Reporting to the Quality & EHS Manager this position will be responsible for providing quality engineering support across multiple functions within Cambus Medical.
Duties and Responsibilities
• Ensure that Production operations within assigned area are completed in accordance with the requirements of our clients Quality System.
• Ensure all customer requirements are identified, documented, understood and met.
• Document manufacturing procedures, CHR’s, purchasing specifications, inspection procedures and standards etc… as required. Review and approve all updates to same.
• Ensure all processes are maintained in a validated state. Assess all changes for their impact on validations, product quality and the customer.
• Oversee the execution of validation activity, FMEA’s, OQ, PQ as required.
• Ensure all product/process quality issues that arise, including customer complaints, are effectively resolved in a timely manner using our clients CAPA system.
• Promote the need for continuous improvement within assigned area.
• Utilise, lead and mentor team members on structured problem-solving methods.
• Perform internal audits as per agreed schedule and assist with preparations for external audits.
• Keep your skills current and be conversant with the latest developments in quality and
regulatory systems which are relevant to the Company’s business.
• Participate in improvement activities, including Kaizen events, ensuring that quality requirements are followed during the change implementation process.
• Take on other duties which the Company may assign you from time to time.
• Must have a third level qualification in Engineering/Quality/Science.
• A minimum of 5 years’ experience in a regulated manufacturing environment.
• Knowledge and experience of process validations.
• Proven to be self-directed, self-motivated and able to prioritize workload.
• Must possess excellent verbal & written communication skills, which include but are
not limited to presentation, organizational and management skills
• Must have a working knowledge of statistics, SPC, and ideally the use of Minitab
• Knowledge of GMP & Regulatory requirements.
• Strong understanding of structured problem-solving techniques.
• A positive attitude in dealing with and mentoring people.
• An aptitude and drive for Continuous Improvement.
• IT skills – Microsoft Office, Minitab, ERP Systems