As our “Lead Quality Systems” you will give direction to the implementation and maintenance of quality systems of the whole organization and run internal and supplier audit programs for the business.
Auditing of suppliers includes contractors, sub-contractors, suppliers of service as well as suppliers of parts/ materials.
You will also manage the key quality system activities, including QS architecture, internal audit schedule, plan vendor management, and report to management the key quality metrics.
You will train internal auditors and build towards the creation of a cross-functional internal audit team. You are a key leader within the quality and regulatory team. This includes working on quality strategy, failure investigation, product performance analysis, validations.
When audits highlight opportunities for improvement, the audit team collaborates on the creation of corrective action plans with the auditee.
You will need to make sure that all relevant data collection, analysis and review activities are carried out to a high standard and can be both audited and defended.
All activities meet the requirements of ISO 13485 and 21 CFR 820, and the “Quality System Lead” is a champion of Design controls and data quality.
You will be reporting to our VP Quality and Regulatory Affairs.