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About the role
Key responsibilities & impact- Establish quality systems and standards, which enable achievement of regulatory compliance and good manufacturing practices.
- Strive to promote quality interests while making manufacturing processes run in a stable, efficient & reliable environment.
- Ensure the implementation of systems like ISO 13485 to maintain quality in daily operations.
- Prepare, maintain, review and approve documentation and records required for compliance to the QMS and regulation.
- Ensure awareness and participation in specific activities related to GMP/GDP.
- Manage change control.
- Evaluate and coordinate customer complaints and rejects to solve issues of customers by taking preventive and corrective actions.
- Coordinate programmes for measurement and continuous improvement of quality e.g. Material review board/Change control Board/Customer Complaints cross functional teams.
- Oversee and participate as required in internal, customer and regulatory audits of site.
- Manage the CAPA process using problem-solving tools within a team environment.
- Support the co-ordination of management monthly reporting and annual management review.
Requirements
What you’ll need- Bachelor’s degree in engineering, science or a related field.
- At least 5 years’ experience in a manufacturing company at different levels and functional areas, mainly in Quality Assurance, Quality Control and other relevant areas (i.e. engineering, R&D)
- Applied knowledge of Lean CI and change management methodology
- Familiarity with ISO 13485, QSR, GDP, GMP desirable.
- Lean Six Sigma training a distinct advantage.
- Working knowledge of Process Validation and Computer Systems validation
- Understanding of the medical device environment desirable
Benefits
Comp & perks- Health insurance
- 401(k)
- Flexible working hours
- Paid time off
- Opportunities for professional development
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
ISO 13485Lean CIchange managementProcess ValidationComputer Systems validationLean Six Sigma
Soft Skills
problem-solvingteam collaborationcommunicationorganizational skills