Trelleborg Medical Solutions
Senior NPD Quality Engineer
Trelleborg Medical Solutions, Delano, Minnesota, United States, 55328
Overview
Trelleborg Medical Solutions provides pay range information and is seeking a Senior NPD Quality Engineer to plan, develop, and execute quality assurance activities throughout the product development lifecycle for medical device manufacturing, including validation for new product development. The role involves collaborating with New Product Development (NPD) teams to support equipment qualification, software validation, test method development/validation, and process development/validation (IQ/OQ/PQ) to ensure compliance with the Quality System and applicable regulatory standards (FDA, ISO 13485, and others as applicable). Base pay range
$90,000.00/yr - $115,000.00/yr Direct message the job poster from Trelleborg Medical Solutions Responsibilities
In conjunction with the NPD team, plan, develop and execute equipment, software, test method, and/or process validation strategy. Perform risk management by identifying, estimating, evaluating, controlling, and monitoring risk, utilizing risk tools such as Process Failure Modes and Effects Analysis (pFMEA). Author or approve protocols and reports for Equipment Qualification (IQ/EQ), Software validation (SV), Test Method Validation (TMV), Process validation (OQ/PQ). Review and evaluate specifications, drawings, quality agreements, customer documentation and other documents as necessary to support NPD projects. Plan, coordinate, and oversee Test Method Development and Validation activities, initiate inspection plans for new/revised product. Develop test methods or work with the Metrology team to recommend equipment, sampling plans, and measurement techniques for inspection specifications. Perform measurement system analysis (MSA) Gage R&R, Bias and Linearity, Resolution and Stability studies. Perform statistical analysis of inspection data, process characterization, design of experiments (DOE) results, ANOVA, Capability Analysis. Author and execute Quality Plans for Quality Management Systems and Organizational Objectives projects. Initiate and perform root cause analysis, using statistical and capability analysis to solve problems. Adhere to the company’s Quality System (QS), write, and approve QS documents. Review and ensure compliance with QMS of all validation documents and records. Support Engineering, Manufacturing, and Inspection personnel in design, methods, tooling, validations, and other areas related to the control of product. Communicate with customers on clarification of specifications, completing customer documents, complaints, process changes, and other projects as needed. Understand regulatory requirements (e.g. ISO13485, 9001, 14971, FDA 21 CFR 820, ITAR). Provide periodic work direction and assistance to QA inspectors, QA technicians and Quality Engineering Technicians. Support other quality activities as necessary such as customer complaint (CC) and RMA system per procedures, corrective and preventive actions (CAPA). Support internal and external audits. Qualifications
4 year degree in quality, engineering or any related field. 5+ years in a manufacturing environment in a technical support role. Knowledge and experience with GMP/ISO Standards. Required Skills
Ability to read, write, speak and understand the English language (with a translator, if necessary). Ability to communicate clearly by conveying and receiving ideas, information and direction effectively. Desire to delight both customers and coworkers by offering encouragement, fostering teamwork and addressing conflict appropriately. Demonstrated competence using Microsoft Office, Project, Access and JMP. Comprehensive understanding of applicable Work Instructions, SOPs, and ISO standards. Working knowledge of statistical methods associated with six sigma and quality control. Able to perform math functions. Effective project leader. Experience with lean manufacturing principles and their implementation. Good hand/eye coordination and depth perception. Correctable normal reading distance vision. Preferred Skills
ASQ Certified Quality Engineer and/or Auditor. Class I, II, and/or III Medical device manufacturing experience. Pay range and compensation package
Salary range: $90,000-115,000/year Benefits
Competitive compensation with bonus opportunities. Generous benefits package: health, dental, vision, STD, LTD, life, 401k, paid time off, tuition reimbursement, and more. Clean, climate-controlled work environment. Opportunity to impact the production of life-saving devices. Growth and advancement opportunities within a global company. Equal Opportunity Statement
Trelleborg is committed to diversity and inclusivity in the workplace.
