Senior Engineer l Manufacturing l Quality l QA

Responsible for leading key elements of the quality system to ensure compliance to ISO13485:2016 and other relevant standards as applicable. Responsibility and authority for product/process quality improvement programmes, analysis of quality costs, investigation and trending of customer complaints, analysis of quality waste, reliability evaluations and process capabilities studies.

• Coordination of quality-related activities on time and in full against agreed objectives. These may be in respect of Quality Systems, Converting Quality, Added Value Service Quality, or other topics as agreed with the Quality Manager
• Provide updates to Quality Manager on an agreed frequency
• Escalation to Quality Manager of any risks related to assigned responsibilities
• Generation of reports for data trending and analysis of the quality system (as required)
• With support of SME’s, conduct and/or coordinate actions to drive investigations, perform robust root cause analysis, develop and implement corrective and preventive actions and establish effectiveness monitoring plans as part of customer complaints, CAPA and non-conformances.
• Responsible for oversight and approval of all phases of assigned events and investigations
• Communication with customers on assigned responsibilities
• Preparation of reports to demonstrate completion of projects with associated data and conclusions
• Management of time, workload, performance and development of direct reports
• Ensure that Good Manufacturing Practices (GMP) and safe working practices are adhered to at all times, including wearing PPE as appropriate.
• Acquire knowledge of Health & Safety procedures, work instructions, and associated documentation. Comply with all Health & Safety Policies and instructions and actively contribute to Company efforts to promote safe behaviour and safe systems of work.
• Manage day-to-day project activities to ensure on time completion of projects.
• Build and maintain positive/professional working relationships and effective communication with internal cross functional departments
• Support site readiness for first, second, and third party audits (including unannounced audits)
• Support the scheduling of internal audits and conduct internal audits as part of the internal audit team
• Performs other duties as assigned. Will include participating in projects where required

Education:

• Third level qualification in science/ engineering.

Experience Criteria:

• Three years’ experience in Quality Engineering in a manufacturing environment
• Training and/or experience in working in a ISO13485:2016 certified manufacturing environment
• Previous people management experience
• Excellent planning and coordination skills
• Excellent verbal and written communication skills
• Excellent attention to detail skills
• Continuously seeks opportunity to improve and optimize the customer regulatory request process.
• High degree of safety awareness.
• Champions Quality
• Strong attention to detail

Salary - DOE
Job Type: Full-time

Benefits:

• Bike to work scheme
• Company pension
• On-site parking

Schedule:

• 8 hour shift
• Day shift
• Flexitime
• Monday to Friday
• No weekends

Ability to commute/relocate:

• Co. Offaly: reliably commute or plan to relocate before starting work (preferred)

Education:

• Advanced/Higher Certificate (preferred)

Experience:

• Quality: 3 years (required)

Work authorisation:

• Ireland (required)

Work Location: In perso

• Coordination of quality-related activities on time and in full against agreed objectives. These may be in respect of Quality Systems, Converting Quality, Added Value Service Quality, or other topics as agreed with the Quality Manager
• Provide updates to Quality Manager on an agreed frequency
• Escalation to Quality Manager of any risks related to assigned responsibilities
• Generation of reports for data trending and analysis of the quality system (as required)
• With support of SME’s, conduct and/or coordinate actions to drive investigations, perform robust root cause analysis, develop and implement corrective and preventive actions and establish effectiveness monitoring plans as part of customer complaints, CAPA and non-conformances.
• Responsible for oversight and approval of all phases of assigned events and investigations
• Communication with customers on assigned responsibilities
• Preparation of reports to demonstrate completion of projects with associated data and conclusions
• Management of time, workload, performance and development of direct reports
• Ensure that Good Manufacturing Practices (GMP) and safe working practices are adhered to at all times, including wearing PPE as appropriate.
• Acquire knowledge of Health & Safety procedures, work instructions, and associated documentation. Comply with all Health & Safety Policies and instructions and actively contribute to Company efforts to promote safe behaviour and safe systems of work.
• Manage day-to-day project activities to ensure on time completion of projects.
• Build and maintain positive/professional working relationships and effective communication with internal cross functional departments
• Support site readiness for first, second, and third party audits (including unannounced audits)
• Support the scheduling of internal audits and conduct internal audits as part of the internal audit team
• Performs other duties as assigned. Will include participating in projects where require