- Will act as an expert resource in external regulations and standards requirement knowledge for cross functional teams. Is viewed as a leader in the areas of quality systems and ISO standards and Medical Device Regulations within one’s own group, constantly promotes awareness of best industry practices making appropriate decisions on a daily basis.
- Implementation of internal requirements and external laws, regulations, guidance’s and standards as applicable to company quality systems.
- Champions continuous improvement and innovation from a quality system perspective.
- Lead and support site External Inspections.
- Identify areas of potential noncompliance or improvements by managing and conducting internal audits to schedule
- Educate functional areas on quality system requirements.
- Participate cross functionally and across business units to standardize Quality System policies and procedures.
- Collect and analyze business/quality system process data from different parts of the company.
- Manages the site corrective and preventive actions and product containment process.
- May on occasion be required to travel in order to provide support the business or other sites in this area of responsibility.
- Is an effective team member and leader, fully motivated to achieve and demonstrate best practices in line with the department objectives.
Quality System Requirements:
In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
For those individuals that supervise others, the following statements are applicable:
- Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the Quality Policy.
- Establishes and promotes a work environment that supports the Quality Policy and Quality System.
Qualification & Experiences:
- Level 8 Quality qualifications and 3/5 years relevant work experience
For a confidential discussion and more information on the role, please contact Eloisa on 021 4809118 or email firstname.lastname@example.org