This is a permanent role in our Belfast site with full Stryker benefits.
This position is responsible for the development, management and leadership of the Inspection team.
This will be the key point of contact for all quality functions and business areas that interact with the Inspection teams.
They will ensure compliance to applicable Global Regulations and standards (e.g. ISO, EN, and Medical Device Regulation (MDR) requirements).
Inspection Team
Manage team of Quality Inspectors
Lead QA Inspection team through training, development of team members job roles and responsibilities, and day to day management of the team
Provide direction and support to Quality Inspectors
Create a positive team environment with open communication and engaged team members
Communicate & keep team updated on all matters relevant to the business and cell in a timely and appropriate manner
Ensure that training happens according to the process instructions and occurs in a timely manner
Manage Core Time and Attendance System for Inspection team
Ensure that all employees are adequately trained, are aware of, and comply with EHS procedures
Ensure that employees are aware of and comply with all company policies and procedures
Ensure that good housekeeping is maintained in compliance with the 6S Program
Training
Support training programs (GMP/Line Clearance) across the site. Development of Inspector Accredited Certification program.
Support/ act as local subject expert for review, creation and training of divisional and corporate procedures.
Project Management
Project management in areas that focus on quality system improvements that systemically improve the level of quality and compliance within the Inspection department
Project management activities include: Project planning, personnel recruitment, containment and risk assessment activities and the compilation and communication of project metrics.
Productivity and Process Improvements
Develop, Manage and report on Inspection cell KPI’s
Continuously improve the performance of the Inspection cells.
Ownership and development of a risk-based approach for the inspection plans
Introduction of best practices in acceptance and inspection activities (Visual Standards/Measurement techniques Ops sheets).
Ensure that a consistent approach to inspection activities is developed and maintained.
Trending
Ensure issues & trends identified from Incoming Inspection are addressed, and effective root cause corrective actions put in place.
Develop, Manage and report on Quality Metrics.
Regulatory Compliance:
Ensure Regulatory compliance in area of responsibility to GMP of all medical device regulatory agencies (i.e. FDA, MoH, TUV, etc.).
Act as Incoming Inspection point of contact for internal and external audits (i.e. FDA, MoH, TUV, etc.). Ensure compliance to Divisional and Corporate procedures.
Qualifications
· Bachelor's Degree in Science, Engineering or related subject.
· 4+ year’s relevant QA experience in GMP manufacturing environment and experience managing a team
Travel Percentage: 10%