- Proactively investigates, identifies, and implements best-in-class Quality Engineering practices.
- Provide focused quality engineering support and assume responsibility for timely and effective coordination and/or execution of assigned development project activities.
- Establish effective corrective action plans. Lead in implementation of quality assurance plans, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
- Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
- Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Review and approve product and process qualification and validation and other change control related documentation.
- Develop product/process assurance plans, which include all required elements. Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements
- Generate internal quality documentation such as quality plans, standard operating procedures and inspection procedures.
- Participate in Product Review Boards. Identify non-conformance trends and develop technical investigation plans. Investigates and analyze customer/internal complaints.
- Performs analytical measurements and experiments to qualify or resolve product and process issues.
- Will be responsible for developing and implementing strategic quality plans, master validation plans, validation protocols, inspection plans and quality/regulatory compliance operating procedures to meet FDA (Food and Drug Administration) and ISO (International Organization of Standardization) requirements.
- Track quality trends and initiate action items to resolve issues. Manage assigned corrective actions.
- Monitor field quality and analyze field returns to determine root cause.
- Provide training and support for quality system processes and quality engineering practices.
- Requires a minimum of a 4 year degree in engineering, life sciences, or similar.
- Requires 8+ increasing responsibility and experience in a medical device quality assurance environment.
- Prefer one to two years of auditor experience.
- Communication skills both verbal and written.
- Organizational skills as well as time management skills essential for project work.
- Prefer certification as a CQA, CQE, or CQM, and member of the ASQ.
- Excellent computer skills
- Strong writing, mathematics and statistics skills
-
Quality Engineer
3 days ago
Apex Innovations Chester, United StatesAUMA - an innovative, medium-sized family business headquartered in Müllheim i. M. - has been developing, producing and distributing electric actuators and valve gearboxes for various industries such as water and energy for 60 years. With 2,800 employees worldwide, AUMA is one of ...
-
Quality Engineer II
3 weeks ago
Terumo Medical Corporation Elkton, United StatesFor more than 100 years, the name Terumo has been synonymous with innovative medical devices. From its start as a manufacturer of clinical thermometers, Terumo has grown worldwide to a position of leadership in such areas as hollow fiber technology, blood management systems, and ...
-
Sr. Quality Engineer
3 weeks ago
Terumo Medical Corporation Elkton, United StatesWhy Apply? · This role will afford you exposure to many different experiences. For example, Terumo is currently in the process of converting from a very manual and paper-based manufacturing process to MES (Manufacturing Execution System), we are beginning to automate many of our ...
-
Manufacturing Quality Engineer
2 weeks ago
Terumo Medical Corporation Elkton, United StatesJob Summary: · This position is responsible for investigating, planning, and implementing improvements in and/or additions to current products and manufacturing processes that directly affects safety, quality, and productivity with the end result of producing a better quality pro ...
-
Quality Engineer I
22 hours ago
Terumo Medical Corporation Elkton, United States**At this time we are only considering US Citizens and Greencard Holders** · We believe that the future is bright for everyone at Terumo. We work with the future in mind to generate lasting change, create a bigger impact and produce greater outcomes for today, and for decades to ...
-
Quality Engineer II
3 weeks ago
Terumo Medical Corporation Elkton, United StatesFor more than 100 years, the name Terumo has been synonymous with innovative medical devices. From its start as a manufacturer of clinical thermometers, Terumo has grown worldwide to a position of leadership in such areas as hollow fiber technology, blood management systems, and ...
-
Quality Engineer II
2 weeks ago
Terumo Elkton, United StatesTerumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-c ...
-
Quality Engineer II
3 weeks ago
Terumo Elkton, United StatesTerumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-c ...
-
Sr. Quality Engineer
2 weeks ago
Terumo Medical Corporation Elkton, United StatesWhy Apply? · This role will afford you exposure to many different experiences. For example, Terumo is currently in the process of converting from a very manual and paper-based manufacturing process to MES (Manufacturing Execution System), we are beginning to automate many of our ...
