Quality Engineer II
The Quality Engineer II is responsible for conducting, and reporting on product, project and process activities related to medical device design and manufacturing as a team member. This position works with R&D and Manufacturing to develop and execute test protocols and reports. This position performs statistical analysis as required. The Quality Engineer II provides direction and works closely with R&D, Supplier Quality, Sustaining Engineering, and Manufacturing to ensure effective design transfer and successful on-going manufacturing.
Principle Responsibilities (essential job duties and responsibilities):
- Leads the development of process risk management per ISO14971 for assigned projects
- Participates in assigned project teams/tasks for the development and support of new and sustaining products and processes by providing quality engineering services to assigned projects with accountability for development, execution, and reporting of assigned activities for test method validation, design and process verification and validation, etc.
- Provides direction regarding statistical analyses; Ensures defendable engineering and scientific analyses are employed and design history files comply with company policies and governmental regulations.
- Approves protocols and reports; Acts as a quality reviewer for design reviews.
- Interacts frequently with other Quality departments, Manufacturing Engineering, Manufacturing, Global Supply Chain, Global Product Labeling, R&D, Regulatory Affairs, Service, and Marketing in order to support project and objective completion
- Facilitates the resolution of key quality issues by assisting in failure investigations (root cause analysis), assisting in problem resolution, and providing feedback to product development and manufacturing. Defines and establishes necessary quality initiatives.
- Acts as a resource for manufacturing sites with the interpretation of quality requirements including verification/validation planning and execution, first production run requirements, and problem resolution. Helps develop control plans that identify inspection characteristics, gauging techniques, and sampling requirements; Works with manufacturing sites to resolve conflicts and recommends revisions as required to ensure product quality.
- Facilitates audit functions to support audits by governmental competent authorities (e.g., US Food and Drug Administration (FDA) inspections), Notified Body audits, and internal/corporate audits; May participate in audits as a Technical subject matter expert.
- Reviews and approves updates to quality system documents, quality system documentation, and labeling for new and existing products.
- Reviews drawings to evaluate quality requirements including correct application of geometric dimensioning and tolerancing, proper use of engineering, process and material specifications, and identification of key characteristics for inspection plans and methods.
- Understands and applies the manufacturing quality toolset including sampling plans, control plans, process capability, SPC, DOE, process data analysis to ensure that quality is designed into products and processes.
- Participates in any and all reasonable work activities as may be deemed suitable and assigned by management.
- Conforms to, supports, and enforces all Company policies and procedures.
- Bachelor’s of Science in Mechanical Engineering, Biomedical Engineering, Industrial Engineering, Manufacturing Engineering, or similar engineering degree
- Minimum of 3 years experience in quality engineering with a Bachelor’s degree
- Experience in a regulated environment, such as medical devices, pharma, Food and Drug Administration cGMPs (i.e., 21 CFR Part 820), and/or Medical Device Directive
- Experience in the application of production and process controls including process validation, process control plans and statistical process control
- Experience using statistical software (e.g., Minitab, Jump)
- Experience in establishing statistical sampling requirements related to component/process criticality and risk
- Experience in creating, reviewing, and approving quality systems documentation
- Experience in development and use of device master record, device history record, and design history files
- Experience in leading Corrective and Preventive Action activities
- Experience interpreting and using ISO 13485
- Proficiency in Microsoft Office products (Word, Excel, Access, PowerPoint, and Project)
- Knowledge of International Organization for Standardization (ISO) standards
- Excellent written and oral communication skills
- Demonstrated knowledge of engineering/quality statistics and their application
- Demonstrated ability in project management
- Demonstrated ability to condense complex requirements into specific and measureable objectives
- Understanding of and ability to work with and update risk documents per ISO 14971
- Recognized as an expert in one or more technical areas
- Ability to manage personal and project activities in accordance with budgets and timelines with minimal supervision and guidance
- Ability to apply and interpret geometric dimensioning and tolerancing
- Ability to work effectively within a team environment
- Ability to deal effectively with all employees and external business contacts while conveying a positive, service-oriented attitude
- Master’s of Science in Mechanical Engineering, Biomedical Engineering, Industrial Engineering, Manufacturing Engineering, or similar engineering degree
- A quality engineering certification from the American Society for Quality, or other qualifying organization (e.g., CQE, CRE, and CQA)
- Medical device manufacturing experience
- Knowledge of electro-mechanical products
- Knowledge of lean manufacturing and Six Sigma
- Knowledge of metrology and inspection techniques
- Six Sigma Green Belt
- Knowledge of medical device process in one or more of the following areas: sterilization validation, biocompatibility, packaging validation, shelf life studies, software validation, injection molding
- Experience with Notified Bodies
The information listed above is not a comprehensive list of all duties/responsibilities performed.
This job description is not an employment agreement or contract. Management has the exclusive right to alter this job description at any time without notice.The information listed above is not a comprehensive list of all duties/responsibilities performed. This job description is not an employment agreement or contract. Management has the exclusive right to alter this job description at any time without notice. Any physical and mental requirements described in this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. EOE AA M/F/Vet/Disability: Acelity L.P. Inc. and its subsidiaries are an equal opportunity and affirmative action employer and give consideration for employment to qualified applicants without regard to race, ethnicity, color, religion, sex, sexual orientation, gender identity, pregnancy, national origin, age, disability, veteran status, or genetic information or any other legally protected characteristic. If you'd like more information about your EEO rights as an applicant under the law, please click here: http://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf VEVRAA Federal Contractor