The purpose of the Senior Quality Engineer, HHE / Field Action is to assist with the planning, coordination, and execution of all aspects of Health Hazard Evaluations (HHE) and Field Actions (including corrections, removals, and market withdrawals) on behalf of the business to ensure compliance with our regulations.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Partner with site quality teams and manufacturing teams to complete robust and thorough Health Hazard Evaluations within established timelines.
Support all activities related to Health Hazard Execution preparation and closure.
Execute activities related to the field action process to ensure compliance with internal and external requirements.
Lead the data collection, analysis, and reporting of associated business metrics for the product HHEs and field action processes to various management reviews, business partners, and company scorecards.
Support FDA / BSI / TUV / MDSAP and other regulatory authority inspections / questions by providing information related to the HHE or field action process.
Partner with Medical Affairs, Customer Service, Product Quality, Legal Manufacturer, Regulatory Affairs, Supply Chain, and various international affiliate partners to execute worldwide field actions.
Participate or lead project-based improvement activities related to HHEs and field action processes.
Lead or attend and support the HHE and field action board meetings.
Support other QMS processes (e.g., CAPA, Non-Conformance, etc.).
Ensure field action timelines, as defined by the country regulations are met.
Ensure internal effectiveness checks of field actions are completed per timelines and documented per procedures.
Other duties may be assigned
QUALIFICATIONS, EDUCATION and / or EXPERIENCE :
Bachelor of Science Degree in Mechanical, Manufacturing or Industrial Engineering or equivalent preferred.
5-8 years of quality experience.
Technical writing experience required such as CAPAs, Nonconformances, etc.
Experience in the medical device or pharmaceutical industry is required.
Compliance experience preferred.
Experience with risk management, product risk assessments, and field action preferred.
Candidate must be able to communicate effectively at all levels within Quality as well as cross-functionally with departments such as R&D, Operations, Medical Affairs, Compliance, Manufacturing, etc.
Leadership ability to guide and influence others through Field Action and HHE processes
Understanding of other quality system processes (CAPA, complaints, NC, Mgt Review, etc.)
Willingness to have flexible work hours to support International stakeholders and / or business deadlines
Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.