Quality Engineer

12 Month Contract

JOB PURPOSE

Amcor Flexibles’ Sligo is seeking an experienced Quality Engineer to join our team. The Quality engineer needs to be a champion of the quality process and a key contributor to support the management and development of the quality department . The role reports to the Quality Manager and works closely with operations, management and other key stakeholders both internal & external.

Principal Accountabilities

• Establish quality systems and standards, which enable achievement of regulatory compliance and good manufacturing practices
• Strive to promote quality interests while making manufacturing processes run in a stable, efficient & reliable environment.
• Ensure the implementation of systems like ISO 13485 to maintain quality in daily operations
• Prepare, maintain, review and approve documentation and records required for compliance to the QMS and regulation.
• Ensure awareness and participation in specific activities related to GMP/GDP
• Manage change control.
• Evaluate and coordinate customer complaints and rejects to solve issues of customers by taking preventive and corrective actions.
• Coordinate programmes for measurement and continuous improvement of quality e.g. . Material review board/ Change control Board /Customer Complaints cross functional teams
• Oversee and participate as required in internal, customer and regulatory audits of site
• Manage the CAPA process using problem solving tools within a team environment.
• Support the co-ordination of management monthly reporting and annual management review.

• Ensure risk is assessed, mitigated and managed through the QMS by performing and documenting risk assessments

• Generate, execute, review, and approve master and completed qualification and validation protocols, summary reports and associated data
• Prepare products for qualifications studies and executes qualification and validation studies
• Analyse the results of validation testing and determines the acceptability of results against pre-determined criteria
• Prepare Gauge R&R and attribute studies for measurement system analysis.
• Manage the metrology process and the calibration schedule.
• Assure the quality standards agreed with customers are achieved through review of customer specification and implementation of internal updates.
• Support growth of knowledge and encourage an environment of knowledge sharing by providing leadership and support to quality team members
• Develop and lead the company Quality Strategy to implement a Quality policy that enables the manufacture of high quality and safe products.
• Overview robust systems for product release/disposition of non-conforming material and management of stock with quality status and ensure business wide awareness for compliance
• Communicate specific quality & technical requirements to all parts of business as applicable
• Determine and implement quality strategies for new products, technologies and assets to support the business in its ongoing growth
• Demonstrate and foster Amcor Values and actively contribute to a high-performance culture.
• Complies with all company policies and procedures.
• Meet or exceed plant business plan and KPI’s.

QUALIFICATIONS: 

• Bachelor’s degree in engineering, science or a related field.
• At least 5 years’ experience in a manufacturing company at different levels and functional areas, mainly in Quality Assurance, Quality Control and other relevant areas (i.e. engineering, R&D)
• Applied knowledge of Lean CI and change management methodology
• Excellent communication skills in a multi-national environment
• Advanced influencing/negotiating/persuading skills,
• Experience in quality audits an advantage,
• Proven leadership ability
• Familiarity with ISO 13485, QSR, GDP, GMP desirable.
• Lean Six Sigma training a distinct advantage.
• Working knowledge of Process Validation and Computer Systems validation
• Understanding of the medical device environment desirable
• Good knowledge of problem-solving tools and risk evaluation and management

SPECIFIC SKILLS & ABILITIES

• Ability to work as an effective member of a high-performance team
• Excellent communication skills both oral and written to ensure clear alignment
• Ability to pay attention to details while meeting critical deadlines with ever changing priorities.
• Must have a positive attitude and open mindedness to new ideas.
• A self-starter who can prioritize their own work
• Proven ability to drive continuous improvement within a complex manufacturing business
• Cross culture awareness, sensitivity, and effective communications within a global organization.
• Ability to build strong working relationships with relevant persons (plant and corporate alike).
• Must demonstrate a strong work ethic, reliability, trustworthiness, a capacity, and willingness to learn, and respectfulness towards co-workers.