The Operations team partners closely with ResMed's five business leaders to understand their needs then providing a variety of products and services to help them meet those needs including Customer and Technical Services, Global Quality Assurance and Regulatory Affairs, Supply Chain, manufacturing, logistics and distribution. Focused on enabling new product introduction and operating excellence, our team strives to improve time to market for new products and services, improve efficiencies in our cross-functional processes, and improve our supply chain through digitization and automation to increase value add to our customers.
Let's talk about the team and you: The primary role of the Manufacturing Quality function is to design, implement and monitoring quality control programs. We ensure that products are built correctly to specification, quality standards and appropriate regulatory compliance. As a Supplier Quality Engineer, you will be responsible for identifying, resolving, organizing and executing opportunities related to improving the quality of purchased material. This function drives the supplier quality assessment, performance and development activities required to assure the delivery of high quality materials and services.
Let's talk about Responsibilities:
Performs to individual Key Performance Indicators (KPI's) established during performance reviews and/or goal setting meetings.
Coordinates activities with Quality to establish programs for qualifications and monitoring of supplier and supplier processes.
Perform supplier process audits (FMEA, Control Plans, SPC data).
Ensures quality measures with associated suppliers are established and maintained for the supply chain quality performance.
Lead suppliers through a basic problem solving and corrective action effort using a disciplined step-by-step process (e.g. Define the problem, Interim action, Possible / Actual cause, Solution / Verification, Prevention).
Provides support to manufacturing and materials department by ensuring purchased parts meet quality and reliability requirements with the lowest total cost ownership by performing the following duties.
Continuously work to improve the processes and systems that facilitate the conversion of purchased parts and raw materials into value added products for our customers.
Interface with materials, engineering and operations personnel regarding quality issues and corrective actions.
Assist with Materials Review Board related to supplier quality. Analyze non-conforming material historical information for opportunities to prevent/improve product quality.
Continually drives the utilization of advanced quality tools and techniques: Six Sigma, Effective Root Cause Analysis, Effective Use and Analysis of Data, Industry Benchmarking, Lean Manufacturing, Industry Associations.
Follows, maintains, and improves established quality systems and procedures.
Reads, understands and adheres to appropriate company and department policies and procedures to ensure legal compliance, safe and productive workplace and quality products and customer service.
Must immediately report any and all unsafe conditions and/or work related injuries/illnesses to supervisor.
Performs other duties, as assigned, to maintain efficiency throughout the company.
10-15% travel expected
Let's talk about Qualifications and Experience:
Bachelor's Degree in computer science, mathematics, statistics, business, or a quantitative analysis related field. Will accept equivalent experience, in lieu of a degree.
Minimum 5 years of experience in Supplier Quality Engineering
Must have a good understanding of the industry-specific issues, regulatory requirements, and current healthcare reform
Experience in Statistics and Quality Measures
Demonstrated quantitative analytical and strong critical thinking skills
Strong project management skills
Must have the ability to work in a fast-paced and creative environment
Proficient oral and written communication skills
Knowledge of Quality Management Systems, ISO 9001 and ISO 13485 requirements, Six Sigma, GMP and Lean Manufacturing Principles
Knowledge of basic statistical techniques; must be able to understand statistics compiled by suppliers to support evidence of conformance
Working Knowledge of Statistical Process Controls
Ability to Read, Interpret and Understand Blue Prints
Knowledge and Understanding of Geometric Dimensioning and Tolerance
Data Collection and Recording Skills
Knowledge of motor and/or rotary components
Knowledge of electronic components
Mechanical Inspection Knowledge
Desirable:
PPAP (Production Part Approval Process) experience
Medical Device quality systems experience
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Joining us is more than saying "yes" to making the world a healthier place. It's discovering a career that's challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now!