NPD Quality Engineer
Apply NowCompany: Trelleborg AB
Location: Delano, MN 55328
Description:
Trelleborg Healthcare and Medical is seeking a NPD Quality Engineer to join their team. Responsible to plan and coordinate quality assurance activities for medical device manufacturing through the design and development phases including validation for new product development. Collaborate with New Product Development (NPD) teams to support equipment qualification, software validation, test method development/validation, process development/validation (IQ/OQ/PQ), and other quality processes to ensure compliance with the company's Quality System and applicable external requirements and standards, including FDA, ISO 13485, and/or other regulatory agencies as applicable to medical device manufacturing. Working with internal and external customers to support creative approaches and solutions to problems.
As a valued Trelleborg team member, you will enjoy:
Qualifications:
Required:
Desired:
Quality Engineer Expectations:
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 1, Gage Repeatability and Reproducibility (GRR), 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
Competencies
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
Ability to demonstrate adequate job knowledge to deliver a world class performance
Ability to challenge oneself to consistently meet all goals and deadlines
Willingness to strive for excellence by producing work that is free of errors and mistakes
Desire to delight both customers and coworkers by offering encouragement, fostering teamwork and addressing conflict appropriately
Commitment to making improvements company wide
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
Good manual dexterity
Correctable normal reading distance vision
Travel: Up to 25% across sites
Salary info: $78-92k
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)
As a valued Trelleborg team member, you will enjoy:
- Greater opportunity for impact
- Competitive compensation
- Generous benefits package: Health, Dental, Vision, STD, LTD, Life, 401k
- Paid time off
- Bonus
Qualifications:
Required:
- 4-year degree in quality, engineering, or any related field
- 2+ years in a manufacturing environment in a technical support role
Desired:
- ASQ Certified Quality Engineer
- Formal Six Sigma Yellow/ Green belt training
- Knowledge and experience with GMP/ISO Standards: ISO 9000/9001, ISO 13485, and FDA 21CFR 820/11 (4/210/211 as applicable)
Quality Engineer Expectations:
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 1, Gage Repeatability and Reproducibility (GRR), 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
Competencies
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
Ability to demonstrate adequate job knowledge to deliver a world class performance
Ability to challenge oneself to consistently meet all goals and deadlines
Willingness to strive for excellence by producing work that is free of errors and mistakes
Desire to delight both customers and coworkers by offering encouragement, fostering teamwork and addressing conflict appropriately
Commitment to making improvements company wide
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
Good manual dexterity
Correctable normal reading distance vision
Travel: Up to 25% across sites
Salary info: $78-92k
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)