Quality Control Engineer

Job Description:

Summary:

Accountable to implement the planning for Quality on one product areas, looking to continuously improve the Quality performance of the site. Cares for the Quality Control of products and process. Creates the root cause investigations on top complaints, prioritize the failures to be attended and define the pertinent activities. Leads a PQ Team to have recurring cross functional meetings to identify barriers, trends, and opportunities.

Responsibilities:

• 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.
• Review and approve protocols for validation reports (IQ, OQ, PQ).
• Main partner in NPI process (Transference of products, CAPA Administration).
• Follow up on NCMR process.
• Test validation on product.
• Demonstrate drawing Reading for Specifications and Tolerances.
• Develop internal audits in process.
• PQT Presentation (KPI follow up).
• High communication Skills with all levels of the company.
• Problem Solving through evidence collected with Quality tools (RCCM, Statistical, DMAIC, Cpk, GR&R, PFMEA, 8D's, etc.)

• Professional engineering degree
• More than 3 years of experience in Quality function role or similar position (medical industry).
• English, intermediate level (able to maintain a conversation, and to make presentations at a satisfactory level).
• MS Office, Minitab, Agile, Oracle systems.
• Basic knowledge of QA QSR's: ISO 13485-2016, CFR part 820, Risk Assessment, FDA Class I & II.
• Good communication and negotiation skills.
• Good mindset and abilities to focus on customer needs and provide quick responses.
• Knowledge in a Problem-Solving technique tool