In this role, you will…
- Assist with implementing and maintaining a Global Operations QMS strategy
- Support Global QMS Policies implementation and maintenance, assessment of QMS processes within Global QMS policies, regulations and standards
- Responsible for the creation, maintenance and integrity of the SOPs, WIs, Forms and Templates for Global processes, including automated solutions when applicable
- Manage the CAPA and NC process at a Global level: collaborate with regional associates, hold monthly CAPA and NC board meetings, train associates, provide metrics and ensure that CAPA and NC meet QMS requirements
- Working with QMS leaders from different regions and business units to maintain effective QMS and conduct training as appropriate
- Support the business during internal and external audits
- Collaborate with cross-functional teams, to establish and document procedures and work instructions
- Collect, monitor, analyze and present data for key performance indicators (KPIs), management review, global meetings and additional forums
Typically:
- Bachelor’s degree in Science, Engineering, or with any relevant background
- Minimum of 3 years of relevant experience in QA at Medical Device company
- Knowledge of quality management principles specific to the medical device industry, including ISO 13485, FDA QSR, and EU MDR (an advantage)
- Experience working with non-conformances, corrective and preventive actions
- Knowledge of effective root cause investigation, corrective and preventive action planning and execution and verification of effectiveness techniques
- Strong written and verbal communication skills
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams
- Ability to lead end to end activities
- English – High level proficiency required (written and spoken)
- High level Computerized system skills
- Certified Quality Engineer (CQE / CQM) – an advantage
