Manufacturing Quality Assurance Specialist
This role involves overseeing quality assurance across manufacturing processes and external suppliers, including contract manufacturers.
Key Responsibilities:
* Oversee electronic and system-level production to ensure compliance with industry standards
* Lead root cause investigations and manage CAPAs to maintain high-quality products
* Support process validations and documentation reviews to ensure regulatory compliance
* Manage supplier quality performance and participate in audits to identify areas for improvement
* Drive continuous improvement initiatives and support internal/external audits to ensure adherence to quality standards
Required Qualifications:
* Bachelor's degree in Engineering or a related field
* 3-7 years of experience in QA or manufacturing in a regulated industry (preferably medical devices)
* Experience with CAPA, non-conformances, and process validation
* Strong knowledge of ISO 13485 and FDA QSR regulations
* Excellent communication skills and attention to detail
Desirable Skills:
* Experience with contract manufacturers
* Certifications such as CQE, Six Sigma, or Auditor
* Familiarity with QMS/ERP systems such as Greenlight Guru or MasterControl
For more information, contact the hiring manager directly.
Reperio Human Capital acts as an Employment Agency and an Employment Business.
Seamus O'Rawe is recruiting for this role.
Get in touch with Seamus O'Rawe for more information: