Senior Quality Engineer - medical device

Job Description

Job Description

InnoTECH Staffing has an immediate opening for a Sr. Quality Engineer to work in the Quality Department in a dynamic Medical Device Research and Development environment located in Manchester, NH.

This requires being onsite 5 days a week and must be a US Citizen or Greencard holder.

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 as a Senior Quality Engineer:

• 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.