities such as: Supplier Audits, Supplier performance, etc.
Apply systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Participate in or lead teams in supporting Supplier Quality program requirements (e.g., represent the Supplier Quality function as a Core Team Member).
Mitigate risk by work in partnership with the suppliers to document Process Flow Charts, PFMEAs, and Control Plans.Support internal and external audits – including preparation and direct interaction with auditors.
Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.
Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Perform other related duties and responsibilities, on occasion, as assigned.
Required Degree and Experience:
Bachelor's degree in engineering, Physical Science, or related discipline.
5+ years' Supplier Quality experience in a medical device company.
Minimum of 5 years' experience executing New Product Development, Design Controls, and/or developing Design Control Processes in accordance with CFR FDA QSR) and/or ISO
Required Skills and Knowledge:
Experience working with class III medical devices.
Working knowledge of ISO 13485, 14971 and FDA CFR 820 and similar global standards.
Thorough understanding of design controls, risk management, statistics, test method validation, and new product development processes.
Knowledge of product and process verification and validation.
Ability to work as part of a cross functional team.
Ability to define, organize, and manage individual and team tasks.
Effective verbal and written communication.
Proficient in technical report writing and review.
Structured and methodical problem-solving approach.
Foster a positive culture of growth, collaboration, and achievement across the organization.
Ability to travel approximately 15%
Preferred Skills and Knowledge:
Master's degree in engineering.
Working knowledge of ISO 5840.
Membership on the American Society of Quality Control (ASQ) or Society of Reliability.
Good knowledge of statistics, DOE's, process capability calculations.
Experience with JAMA Connect requirements management software.
Strong knowledge of inspection methods in design, fabrication, and production of mechanical components. Demonstrated skill in using test and measuring equipment.
Solid analytical and problem-solving skills, such as six sigma, and statistical applications experience.
Proven organizational and leadership skills. Ability to work under pressure in a fast-paced environment.
Strong oral and written communication skills and ability to interact effectively with all functions within the organization.
Experience writing documents for review by regulatory agencies.
Professional certifications such as, ASQ CQE, Six Sigma or CQA
What We Offer:
Opportunity to make a significant impact on the healthcare industry by advancing groundbreaking therapies.
Collaborative and dynamic work environment with a culture of innovation and excellence.
Competitive compensation package, including salary, performance-based bonuses, and stock options.
Career development opportunities and a chance to be part of a growing company that values its employees.
Health and Wellness Offerings:
Medical, Dental, and Vision Offerings
Flexible Spending Account (FSA)
401k + Company Match
Life, AD&D, Short Term and Long-Term Disability Insurance
Bonus Plan Eligibility
Employee Stock Option Plan
Paid Holidays & Vacation
Employee Assistance Program
Inclusive Team Environment
At Anteris Technologies, we are committed to fostering a diverse and inclusive workplace that encourages innovation and creativity. We value teamwork, integrity, and the pursuit of excellence in everything we do.
If you are a motivated individual with a passion for advancing medical technologies and improving patient outcomes, we encourage you to apply for this exciting opportunity.
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