Reporting to the Site Quality Assurance Lead, the main focus of the role is primarily to ensure the quality standards are met. In this role you will form part of a cross functional team involved in Assembly. You will be working in both manufacturing (assembly) & non-manufacturing (QMS process based) setting. You will also have authority for 3 Quality Inspectors, by completing probation reviews, performance reviews and providing direct coaching and support.
What You Will Do In Your Role
- Motivate staff by promoting a positive environment where achievements and accountabilities are acknowledged and open two-way communication encouraged.
- Provide input from a quality perspective to product & process risk assessments, pFMEA.
- Perform and provide support to validations, metrology, document control, internal auditing.
- Interact directly with vendors and customers.
- Liaise with other departments as required as part of day-to-day activities.
- Perform process control monitoring & improvement activities.
- Work & report on CAPA, vendor CAPA, MRB, customer complaint activities.
- Support all steps of the change control and NPI processes, mainly: initial quality assessment, vendor selection assessment and qualification and validation requirements.
- Take part in Pilot Production & Product Approval, as well as reviews of Quality & Regulatory requirements.
The Experience You Will Bring
- Bachelor's degree or equivalent in Quality, Engineering, Science or related discipline with past working experience in this area.
- Knowledge of ISO 13485 or ISO 9001.
- Auditor's experience: internal or external or customer's audits.
- Responsibility for successfully accomplishing work objectives and delivering business results; ability of setting high standards of performance for self and others.
- Able to find opportunities to improve and extend contribution to the organization.
- Ability to demonstrate the highest commitment to integrity and showing respect for and value all individuals for their diverse backgrounds, experiences, styles, approaches and ideas.
- Strong organizational skills: ability to define, delineate roles and responsibilities effectively, plan well, facilitate change, optimize quality and productivity.
What Will Put You Ahead
- Previous experience preferably in a medical device manufacturing environment.
- Knowledge of ISO 14971.
- Experience with ERP systems, preferably SAP.