The Quality Engineer will report to the Medication Management Solutions (MMS) Quality Engineering Supervisor, the Associate will provide quality engineering support to the applicable BD business segments including Quality, Operations, Post Market Services, Customer Advocacy and Marketing. Through suitable communication, effective problem solving and active vigilance on applicable requirements, the Associate will ensure product quality and compliance with all relevant global regulations, BD requirements and customer expectations. Success will be measured in terms of capacity to engage with suppliers, sub-contract manufacturers and internal customers to identify and address quality / compliance gaps and to maintain effective collaboration with the relevant functions within the BD organization.
The Quality Engineer will have the following responsibilities.
Develop as necessary and maintain collection, monitoring, review and reporting of supplier and sub-contract manufacturer quality measures.
Prepare and conduct internal and supplier quality audits and follow-up activities.
Raise, process and complete failure investigations plus corrective and preventive action CAPAs as needed both within BD and with supplier/sub-contract manufacturers.
Support and participate in the change order processes including as necessary, creation, participation in reviews and approvals.
Supports engineering projects by providing quality engineering as appropriate.
Create and revise component, sub-assembly and finished product inspection plans.
Assists in establishing, implementing and maintaining the Quality Management System (QMS)
Supporting the outsourcing of component and sub-assembly manufacture to third partly suppliers and sub-contractors.
Supporting the development and maintenance of supplier qualification/re-qualification activities for any new or existing suppliers or sub-contractors.
Collects, analyses (using statistically valid methods) and reports key performance indicators to key stakeholders, identifies areas for improvement, participates in continuous improvement projects by applying relevant methods.
Works with Supplier Quality to ensure timely resolution of supplier failures, corrective actions and preventive actions, in matters related to component quality deficiencies.
Competencies to include;
- Results-orientated and able to work both independently and within a team environment;
- High personal accountability & integrity;
- Passion to "make a difference" to health;
- Proactive, with the ability to take initiative using a 'can do’ attitude;
- Excellent interpersonal and communication skills with the ability to communicate and influence positively at all levels;
- Attention to detail in naming and filing of information is expected.
- Ability to build trust and engender strong relationships within BD and the supply chains;
- Ability to assimilate complex issues and to handle multiple priorities;
- Ability to challenge, collaborate and solve problems creatively;
- Must be focused and achievement oriented;
- Embodies trust, integrity and ethics inside and outside the Company;
- Self-motivated - demonstrates personal drive with a focus on meeting the expectations of BD’s customers;
- Demonstrates the ability to interact and cooperate with all BD employees both within the UK and international markets;
- Adherence to all policies and procedures.
- A relevant engineering degree or HND is preferred.
- Minimum of three years relevant experience in the medical device industry preferred with a focus on product and supplier quality activities.
- Experience of working within electrical/mechanical manufacturing environments is desirable.
- Knowledge of global medical device regulations.
- A qualified ISO9001 or ISO13485 lead auditor.
- A strong working knowledge of quality processes such as CAPA, complaint management, risk management, root cause analysis, statistical sampling plans, FMEA/Fault Tree Analysis.
- Capacity to work with information systems such as TrackWise, SAP ERP systems and the CAD system TeamCentre.
- Computer literate with proficiency in MS packages such as Word, Excel, Outlook, Visio and PowerPoint.
- Completed training in six sigma to green level or above would be advantageous.
- Medical Devices
- Root Cause Analysis
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