- To proactively protect the customer through ensuring that all products are manufactured to the highest standards and under the highest GMP conditions.
- Demonstrates commitment to the Quality Policy (patient safety and product quality) through the daily execution of sound quality practices and the maintenance of an effective quality system.
- Manage all quality related activities for finished device manufacturing and participate in Site & Corporate initiatives.
- Understands and complies with all regulations governing the quality system.
- Ensures the quality operations team are aware of their commitment to patient safety and product quality, are current with their training requirements and that they understand and comply with all other regulations governing their work.
- Leads and demonstrates expertise in the areas of QSR and ISO standards within one’s own group, constantly promoting awareness of best industry practices and making appropriate decisions on a daily basis.
- Ensure compliance with the quality management system in all activities within our client’s site
- To support audits from external regulatory agencies (FDA, BSi) and customers and to lead preparation activities in advance of such audits.
- Ensure all customer queries and concerns are professionally addressed in a timely manner.
- Drives continuous improvement initiatives to enhance the site quality system and product quality ensuring compliance with governing regulations and corporate policies and procedures.
- Develops and manages a high-performance quality engineering team. Creates a strong team working environment with a focus on customer needs, compliance, product quality, and risk mitigation.
- Delivers process improvements that reduce cost or improve the quality of the product.
- Develop strong links with customer organisations.
- Participate in new product introductions to ensure quality is built into all products early in their life cycle.
- Ensure effective and efficient process controls are implemented and maintained (inspection standards, plans, frequencies and test methods).
- Has the responsibility and independent authority to make decisions related to product quality, including the disposition of the non-conforming product.
- Participates in Customer Complaints investigation for areas under their control and escalates critical issues as appropriate.
- Drives robust and effective corrective and preventive action programs through the CAPA system.
- Provides best in class problem-solving tools.
- Facilitates root cause investigations for online QA issues.
- Expected to play an active role in the execution of the site Quality Excellence Program particularly those projects identified to drive quality system effectiveness.
- Works cross-functionally to deliver on the site strategic targets and objectives.
- Ensures staff are trained to perform effectively their work and their training is documented.
- The majority of the work will be spent on-site in a manufacturing / cleanroom environment
- There may be a requirement as part of the role to travel.
- A graduate of Engineering, Sciences or equivalent qualification.
- Proven track record in a similar role with a minimum of 5-8 years’ experience at that level within the Medical Device or related industry
- Excellent “hands-on” technical skills.
- Good coaching/mentoring skills.
- Excellent communication and interpersonal skills and have demonstrated the ability to lead in a previous role.
- Experience in people management and development.
- Strong team building skills with proven abilities in decision making and sound personal judgment
- Good organization, supervisory and investigation skills are required.
- Proven ability to influence
For a confidential discussion and more information on the role/company please email your CV to: email@example.com