DEKA R&D has an immediate opening for a Quality Engineer to work in the Quality Department in a dynamic Medical Device Research and Development environment.
The position reports to the Quality Manager. We are seeking a Quality Engineer to provide Quality guidance in a dynamic, fast-paced medical device research, development, and manufacturing and distribution environment.
How you will make an impact : Work cooperatively with cross functional design team members and project management to determine the best approach for on-going compliance with applicable SOPs and regulations, such as 21 CFR 820 and ISO 13485 Participate in and lead Risk Management activities in accordance with ISO 14971 The development, implementation, and approval of Hazard Analyses, FMEAs, and other Risk Analysis documentation.
Lead investigations including root cause identification, corrective actions, and verification of effectiveness, through use of data analysis, inductive and deductive reasoning, and problem solving skills.
Coordinate the efforts of individuals and teams performing investigations. Use experience within manufacturing and monitoring of medical devices, to provide guidance in Root Cause Analysis and CAPA.
Use experience with engineering and technology to identify and ensure compliance with applicable standards and regulations.
Ensure the accurate documentation / recording of information to be used in communication with partners and regulatory bodies.
Prepare detailed work plans and procedures such as Validation Plans. Evaluate and approve proposed design or manufacturing process change.
Drive system and process improvements. Provide reliability and statistical analysis. Participate in internal and external audits.
How you will be successful in this role : Bachelor’s degree in an engineering or related STEM discipline. Additional training and experience may be considered in lieu of degree.
Minimum 2-5 yrs. of experience as QE in a regulated manufacturing environment. Must be detail oriented and have strong communication both written and verbal.
Experience with compliance, with applicable standards and regulations such as 21 CFR 820, ISO 13485, and ISO 14971 is preferred.
Ability to : Multitask and carry tasks through to completion Manage multiple sources of data and develop reports About DEKA : One hour from the beach, Boston, and the mountains, the historic Amoskeag Millyard once housed the largest textile mills in the world.
It is now home to DEKA Research & Development, where we are taking the same innovation and cutting-edge technology into the modern age.
Behind DEKA’s brick walls sits a team of professionals who strive to make a difference every day through thoughtful engineering, design, and manufacturing.
Here at DEKA, some of the most innovative and life-changing products of our time are created, and new ideas are always welcome and explored. Powered by JazzHR
Quality Engineer
Responsible for planning, coordinating, and implementing broadly defined quality engineering practices for existing or new business activities. Complete ownership of quality processes that directly impact manufacturing outputs and internal requirements. Identify and communicate customer, regulatory ...
Senior Software Quality Assurance Engineer
As the Senior Software Quality Assurance Engineer, you will play a crucial role in steering Atmospheric G2’s strategic efforts to uphold the highest standards of product quality and reliability across all our product lines. Quality Assurance Engineer to join our team. We understand that the foundati...
Senior Quality Assurance Engineer
A dedicated Senior Quality Assurance (QA) Engineer adept at leading cross-functional QA activities, this role focuses on understanding business requirements at a functional level, identifying, writing, and testing detailed requirements with test cases. QA engineering roles, with a focus on software ...
Sr. Supplier Quality Engineer - REF2087A
Senior Supplier Quality Engineer. Site Operations to include, Manufacturing, Quality, Engineering, Program Management. ESA’s strategic plan through monitoring, managing and resolving issues related to Supplier quality performance. Conduct Source Inspections, Incoming Receiving Inspections, and Mater...
Quality Engineer
Job Title: Manufacturing Quality Engineer. Great matching candidates will have several years of quality engineering experience within the aerospace industry; focused on MRB and non-conformances. Quality Engineer Qualifications:. Interface with both local manufacturing technical teams and global desi...
Jr. NPI Quality Engineer
NPI Quality Engineer to support design transfer activities and quality operations in an innovative, fast-paced, medical device-manufacturing environment. How you will make an impact: Leverage your engineering and technical experience to evaluate new products, manufacturing processes and ensure compl...
Quality Engineer - Semiconductor - Manchester, NH
Manage supplier quality by establishing quality requirements, conducting audits, and addressing quality issues in the supply chain. Proven experience in quality engineering roles within the electronics industry or a related field, showcasing expertise in quality management systems and methodologies....
Continuous Improvement Quality Engineer II
Apply Quality Engineering techniques to new and existing products and processes. Represent technical quality in internal/external Quality System audits, inspections. BS in Engineering, Engineering Technology, or related field. Nordson MEDICAL designs, engineers and manufactures complex devices and c...
Quality Engineer
DEKA R&D has an immediate opening for a Quality Engineer to work in the Quality Department in a dynamic Medical Device Research and Development environment. We are seeking a Quality Engineer to provide Quality guidance in a dynamic, fast-paced medical device research, development, and manufactur...
Quality Assurance Engineer
We are seeking a Quality Assurance Analyst to join our team. As a QA Engineer at SmartCOP, you will be placed into a small development team for our Records Management System software used by law enforcement and conservation enforcement agencies nationwide. Bachelor’s degree in Computer Science or En...