**Summary**:
Accountable for the administration of the cleanroom and the implementation of GMP protocols. Controls the execution of the master Quality plans for the assigned products. Pursues to continuously improve the Quality performance of the area. Creates the root cause investigations on top complaints, prioritize the failures to be attended and define the pertinent activities. Leads a PQ Team to identify barriers, trends, and opportunities for solutions.
**Essential Duties and Responsibilities**:
- Lead the Quality strategy of the cleanroom (ISO Class 8).
- Creation and update of protocols, procedures, and policies to fulfil the respective regulations and ISO standards.
- Perform validations, verifications, and revalidations of the cleanroom process.
- Direct contact with external suppliers and customers.
- Verify the outcome of the sterilization process to guarantee the sterile integrity of the product.
- Ensure the steps of the manufacturing process that are critical for the sterilization (material handling, assembly, packaging, etc.)
- Ensure critical controls dose audits, cleanroom certification, microbiology surveillance, particle monitoring, etc.
- Create quality plans with acceptance criteria for inspection, assuring compliance with specific requirements of the product.
- Supervise and study CPM's of products in charge to generate analysis for trend and Pareto charts.
- Develop and coordinate action plans to tackle highlighted complaints.
- Follow up on NCMR process.
- Test validation on product.
- Develop internal audits in process.
- Presentation for KPI's continuous improvement.
- Create, coordinate, and follow up on CAPA's.
- Problem Solving through evidence collected with Quality tools (RCCM, Statistical, DMAIC, Cpk, GR&R, PFMEA, 8D's, etc.)
**Qualifications**:
- Professional degree
- More than 3 years of experience in Quality function role or similar position (medical industry).
- Minimum 1 year of experience on the cleanroom operation and control.
- Proficient knowledge of related Quality standards ISO 13485-2016, ISO 14644, ISO 11135, etc.
- Proficient knowledge of regulations CFR part 820, Risk Assessment, FDA Class I & II, GHTF, etc.
- Good communication and negotiation abilities.
- Knowledge of sterilization and types of it (Gamma, ETO, etc.)
- Good mindset and aptitude to focus on customer needs to provide quick effective responses.
- Skillful on Problem-Solving and statistical tools.
- English, advanced level (conversational, and to able to do corporate presentations)
- MS Office, Minitab, Agile, Oracle systems.
COVID-19 considerations:
All visitors are required to wear a mask, temperature is taken at the entrance.
**Education**:
- Bachelor's (preferred)
**Experience**:
- QC Engineer - CLEAN ROOM: 3 years (preferred)
Work Location: One location
