Job details
What you will do
The Senior Quality Engineer is responsible to establish, improve and maintain the quality system through the department of assigned projects. The main purpose of this position is to ensure the maintenance of the quality system to deliver only products that meet customer specifications and applicable regulatory requirements.
Main responsabilities:
- Monitor and analyze Quality key performance indicators (KPIs), implementing corrective and preventive actions to achieve strategic objectives.
- Maintain and update quality system procedures based on continuous improvement initiatives, customer feedback, KPI trends, and CAPA outcomes.
- Lead and participate in internal and external quality system audits to ensure compliance with GMP and regulatory requirements.
- Ensure proper product status identification and segregation of nonconforming materials throughout all process stages.
- Lead or support the implementation of quality and process analysis tools such as PFMEA, Control Plans, R&R, PDCA, RCA, SPC, and Cpk.
- Participate in change control activities and validation processes, including IQ, OQ, PQ, document control, and master validation plans.
- Oversee incoming material inspections and ensure timely calibration and accuracy of monitoring and measuring equipment.
- Lead CAPA activities from initiation to closure, ensuring effectiveness, regulatory compliance, and adherence to established procedures.
What you need
Required:
- Bachelor of Science, Engineering or related subject.
- Minimum 5 years of experience in quality, manufacturing, product transfer, and/or validations in highly regulated industries.
- Fluent in both English and Spanish.
- Proficient in MS Office Suite (including Word, project, Excel, and Power Point, teams)
- Knowledge of ISO 13485.
Preferred:
- Strong knowledge of Quality Concepts and Risk Based Techniques (e.g. FMEA, Risk, Statistics).
- Advanced degree/Lean Six Sigma training.
- Basic knowledge of sterile devices.
