Responsibilities
Provide Design Quality Engineering support throughout the product development
lifecycle ensure compliance with regulations and internal Quality Management
System procedures.
Provide support to new product development and sustaining engineering projects
including review and approval change orders.
Use technical expertise, knowledge, and experience to rapidly innovate the
companies' medical devices for use in chronic heart failure patients.
Facilitate and conduct risk management activities including development of Risk
Management Plans, Hazard Analyses, Design Failure Modes and Effects
Analysis () and Risk Management Reports.
Participate in reviewing design inputs and design output requirements, ensure
risk control measures and cybersecurity requirements are transformed into
product requirements.
Participate in V&V activities, review verification and validation plan, test protocol
reports.
Participate in product cybersecurity activities including product security planning,
threat analysis, cybersecurity risk assessments, periodic monitoring and
reporting.
Apply sound, systematic problem-solving methodologies in identifying,
prioritizing, communicating, and resolving quality issues as related to the position
responsibilities.
Contribute to the success of the Quality System performance measures by
completing tasks on time and with a high level of Quality
Provide support during Corrective and Preventive Action (CAPA) activities and
manage the CAPA system as necessary.
Support 3rd party audits, including follow-up on actions and quality department
initiatives.
Ensure compliance of QMS through authoring and updating Standard Operating
Procedures (SOP).