Senior Quality Engineer

DEKA R&D has an immediate opening for a Sr. Quality Engineer to work in the Quality Department in a dynamic Medical Device Research and Development environment.  The position reports to the Director of Quality.  We are seeking a Sr. Quality Engineer to provide Quality guidance in a dynamic, fast-paced medical device research, design assurance, 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.
• 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.

To be successful in this role, you will need the following skills & experience:

• 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.

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 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.

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