Posted: 18 June
The role
Role Overview
The primary purpose of this position is to perform engineering work involving established quality engineering methods, tools, and techniques within a regulated manufacturing environment. You will apply quality and engineering principles to investigate and resolve product and process issues while supporting continuous improvement initiatives. Working under the guidance of experienced engineers and managers, you will help ensure internal and external customer requirements are consistently met.
You will comply with all applicable quality, safety, environmental, security, and regulatory requirements, including quality management systems, company policies, operating procedures, and relevant industry regulations.
Manufacturing and Process Support
Support regulatory inspections, audits, investigations, and inquiries related to product design and manufacturing quality.
Monitor manufacturing activities for assigned products to ensure compliance with approved documentation and quality requirements.
Review and assess changes to product structures, manufacturing documentation, specifications, risk assessments, control plans, and related records.
Participate in continuous improvement and operational excellence initiatives.
Assist with product and process transfer activities.
Support technical projects focused on product and process improvements using established quality and manufacturing methodologies.
Collaborate with cross-functional teams to exchange information, solve problems, and support engineering development.
Test Methods and Validation
Development, execution, and documentation of test method validation activities.
Partner with manufacturing and process engineering teams to review processes for new and existing products.
Coordinate process validations, capability studies, and monitoring activities where appropriate.
Develop inspection techniques and procedures to ensure products meet design and quality requirements.
Create, review, approve, and implement inspection procedures for incoming, in-process, and finished products.
Non conformance and Corrective Action Support
Ensure nonconforming material is properly evaluated and dispositioned in accordance with established procedures.
Lead product complaint and investigation activities.
Participate in corrective and preventive action (CAPA) processes, including trend analysis and root cause investigations.
Analyze quality data from complaints, suppliers, manufacturing processes, and training effectiveness programs.
Apply structured problem-solving and statistical analysis techniques to identify root causes and support improvements.
Quality Systems Support
Support internal quality audits and quality system activities.
Promote a culture of quality ownership and compliance.
Contribute to quality performance objectives through participation in investigations, corrective actions, and continuous improvement efforts.
Perform additional duties as assigned.
Operational Excellence Support
Support site and departmental quality objectives, validation plans, and performance metrics.
Assist with change management activities and customer notification processes where required.Promote workplace organization, visual management, standard work practices, and effective training programs.
Support employee engagement through structured problem-solving, safety initiatives and improvement programs.
Contribute to process optimization through the application of quality-by-design and built-in-quality principles.
Performance Measures
Performance indicators may include, but are not limited to:
Compliance with safety and environmental requirements.
Demonstration of organizational values and professional conduct.
Achievement of assigned project goals and milestones.
Quality performance metrics such as complaint rates, nonconformance trends, and corrective action effectiveness.
Participation in innovation, continuous improvement and process optimization activities.
Qualifications
Education
Bachelor's degree in Engineering or a related technical discipline with relevant industry experience.
Equivalent combinations of education and experience may also be considered.
Skills
Strong technical aptitude and analytical problem-solving ability.
Effective written and verbal communication skills.
Ability to work successfully in a fast-paced manufacturing environment.
Positive, proactive approach to problem solving and continuous improvement.
Strong attention to detail and commitment to quality.
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