-
Quality Engineer II
1 week ago
Terumo Cardiovascular Group Elkton, United StatesPress Tab to Move to Skip to Content Link · Select how often (in days) to receive an alert: · Select how often (in days) to receive an alert: · Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devic ...
-
Senior Quality Engineer
1 hour ago
Experis Elkton, United StatesA leading global medical device company is looking for a Sr. Quality Engineer to start ASAP. Sr. Quality Engineer required to work in Elkton, MD (Hybrid schedule after training). This is a Direct-Hire opportunity (NO sponsorship) Interested individuals are encouraged to contact o ...
-
Sr Quality Engineer
5 days ago
Terumo Medical Corporation Elkton, United StatesSr Quality Engineer · Date: May 2, 2024 · Req ID: 2491 · Location: · Elkton, MD, US · Company: Terumo Medical Corporation · Department: QM Manufacturing Ops · Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-qualit ...
-
Quality Engineer II
2 weeks ago
Terumo Elkton, United StatesTerumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-c ...
-
Senior Quality Engineer
5 days ago
Manpower Group Inc. Elkton, United StatesA leading global medical device company is looking for a Sr. Quality Engineer to start ASAP. Sr. Quality Engineer required to work in Elkton, MD (Hybrid schedule after training). This is a Direct-Hire opportunity (NO sponsorship) Interested individuals are encouraged to contact o ...
-
Manufacturing Quality Engineer
3 weeks ago
Terumo Medical Corporation Elkton, United StatesJob Summary: · This position is responsible for investigating, planning, and implementing improvements in and/or additions to current products and manufacturing processes that directly affects safety, quality, and productivity with the end result of producing a better quality pr ...
-
Quality Engineer II
2 weeks ago
Terumo Medical Corporation Elkton, United StatesFor more than 100 years, the name Terumo has been synonymous with innovative medical devices. From its start as a manufacturer of clinical thermometers, Terumo has grown worldwide to a position of leadership in such areas as hollow fiber technology, blood management systems, and ...
-
Manager Quality Engineering
3 weeks ago
Terumo Medical Corporation Elkton, United StatesJob DescriptionJob Description · Job Summary: · The Manager, Quality Operations is responsible for managing quality operations functions within the respective manufacturing facility. S/he is responsible for ensuring compliance with the applicable regulations of all countries in ...
-
MES Quality Engineer II
1 week ago
Terumo Medical Corporation Elkton, United StatesJob Summary: · The Manufacturing Execution System (MES) Quality Engineer II position will work closely with the IT, Operations, Validation, and Engineering, teams to ensure that projects (new MES deployments, sustaining, and/or optimization) related to MES are implemented compli ...
-
MES Quality Engineer II
3 days ago
Terumo Medical Corporation Elkton, United StatesWe believe that the future is bright for everyone at Terumo. We work with the future in mind to generate lasting change, create a bigger impact and produce greater outcomes for today, and for decades to come. · At Terumo we believe in the power of personal growth and will encour ...
-
Manager, Quality Engineer PMS
1 week ago
Terumo Elkton, United StatesTerumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-c ...
Sr. Quality Engineer - Elkton, United States - Terumo Medical Corporation
Description
Why Apply?
This role will afford you exposure to many different experiences. For example, Terumo is currently in the process of converting from a very manual and paper-based manufacturing process to MES (Manufacturing Execution System), we are beginning to automate many of our processes and move away from a manual production environment, we are transitioning to a much more capable ERP system (from JD Edwards to SAP), and in about 12 months moving from a paper-based to electronic quality system. These projects are great experience builders and provide for a fast-paced and hands-on work environment. This Engineer is empowered to make real changes and improve existing processes, and also mentor more junior team members in the process. For scope, our factory is 300,000 square feet with about 900 employees, and both high volume and low volume manufacturing.
Job Summary: **Prior On-site Manufacturing Experience is Required for this Position**
This position is responsible for investigating, planning, and implementing improvements in and/or additions to current products and manufacturing processes that directly affects safety, quality, and productivity with the end result of producing a better quality product more efficiently. Ensure compliance to Terumos quality policy, respond to customer complaints, perform audits, develop test methods, and/or write procedures for material characterization.
Job Details:
Background Experiences
