Quality Engineer
Location: Sligo, IE
Department: Operations/Production/Manufacturing
Employment type: Full-Time
Shift: On site
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.
#J-18808-Ljbffr