Senior Quality Engineer
1 month ago
Job Description
Job Description Description:
Basic Function
The senior quality engineer position implements, maintains and enforces the internal quality management system to meet ISO standards and FDA quality system regulations.
This position works closely with development and manufacturing to establish/ensure compliance with the quality system throughout the development cycle. This position develops and implements
inspection/validation
processes necessary to verify products meet requirements as well as interact closely with Regulatory Affairs personnel (internal or external) to monitor product conformance.
Responsibilities
· Ensure company's adherence to the established Quality System and GMP/ISO standards, including ongoing establishment and improvement to the quality system procedures.
· Work with Engineering, Marketing, Manufacturing and Regulatory to establish measurable, valid product requirements.
· Develop and document product, process, and equipment test plan protocols, test procedures, and test reports.
· Perform tests according to various protocol requirements.
· Lead risk management and risk analysis activities.
· Devise design verification and validation plans for products based on performance specifications and risk analysis.
· Manage transition and communicate conformance to specifications, regulations and applicable international standards.
· Aide in definition and completion of in vitro and in vivo testing including applicable animal studies.
· Lead in defining and measuring process capability, process controls, and process validation.
· Define supplier quality specifications, sampling plans, and vendor qualification per quality system.
· Assist in specifications and testing of sterilization methods.
· Mentor other engineers on good engineering and testing practices
Requirements:
Qualifications
· Bachelor of Science in an engineering discipline or technical field required; advanced degree preferred.
· 5+ years of experience in the medical device industry; capital equipment and/or disposable device experience desired.
· Knowledge of FDA, GMP, and ISO 13485; past experience with QSR implementation is desired.
· Advanced computer skills, including statistical/data analysis and protocol/report writing.
· Demonstrated ability to effectively and clearly communicate concepts, ideas and knowledge to other individuals and teams.
· Strong analytical and problem solving skills, as well as a good background in the medical device development process.
· Comfortable working with and seeking optimum solutions with team members in adjacent disciplines of engineering.
· Previous start-up experience, a plus.
#J-18808-Ljbffr
-
Senior Quality Engineer
1 week ago
Burnsville, United States Robert Bosch Tool Corporation Full timeThe Senior Quality Engineer (SQE) will lead the quality function in product development to ensure quality targets are properly defined and implemented, lessons learned are translated (designed-in quality), while contributing Time-to-Market and high Quality Engineer, Engineer, Quality, Product Development, Senior, Project Management, Manufacturing, Technology
-
Senior Quality Engineer
1 month ago
Burnsville, United States Imricor Medical Systems Inc Full timeJob DescriptionJob DescriptionDescription:Basic Function The senior quality engineer position implements, maintains and enforces the internal quality management system to meet ISO standards and FDA quality system regulations. This position works closely with development and manufacturing to establish/ensure compliance with the quality system throughout the...
-
Senior Quality Engineer
2 days ago
Burnsville, United States Imricor Medical Systems Inc Full timeJob DescriptionJob DescriptionDescription:Basic Function The senior quality engineer position implements, maintains and enforces the internal quality management system to meet ISO standards and FDA quality system regulations. This position works closely with development and manufacturing to establish/ensure compliance with the quality system throughout the...
-
Senior Quality Systems Specialist
2 weeks ago
Burnsville, United States Imricor Medical Systems Inc Full timeJob DescriptionJob DescriptionDescription:Basic Function The Senior Quality Systems Specialist position is responsible for the support and ownership of a compliant and effective quality management system.Primary quality system functions include Corrective Action and Preventive Action (CAPA), Nonconformance Management, Internal and External Audit, Document...
-
Senior Quality Systems Specialist
2 days ago
Burnsville, United States Imricor Medical Systems Inc Full timeJob DescriptionJob DescriptionDescription:Basic Function The Senior Quality Systems Specialist position is responsible for the support and ownership of a compliant and effective quality management system.Primary quality system functions include Corrective Action and Preventive Action (CAPA), Nonconformance Management, Internal and External Audit, Document...
-
Senior Mechanical Engineer Plastics
1 week ago
Burnsville, United States Manpower Group Inc. Full timeManpowerGroup Senior Mechanical Engineer Plastics Burnsville , Minnesota Apply Now Our client is seeking a Senior Design Engineer with the ability to lead their own projects from cradle to grave. The scope of the role includes both new product and sustaining engineering efforts as well as support for our sales & marketing teams. Candidates must have a...
-
Senior Electrical Engineer
1 week ago
Burnsville, United States Imricor Medical Systems Inc Full timeJob DescriptionJob DescriptionDescription:Basic Function The Senior Electrical Engineer operates and leads research and development at the team level. This role is responsible for the research, design, and development of capital systems products to ensure a successful product launch. This position will be focused on the electrical design of systems that meet...
-
Senior Electrical Engineer
2 days ago
Burnsville, United States Imricor Medical Systems Inc Full timeJob DescriptionJob DescriptionDescription:Basic Function The Senior Electrical Engineer operates and leads research and development at the team level. This role is responsible for the research, design, and development of capital systems products to ensure a successful product launch. This position will be focused on the electrical design of systems that meet...
