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.
- Use critical thinking to determine the best approach.
- Use experience within Design Assurance or production and processing of medical devices to provide guidance and assistance in the development of new products.
- Participate and lead in Risk Management activities in accordance with ISO 14971:2019.
- The development, implementation, and approval of Hazard Analyses, FMEAs, and other Risk Analysis documentation.
- Use experience with engineering and technology to identify and ensure compliance with applicable standards and regulations.
- Lead investigations resulting in root cause and corrective actions 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.
- Ensure the accurate documentation and recording of information to be used in communication with partners and regulatory bodies.
- Prepare detailed work plans such as Master Validation Plans.
- Lead system and process improvements using six sigma tools.
- Provide reliability and statistical analysis.
- Conduct test method validations for formal testing.
- Participate in internal and external audits.
- Interface with partners on quality topics.
- Evaluate and approve proposed design or manufacturing process change.
- Drive system and process improvements.
- Manage Suppliers and Supplier Qualifications per applicable Millyard supplier quality procedures.
- Manage the Supplier Corrective and Preventive Action requests.
- Facilitate the review and approval of supplier-initiated changes and communicate the approved changes to the appropriate departments.
- Bachelor’s degree in an engineering or related STEM discipline. Additional training and experience may be considered in lieu of degree.
- Minimum 5 years' experience in any suitable occupation related to quality assurance of medical devices.
- Experience with medical devices and direct responsibility for Risk Analysis and Design Transfer required.
- Experience with compliance, applicable standards and regulations such as 21 CFR 820 and ISO 13485:2016 required.
- Experience developing and leading quality system procedures required.
- Experience supporting regulatory body submissions preferred.
- Experience participating in internal and external audits preferred.
- Hands-on experience in Supplier Qualification, Supplier Audits, and Supplier Corrective Action.
- Ability to:
- Multitask and carry tasks through to completion.
- Manage multiple sources of data and develop reports.
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 and 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.
Top Skills
What We Do
DEKA is one of the leading research and development companies in the country and is the birthplace of some of the most innovative and life-changing products of our time. For over thirty years, DEKA Research & Development Corp. has made Manchester, New Hampshire home. Located about an hour from Boston, the beach, and the mountains, we are situated in the beautiful and historic Amoskeag Millyard buildings located in downtown Manchester.
DEKA continues to be a place where no idea seems too big and where creativity and crazy cool gizmos reign supreme. The engineers, technicians, machinists, designers and all of the other folks who make up DEKA are some of the most creative and innovative professionals you could ever hope to meet. It's a place where one crazy idea can end up being the next greatest invention. At DEKA we embrace the spirit of innovation and constantly aim to turn the impossible into a reality.
DEKA is filled with people who are driven to be among the best and brightest in their field of work. It’s a concentrated bunch of really smart thinkers, doers and problems solvers, who are driven to using innovative design solutions and state-of-the-art technology to improve lives. We all see endless possibilities in the power of technology to do good. Employees have the opportunity to work on diverse projects that have a positive, enduring impact on millions of people worldwide. We are growing! We're always seeking passionate individuals to join our growing team of evolved thinkers.
