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
• 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.

• 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.
• 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.

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