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Systems Quality Engineer - County Cork
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Systems Quality Engineer - County Cork.
OBJECTIVES OF POSITION:
• Supports FDA’s Quality System Regulations, ISO 9000, ISO 13485 as well as all international standards relevant to customer products for the manufacturing facility.
• Own Event Investigation process and support CAPA system compliance ensuring timely closure of all customer investigations.
• Support all product and process audits as per company procedures.
• Responsibility for Corporate SOP alignment and compliance ensuring all site documents are kept aligned and completed on time & interact and support Regulatory Compliance Officer in key tasks.
• Support Quality Leadership team in key site projects and support critical customer issues and investigations.
• Interact with regulatory agencies and assume a key role in supporting all audit streams.
• Flexibility to work across and support key Quality Department areas such as Customer Quality Engineering, Supplier Quality Engineering and relevant QMS activities such as Internal Audit program, Performance Excellence, Management review, Business Continuity Management, Key Quality Projects working with Lean Six Sigma and Operations Excellence Lead.
• Support right first-time introduction of any new products or processes introduced into the site.
• Write standard operating procedures as well as regulatory standard responses in event investigations.
• Make training presentations to internal employees at all levels as required.
• Support QMS lead in CAPA System and compliance.
• Support of internal audits and inputs to Management Review.
• Monitoring of processes, ensuring compliance to all relevant procedures and housekeeping is maintained.
• Support Quality leadership team where appropriate to improve Quality Systems and drive projects to support these Departments.
• Assure ongoing compliance with quality and industry regulatory requirements.
Health & Safety:
• Ensure compliance with Health & Safety Legislation and Regulations.
Interested applicants should have:
Degree in a Quality related discipline or similar, including extensive knowledge of regulatory compliance and standards.
• ISO Lead Auditor training and extensive auditing experience an advantage.
• A minimum of 5 years' experience in quality assurance. Experience in medical device industry a plus.
• Good knowledge of current FDA Quality Systems Regulation, ISO 9000, ISO 13485, and MDSAP.
• Good interpersonal, writing and leadership skills.
• Must be a strong communicator and ability to multi-task and support areas where workload is heavy.
• Ability to create a team environment and assist all teams in problem solving.
• Ability to work independently and resolve any regulatory & site Quality investigations as they arise.
• Strong audit capability.
• Ability to read, analyse and interpret quality metrics, Corporate SOPs, Site SOPs and Customer Quality agreements and any associated legal documents during customer engagement.
• Ability to respond to common inquiries or complaints from internal customers and regulatory agencies.
• Ability to effectively present information to customer and internal personnel at all levels.
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