Manufacturing Quality Engineer II
Company: Terumo Medical Corporation
Posted on: June 24, 2022
Job 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 product more efficiently. Ensure compliance to
Terumo's quality policy, respond to customer complaints, perform
audits, develop test methods, and/or write procedures for material
characterization. - -Job Details:
- -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
- 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
- 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
- Generate internal quality documentation such as quality plans,
standard operating procedures and inspection procedures. Ensure QA,
FDA and ISO compliance in all areas of responsibilities.
- Participate in Product Review Boards. Identify non-conformance
trends and develop technical investigation plans. Investigates and
analyze customer/internal complaints.
- Must comply with requirements of applicable national and
- 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
- Provide training and support for quality system processes and
quality engineering practices.
- Perform other job related duties. -
- Knowledge, Skills & Abilities
- Knowledge of national and international regulations applicable
to medical devices including; Quality System Regulations, 21 CFR
820, 21CFR 803 and 804 (MDR regulations), Canadian Medical Device
Regulations, ISO 14971, ISO 13485, and MDD 93/42/EEC
- Prefer one year 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
- Excellent computer skills
- Strong writing, mathematics and statistics skillsBackground
- Requires a minimum of a 4 year degree in engineering, life
sciences, or similar.
- Requires three to six years experience in a medical device
quality assurance environment.
Keywords: Terumo Medical Corporation, Wilmington , Manufacturing Quality Engineer II, Engineering , Elkton, Delaware
Didn't find what you're looking for? Search again!