Nonin Medical, Inc.
You can count on Nonin. Our vision is to improve people’s lives by creating noninvasive medical devices people can count on. Nonin’s culture is grounded in our mission, and we live by our cultural tenets of courage, ownership, and agility. The courage to challenge assumptions and take risks, the ownership to act with accountability, and the agility to constantly innovate and move with speed. It is these tenants that have made Nonin the technology leader for over 30 years. As a privately owned company, each of us operate with a shared commitment and act as family versus colleagues. You are not one among many, but an important part of our success with the ability to learn, grow and impact all aspects of the business. Recognizing that each one of us is unique, we build flexibility and choice into our philosophies. We embrace the unique backgrounds, perspectives, and mindsets of our employees and collaborate to build a more rewarding environment for all to work, thrive and have a little fun. So, if you are looking for a smaller company to spread your wings while making big company impacts, join Nonin today… Together we will improve lives around the world, including your own.
Location : Minneapolis, Minnesota
What you will do:
Responsible for Nonin Medical manufacturing product quality and regulatory compliance. Analyze statistical data and product specifications to determine standards and establish quality and reliability objectives of finished product, including regulatory compliance, GMP, and ISO 13485. Coordinate and implement quality control objectives, activities, or procedures to resolve production problems, maximize product reliability, or minimize costs. Implement process improvements that result in predictable process performance across all manufacturing product lines. Responsible for process variability and risk reduction, scrap reduction, and post market quality investigations. Ensure all process variables and their interactions are adequately defined in addition to verifying that all process failure modes have been identified and addressed. Evaluate precision and accuracy of production and testing equipment. Implement statistical techniques to monitor process performance (e.g. SPC, CpK analysis, sampling plans). Approve product and process change requests in compliance with business policies and procedures. Analyze customer complaints, conduct product failure analysis, determine root cause, and implement permanent corrective action issue resolution. Conduct risk analysis including Health Hazard Assessments as required. Define process and product validation requirements, prepare and approve Master Validation Plans, protocols and reports. Disposition product suspected as being non-conforming and review performance trends to determine the effectiveness of corrective action. Support regulatory agency and customer quality audits and CAR’s. Develop product quality plans, project protocols in documents, and systems by creating product specifications, quality specifications, and accurate quality plans in conjunction with other product development team members to deliver quality product to the customer. Conduct data analysis using Six Sigma tools to assist in the reduction of defects. Estimate production costs, cost saving methods, and the effects of product design changes on expenditures. Utilize the following tools and technologies: Lean, Six Sigma, Kaizen, CAPA Administration, and Minitab. Position requires domestic travel up to 10% as needed and customary for the occupation. Position Requirements:
The position requires a Master’s degree or foreign equivalent degree in Industrial Engineering, Industrial & Human Factors Engineering, or closely related field. The qualified candidate must have at least 2 years (24 months) of experience in a quality engineer position or closely related occupation. The qualified candidate must also have at least 2 years (24 months) of experience with all of the following: (a) analyzing statistical data and product specifications to determine standards and establish quality and reliability objectives of finished product, including regulatory compliance; (b) initiating, reviewing, and processing change requests in compliance with business policies and procedures; (c) evaluating and determining underlying product issues utilizing root cause analysis, and developing and implementing long-term and permanent corrective action plans to resolve issues; (d) conducting risk analysis and updating risk management processes; (e) designing and defining product development and validation requirements; and (f) utilizing the following tools, technologies and methodologies: Lean, Six Sigma, Kaizen, CAPA Administration, and Minitab. All experience may be gained concurrently. Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws.
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Responsible for Nonin Medical manufacturing product quality and regulatory compliance. Analyze statistical data and product specifications to determine standards and establish quality and reliability objectives of finished product, including regulatory compliance, GMP, and ISO 13485. Coordinate and implement quality control objectives, activities, or procedures to resolve production problems, maximize product reliability, or minimize costs. Implement process improvements that result in predictable process performance across all manufacturing product lines. Responsible for process variability and risk reduction, scrap reduction, and post market quality investigations. Ensure all process variables and their interactions are adequately defined in addition to verifying that all process failure modes have been identified and addressed. Evaluate precision and accuracy of production and testing equipment. Implement statistical techniques to monitor process performance (e.g. SPC, CpK analysis, sampling plans). Approve product and process change requests in compliance with business policies and procedures. Analyze customer complaints, conduct product failure analysis, determine root cause, and implement permanent corrective action issue resolution. Conduct risk analysis including Health Hazard Assessments as required. Define process and product validation requirements, prepare and approve Master Validation Plans, protocols and reports. Disposition product suspected as being non-conforming and review performance trends to determine the effectiveness of corrective action. Support regulatory agency and customer quality audits and CAR’s. Develop product quality plans, project protocols in documents, and systems by creating product specifications, quality specifications, and accurate quality plans in conjunction with other product development team members to deliver quality product to the customer. Conduct data analysis using Six Sigma tools to assist in the reduction of defects. Estimate production costs, cost saving methods, and the effects of product design changes on expenditures. Utilize the following tools and technologies: Lean, Six Sigma, Kaizen, CAPA Administration, and Minitab. Position requires domestic travel up to 10% as needed and customary for the occupation. Position Requirements:
The position requires a Master’s degree or foreign equivalent degree in Industrial Engineering, Industrial & Human Factors Engineering, or closely related field. The qualified candidate must have at least 2 years (24 months) of experience in a quality engineer position or closely related occupation. The qualified candidate must also have at least 2 years (24 months) of experience with all of the following: (a) analyzing statistical data and product specifications to determine standards and establish quality and reliability objectives of finished product, including regulatory compliance; (b) initiating, reviewing, and processing change requests in compliance with business policies and procedures; (c) evaluating and determining underlying product issues utilizing root cause analysis, and developing and implementing long-term and permanent corrective action plans to resolve issues; (d) conducting risk analysis and updating risk management processes; (e) designing and defining product development and validation requirements; and (f) utilizing the following tools, technologies and methodologies: Lean, Six Sigma, Kaizen, CAPA Administration, and Minitab. All experience may be gained concurrently. Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws.
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