Senior Quality Manager
DePuy Synthes are now recruiting for a Senior Quality Manager to join the Quality team – this opportunity will report directly into the Director of Quality Operations for DePuy Synthes.
Based at the DePuy Cork, Ireland site and reporting to the Regional Director of Quality Operations, the Senior Operations Quality Manager will lead from a Quality Manufacturing support perspective. They will also be a member of the site platform leadership team
The job holder will manage the validation process / technological / regulatory improvements in conjunction with Local & Global DePuy Quality, Engineering, Operations and R&D personnel ensuring timely communication to all stake holders to provide for a compliant and efficient validation lifecycle, including Metrology and Calibration.
The job holder will also manage the manufacturing process and supporting compliance activities in conjunction with local Quality, Operations and DePuy R&D personnel ensuring timely communication to all stake holders to effect successful project completion.
- All DePuy World Wide facility Quality, Operational and R&D management.
- DePuy Vendor management personnel.
- National Health regulatory bodies including FDA, notified bodies and other external auditors.
MAIN DUTIES & RESPONSIBILITIES:
- Manage the activities of a defined team of QC personnel. Management responsibilities to include day to day work allocation and prioritisation, performance and output quality review, coaching, training, internal communications and general personnel assistance during the course of their duties
- Responsible for recruitment, development and training of QC personnel.
- Work closely with other areas of Quality and the business to promote compliance
- Assist and where appropriate lead in the compilation and execution of validation protocols for new product/processes and software. Ensure correct implementation as per standard validation procedures. Re-validate as required due to engineering change, deviation analysis or upgrade in systems and material. Manage QA related change control for specific projects as directed.
- Lead Master Validation Planning activities
- Develop and utilise DFMEA/PFMEA and other QC risk analysis techniques in order to minimise potential risk during development/implementation activity.
- Be responsible for the introduction and correct use of statistical QC methods into the production environment, and provide technical resource for production team on relevant IQ/OQ/PQ protocol issues.
- Ensure compliance with all Documented Quality system, FDA QSR's and ISO 13485/9001 requirements during day to day and assigned audit/CAPA activities
- Monitor and establish reject and rework rates as directed. Report on these issues, and identify trends and appropriate corrective actions.
- Administration/implementation of Traceability for COC documentation, DHR systems
- Implement and maintain SOPs to ensure total compliance in areas of responsibility.
- Produce and maintain appropriate and comprehensive quality process specifications as required.
- Document and maintain in good order all relevant Quality assurance sections of Device Development History File and DMR as directed by Document Control
- Ensure adherence to HS&E activity and training for all reports to include a good level of housekeeping with all reports involved
TO ADHERE TO THE COMPANY’S PROCEDURES AS DETAILED IN THE CSOP MANUAL
KEY COMPETENCIES REQUIRED
- Demonstrate standards of leadership –
- Managing complexity
- Interdependent Partnership
- Credo Values
- Customer / Market Place Focus
- Culturally aware
- Team player
- Good influencing skills
- Project Management skills
- Good generalist (experienced quality person)
- Good communicator
- Politically sensitive
- Travel Flexibility
- Continuous Improvement Focus
QUALIFICATIONS & EXPERIENCE
- A primary Degree in Engineering or a related Science based discipline and demonstration of performance in a Quality Management role in a regulated industry for a minimum of 3 years.
- Minimum 5 years Quality Supervisory/Management experience in a Regulated industry, experience in Medical Devices would be an advantage
- Be able to demonstrate knowledge of current regulations relating to Medical Devices.
- Must be able to demonstrate the ability to interpret engineering specifications and procedures
- High degree of computer literacy is required
- Good negotiating skills
- Excellent planning and organisational abilities
- Good understanding of design and manufacturing principles desirable
THIS JOB DESCRIPTION IS NOT AN EXHAUSTIVE LIST OF THE JOB HOLDERS RESPONSIBILITIES.