Quality Assurance Specialist
4 days ago
We are a leading electronic manufacturing company specializing in the production of PCBS (Printed Circuit Boards). Our commitment to quality and customer satisfaction has earned us strong, stable growth over 40 successful years.
Job DescriptionJob Title: Quality Systems Specialist
Reports To: Director of Quality
Department: Quality Management
Shift: 8:30 AM – 5:00 PM (Monday – Friday, fully in office)
Key Responsibilities:
- Monitoring and maintaining/updating applicable procedures, work instructions and controlled documents of the company QMS
- Assist and stay up to date with Quality and Regulatory compliance
- Conduct Internal Quality Audits across company sites and support the audit program
- Review and analyze data and company metrics/KPI for continuous improvement
- Participate in risk management activities and risk mitigation implementation in products and processes
- Monitor and evaluate suppliers, supplier quality issues and supplier performance; Provide support for the supplier management program including supplier audits
- Perform product inspections to specified requirements and/or IPC standards
- Participate in documentation and investigation activities related to customer complaints
- Perform process and software validation activities
- Provide preparation and support for on-site management review meetings
- Assist during external ISO (Registrar) audits and regulatory inspections
- Other duties as assigned
Qualifications:
- Minimum 3 years' electronics manufacturing environment or medical device experience with strong quality auditing skills
- University degree, preferably in engineering or sciences with Quality Assurance background
- Knowledge of device regulations and its applications such as International Standards, FDA i.e. ISO 9001:2015, AS9100D, ISO 13485:2016
- Excellent knowledge of MS Office applications (Excel, PowerPoint, Word, Visio, etc.)
- Ability to read, analyze and interpret documents
- Ability to write well and effectively communicate
- Organized and attention to details
- Able to prioritize responsibilities and multi-task
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