Location: Maple Grove, MN
to meet or exceed internal and external requirements. Work on development of and coordinate execution and documentation of Design Validation and Verification activities. Test method validation for design verification and validation test methods. Coordinate Root Cause investigations, corrective action determinations, and verification of effectiveness (CAPA) using proven quality tools and methodologies.
Support product Post Market activities such as backssment of risk based on post market signals, field backssments, and post market surveillance plans and reports. Participate in project teams to review and develop clear and concise user requirements, product specifications, plans, usability
studies, and design verification and validation studies, risk management file and other relevant design control deliverables. Partner with R&D to determine and implement Design Controls based on Risk Management, Customer Needs, Supplier Needs, and Manufacturing Input.
May require to travel/telecommute. REQUIREMENTS: Employer requires a Masters degree in Mechanical Engineering, Manufacturing Engineering, or related technical field plus 24 months experience in job offered, Senior Quality Engineer 1, Design Quality Engineer, or related occupation. Experience must include: 1) Design Control, 2) Risk Management, 3) GD&T and Print Interpretation, 4) NCEP & CAPA, 5) key regulatory requirements,
(ISO 14791, 21 CFR 820, ISO 13485 and EU MDR), 6) Advanced Statistics, 7) Post Market Surveillance, 8) New product Development, 9) Verification & Validation, and 10) Root Cause Analysis.
WORKSITE: 1 Scimed Place, Maple Grove, MN 55311 CONTACT: Sarah Okusanya, Boston Scientific Corporation, Please include reference H4872-00895. (EOE).
Quality Assurance (QA) jobs involve the systematic monitoring and evaluation of the various aspects of a project, service, or facility to ensure that standards of quality are being met. The primary goal is to identify defects and issues before the product reaches the customer, thereby ensuring customer satisfaction and maintaining the reputation of an organization. QA roles often require attention to detail, strong problem-solving skills, and a good understanding of industry-specific regulations and standards. These jobs can vary widely, from software testing to food safety inspection, but they universally function as a critical checkpoint in the production and delivery process of goods or services.
Quality Assurance (QA) jobs involve ensuring that products, services, or processes meet established standards of quality through systematic activities and measures. These roles typically focus on preventing defects, identifying potential issues, and implementing solutions to maintain quality consistency. Key features of QA positions include rigorous testing, meticulous attention to detail, and a commitment to continuous improvement. QA professionals work across various industries, from software development to manufacturing, to safeguard customer satisfaction and comply with regulatory requirements.
Quality Assurance (QA) jobs entail roles focused on ensuring that products or services meet established standards and customer expectations. People in QA positions are responsible for designing testing processes, creating test plans, identifying defects, and preventing defects by examining the production process. They aim to enhance product reliability and actively work to maintain quality consistency. QA roles often require keen attention to detail, strong problem-solving skills, and an understanding of both product specifications and customer needs. QA is an integral part of product development and maintenance, bridging the gap between the manufacturing processes and the end users to ensure a satisfactory experience.
Quality Assurance (QA) jobs involve the systematic monitoring and evaluation of the various aspects of a project, service, or facility to ensure that standards of quality are being met. The primary goal is to identify defects and issues before the product reaches the customer, thereby ensuring customer satisfaction and maintaining the reputation of an organization. QA roles often require attention to detail, strong problem-solving skills, and a good understanding of industry-specific regulations and standards. These jobs can vary widely, from software testing to food safety inspection, but they universally function as a critical checkpoint in the production and delivery process of goods or services.
