Are you recruiting?
Advertise now
Harmac
SUMMARY: Reporting to the Quality Engineering Manager, the Senior Quality Assurance
Engineer will provide experienced ongoing Quality support to maximise production quality
performance, including identifying root cause, implementing corrective/preventive action on all
quality issues in production. Scope of role will also include addressing any customer and internal
related issues identified in the manufacturing process and validation of new processes/products
ensuring effective implementation of the required QMS documentation.
Requirements:
• Adhere strictly to company policies and procedures.
• Expert understanding of Harmac products and processed within the area of responsibility.
• Conform to the requirements of the Quality and Environmental Management System.
• Review, update, maintain and improve existing Quality Management processed and
procedures.
• Perform an active role in further development and continuous improvement of the
Quality Management System.
• Maintain detailed and accurate quality records, data analysis and documentation.
• Raise Quality profile and operating standards within the business.
• Deliver on all KPIs that help the business achieve its goal.
• Support projects and initiatives across the plant where required, ensuring key
deliverables are achieved in a timely manner and liaising effectively with internal and
external customers.
• Initiate and drive continuous improvement opportunities/programs.
• Lead and drive QA initiatives within area of functional responsibility.
• Represent quality interests and concerns on project teams.
• Quality support within the assigned Customer and/or project teams to ensure Customer
and QMS requirements are implemented and fulfilled to required GMP standards.
• Lead Quality Engineering activities for the introduction of new product lines through
development of product inspection plans, production documentation, process FMEAs and
risk management plans. Ensure change requests are effectively managed.
• Lead Quality Engineering activities for existing product lines through maintenance and
continuous improvement of product inspection plans, production documentation,
process FMEAs and risk management plans. Ensure change requests are effectively
managed.
• Ensure that products meet Harmac's and customers’ quality and product integrity
requirements and continually seek to identify and drive improvements in product and
process quality.
• Lead and coordinate/execute process and product; and sterilisation validations. Quality
peer review of functional area validation documentation.
• Provide quality input to cross functional team to support existing product lines with an
ability to multi-task and to work in a high paced environment with an awareness of
continued impact on production and the plant performance.
• Ensure quality standards are adhered to, and all production processes are carried out
according to procedures.
• Lead root cause investigation of quality issues and following through with timely and
effective corrective actions to prevent re-occurrence for customer and internal issues.
• Oversee non-conforming material, customer complaints, CAPA investigations, analysis,
and improvement.
• Utilize data analysis and trending, statistical process control, root cause analysis and
implement corrective actions.
• Utilize DOE’s and other statistical analysis to support product and process optimization or
determine causes of process variation.
• Ensure quality inspection instruments are accurate and regularly calibrated, tested and
audited.
• Assist with ensuring that the Company retains ISO accreditation.
• Conduct internal audits and external audits as required.
• Host audits of the Company’s operations by external bodies (e.g. audits from customers,
FDA, audits relating to certification to official standard e.g. ISO 13458)
• Train and mentor Graduate, Junior and Quality Engineers on policies and procedures and
perform an active role in their development and growth.
• An excellent record of attendance and time keeping.
• Familiarize yourself with a variety of processes to allow you to work across a number of
product lines
• Other tasks as directed in line with company goals and objectives.
"Guided by the disciplines of due diligence and compliance in all aspects of work.
• To be a good team member, fully motivated to achieve and demonstrate best practices
in line with the department and site objectives.
• Conform to the requirements of the quality and environmental management system.
• Effective communicator and influencer across multi-functional teams, with the ability to
manage internal and external customers’ requirements.
• Proficient with Microsoft Office.
• Proficient with Syspro, Minitab & Lotus Notes, is desirable.
• Knowledge of ISO 13485, ISO 14971 and QSR 21 CFR Part 820 standards.
• Excellent interpersonal skills.
• Ability to work in a cross functional team.
• Strong proficiency in statistical analysis techniques to investigate and solve problems and
improve quality.
• Self-driven and requiring minimal supervision.
• Ability to drive projects to completion.
• Project Management training is advantageous, with experience working on projects from
conception to completion.
Level 8 or equivalent Degree in Quality Assurance or similar discipline"
Level 8