#J-18808-Ljbffr
Trelleborg Medical Solutions provides pay range information and is seeking a Senior NPD Quality Engineer to plan, develop, and execute quality assurance activities throughout the product development lifecycle for medical device manufacturing, including validation for new product development. The role involves collaborating with New Product Development (NPD) teams to support equipment qualification, software validation, test method development/validation, and process development/validation (IQ/OQ/PQ) to ensure compliance with the Quality System and applicable regulatory standards (FDA, ISO 13485, and others as applicable). Base pay range
$90,000.00/yr - $115,000.00/yr Direct message the job poster from Trelleborg Medical Solutions Responsibilities
In conjunction with the NPD team, plan, develop and execute equipment, software, test method, and/or process validation strategy. Perform risk management by identifying, estimating, evaluating, controlling, and monitoring risk, utilizing risk tools such as Process Failure Modes and Effects Analysis (pFMEA). Author or approve protocols and reports for Equipment Qualification (IQ/EQ), Software validation (SV), Test Method Validation (TMV), Process validation (OQ/PQ). Review and evaluate specifications, drawings, quality agreements, customer documentation and other documents as necessary to support NPD projects. Plan, coordinate, and oversee Test Method Development and Validation activities, initiate inspection plans for new/revised product. Develop test methods or work with the Metrology team to recommend equipment, sampling plans, and measurement techniques for inspection specifications. Perform measurement system analysis (MSA) Gage R&R, Bias and Linearity, Resolution and Stability studies. Perform statistical analysis of inspection data, process characterization, design of experiments (DOE) results, ANOVA, Capability Analysis. Author and execute Quality Plans for Quality Management Systems and Organizational Objectives projects. Initiate and perform root cause analysis, using statistical and capability analysis to solve problems. Adhere to the company’s Quality System (QS), write, and approve QS documents. Review and ensure compliance with QMS of all validation documents and records. Support Engineering, Manufacturing, and Inspection personnel in design, methods, tooling, validations, and other areas related to the control of product. Communicate with customers on clarification of specifications, completing customer documents, complaints, process changes, and other projects as needed. Understand regulatory requirements (e.g. ISO13485, 9001, 14971, FDA 21 CFR 820, ITAR). Provide periodic work direction and assistance to QA inspectors, QA technicians and Quality Engineering Technicians. Support other quality activities as necessary such as customer complaint (CC) and RMA system per procedures, corrective and preventive actions (CAPA). Support internal and external audits. Qualifications
4 year degree in quality, engineering or any related field. 5+ years in a manufacturing environment in a technical support role. Knowledge and experience with GMP/ISO Standards. Required Skills
Ability to read, write, speak and understand the English language (with a translator, if necessary). Ability to communicate clearly by conveying and receiving ideas, information and direction effectively. Desire to delight both customers and coworkers by offering encouragement, fostering teamwork and addressing conflict appropriately. Demonstrated competence using Microsoft Office, Project, Access and JMP. Comprehensive understanding of applicable Work Instructions, SOPs, and ISO standards. Working knowledge of statistical methods associated with six sigma and quality control. Able to perform math functions. Effective project leader. Experience with lean manufacturing principles and their implementation. Good hand/eye coordination and depth perception. Correctable normal reading distance vision. Preferred Skills
ASQ Certified Quality Engineer and/or Auditor. Class I, II, and/or III Medical device manufacturing experience. Pay range and compensation package
Salary range: $90,000-115,000/year Benefits
Competitive compensation with bonus opportunities. Generous benefits package: health, dental, vision, STD, LTD, life, 401k, paid time off, tuition reimbursement, and more. Clean, climate-controlled work environment. Opportunity to impact the production of life-saving devices. Growth and advancement opportunities within a global company. Equal Opportunity Statement
Trelleborg is committed to diversity and inclusivity in the workplace.
#J-18808-Ljbffr