-
Senior Project Engineer- Traffic
3 days ago
Burnsville, United States WSB and Associates Full timeForge ahead with WSB. WSB was founded on the understanding that culture drives results and we’ve dedicated ourselves to the value of strong relationships, collaboration and forward-thinking ideas. We’ve inspired each other to discover thoughtful and creative solutions that look beyond the needs of today to the opportunities of tomorrow. We invite you to...
-
Senior Project Engineer- Traffic
2 days ago
Burnsville, United States WSB and Associates Full timeForge ahead with WSB. WSB was founded on the understanding that culture drives results and we’ve dedicated ourselves to the value of strong relationships, collaboration and forward-thinking ideas. We’ve inspired each other to discover thoughtful and creative solutions that look beyond the needs of today to the opportunities of tomorrow. We invite you to...
-
Senior Electrical Engineer
1 month ago
Burnsville, United States POWER Engineers Full timeFacilities Senior Electrical EngineerPOWER Engineers, Inc. is seeking a Senior Electrical Engineer for our Facilities Electrical Group. In this role, you will work with a multi-disciplinary engineering team leading and executing the electrical power components of industrial and government projects. The position involves creating and issuing construction...
-
Quality Engineer
6 days ago
Burnsville, United States Apothecary Products Full timeQuality Engineer Job Locations US-MN-Burnsville Category Quality/Regulatory FLSA Status Exempt Type Regular Full-Time The Career - What it is: Apothecary Products, LLC (APL) is currently adding a Quality Engineer to its team. In partnership with Quality leadership, you will help ensure our...
-
Quality Engineer
1 week ago
Burnsville, United States Apothecary Products Full timeQuality Engineer Job Locations US-MN-Burnsville Category Quality/Regulatory FLSA Status Exempt Type Regular Full-Time The Career - What it is: Apothecary Products, LLC (APL) is currently adding a Quality Engineer to its team. In partnership with Quality leadership, you will help ensure our product portfolio of self-care wellness...
-
Quality Engineer
2 days ago
Burnsville, United States Apothecary Products Full timeQuality Engineer Job Locations US-MN-Burnsville Category Quality/Regulatory FLSA Status Exempt Type Regular Full-Time The Career - What it is: Apothecary Products, LLC (APL) is currently adding a Quality Engineer to its team. In partnership with Quality leadership, you will help ensure our...
-
Quality Engineer
2 days ago
Burnsville, United States Apothecary Products Full timeQuality Engineer Job Locations US-MN-Burnsville Category Quality/Regulatory FLSA Status Exempt Type Regular Full-Time The Career - What it is: Apothecary Products, LLC (APL) is currently adding a Quality Engineer to its team. In partnership with Quality leadership, you will help ensure our product portfolio of self-care wellness...
-
Senior Substation Design Engineer
16 hours ago
Burnsville, United States POWER Engineers Full timeSenior Substation Design Engineer Job Summary POWER Engineers is currently seeking a senior level Electrical Engineer with substantial experience in substation design (or equivalent) to work in the Power Delivery Substation Department of our Minneapolis office located in Burnsville, MN. This is an in-office position but flexibility is available for a hybrid...
-
Quality Engineer
2 weeks ago
Burnsville, Minnesota, United States Apothecary Products Full timeQuality EngineerJob LocationsUS-MN-BurnsvilleCategoryQuality/RegulatoryFLSA StatusExemptTypeRegular Full-TimeThe Career - What it is:Apothecary Products, LLC (APL) is currently adding a Quality Engineer to its team. In partnership with Quality leadership, you will help ensure our product portfolio of self-care wellness solutions and pharmacy supplies...
-
Quality Engineer
2 days ago
Burnsville, Minnesota, United States Apothecary Products Full timeQuality EngineerJob LocationsUS-MN-BurnsvilleCategoryQuality/RegulatoryFLSA StatusExemptTypeRegular Full-TimeThe Career - What it is:Apothecary Products, LLC (APL) is currently adding a Quality Engineer to its team. In partnership with Quality leadership, you will help ensure our product portfolio of self-care wellness solutions and pharmacy supplies...
-
Senior Level Civil Engineer
1 month ago
Burnsville, United States POWER Engineers Full timeSenior Level Civil Engineer Passionate? Creative? Like to mix work and fun? Looking for a great company to build your career? At POWER Engineers, Inc., you can have a rewarding experience at every level. We are currently looking for a civil engineer who is hungry for challenging and meaningful work. In this role, you'll have the chance to make a positive...
-
Senior Electrical Engineer
5 hours ago
Burnsville, United States Leonardo DRS Full timeJob ID:109892 Leonardo DRS Naval Electronics has an unmatched track record in submarine and surface combat systems, tactical networks, communications, above water sensors, weapon systems electronics, radar, and command & control solutions. We are the largest and most successful naval complex electronics supplier delivering logistics and depot support for our...
