Company Description
EGMA is a leading innovator in ophthalmic lenses, revolutionizing vision care with precision and passion. We empower optical businesses to see the future clearly and strive for excellence in quality assurance.
This is a full-time on-site role for a QA Specialist at EGMA, you'll play a key role in ensuring that our production processes run smoothly and meet the highest quality standards. Your job will involve conducting internal audits, managing Corrective and Preventive Actions (CAPA), and overseeing compliance with regulatory frameworks like ISO 9001, ISO 13485, and CE Marking.
You'll also take charge of handling customer claims, ensuring our products not only meet but exceed expectations. With the Compliance Officer role now integrated into your responsibilities, you'll also be managing regulatory compliance and preparing for audits. You'll be part of a collaborative team, working alongside QA and QC teams to keep improving the way we do things.
Duties and Responsibilities:
1. Internal Auditing & Compliance
- Conduct internal audits to make sure our production processes align with ISO 9001, ISO 13485, and CE Marking standards.
- Spot any non-conformities and work with the QC team to get things back on track quickly.
- Keep compliance reports up to date, making sure they're always ready for internal reviews and external audits.
- Stay informed about the latest regulatory changes and make sure EGMA is always compliant with local and international regulations.
2. Managing CAPA & Continuous Improvement
- Lead the CAPA process, ensuring that any quality issues are properly identified and resolved to prevent future problems.
- Keep track of CAPA actions to ensure everything is completed on time.
- Work closely with the QA Engineer and production teams to identify opportunities for improvement, helping us become more efficient.
- Be involved in Kaizen initiatives and other projects that focus on making our processes better.
3. Customer Claims Management
- Oversee customer claims, ensuring that complaints are handled quickly and effectively.
- Perform a thorough root cause analysis to understand why the issue happened and how we can prevent it from happening again.
- Make sure all documentation related to claims is up to date and that corrective actions are followed through.
4. Regulatory Compliance (Previous Compliance Officer Duties)
- Ensure full compliance with ISO 9001, ISO 13485, CE Marking, and other relevant regulatory standards.
- Prepare for external audits, working closely with auditors and regulatory bodies to ensure everything is in order.
- Conduct risk assessments to identify potential issues and create action plans to address them.
- Keep all compliance-related documents up to date and available for any audits or inspections.
5. Documentation & Reporting
- Keep detailed records of audits, CAPA initiatives, customer claims, and compliance reports.
- Prepare regular updates for the QA Engineer on audit results, compliance statuses, and any ongoing corrective actions.
- Ensure proper document control, making sure everything is filed correctly and available when needed.
6. Training & Quality Awareness
- Assist the QA Engineer with delivering training programs on quality standards, compliance, and CAPA processes.
- Promote quality awareness across the team, helping to create a culture of continuous improvement.
- Provide training to ensure all staff understand and adhere to the latest ISO standards and internal SOPs.
Education and Qualification:
Diploma in engineering, quality management, or a related field.
- At least 5 years of experience in quality assurance, compliance management, or auditing within a manufacturing environment.
Skills and Competencies:
- A strong background in ISO 9001, ISO 13485, and regulatory compliance is essential.
- Audit and Compliance Knowledge: Strong understanding of ISO 9001, ISO 13485, and CE Marking.
- Problem-Solving: Strong analytical skills, with an ability to pinpoint issues and create actionable solutions.
- Collaboration: Able to work effectively with teams from different departments, especially QC and production.
- Attention to Detail: Meticulous with documentation and compliance, ensuring nothing is overlooked.
- Communication: Excellent interpersonal skills, helping you work well with both internal teams and external auditors.
License and Certifications:
- ISO 9001:2015 Lead Auditor Certification (plus).
- ISO 13485:2016 Lead Auditor Certification (plus).
- Certified Six Sigma Green Belt / Black Belt for process optimization (plus).
- Occupational Health and Safety Certification (e.g., NEBOSH, OSHA) (plus).
Performance Metrics:
- Audit Compliance Rate:
- Target: 100%
- Ensures we meet all regulatory and audit requirements.
- CAPA Completion Rate:
- Target: 100% within 30 days
- Helps us address issues effectively and prevent them from happening again.
- Customer Complaint Resolution:
- Target: Less than 7 days to resolve
- Ensures customer satisfaction by quickly resolving claims.
- Regulatory Risk Assessment Completion:
- Target: Complete 100% quarterly
- Helps identify and mitigate any potential compliance risks.
- Training Completion Rate:
- Target: 100% of assigned staff trained within the required timeframe
- Ensures all employees are properly trained and up to speed on quality standards.
What we are looking for in the candidate:
- Flexibility: Comfortable with adjusting your schedule when needed to meet audit or production deadlines.
- Problem-Solver: Able to jump in and address quality issues quickly and efficiently, keeping the operation running smoothly.
- Commitment to Improvement: A proactive mindset that's always looking for ways to enhance processes and improve compliance.
