Position Summary

The Site Quality Engineer II will be responsible for a variety of site Quality activities to ensure compliance with applicable quality objectives and regulatory requirements and will be located at our sites in Miami, FL. This role will report to the Manager, Quality Operations.

Essential Duties & Responsibilities

• Direct efforts in risk identification and mitigation activities as part of evaluating site-related nonconformances, CAPAs, changes, or complaint investigations
• Support site teams in conducting investigations, including root cause analysis, corrections, corrective actions, preventive actions, and monitoring effectiveness
• Use of quality tools, such as 6Ms, 5-Why's, FMEA's, DMAIC, Cause and Effect Diagrams, Process Mapping, etc.
• Nonconformances: Coordinate quality review and approval of the site's nonconformances. Contribute with investigations and Root Cause Analysis, for the site.
• Evaluate, review, and coordinate QA approval of site-related investigations to ensure completion is appropriate to the level/ classification of the event
• Perform routine floor presence to ensure compliance with GMP, GTP, SOPs, and company procedures.
• Reinforce GMP, Quality System, and compliance expectations through coaching and floor interactions.
• Act as a key quality resource for the site, driving a culture of quality, continuous improvement, and adherence to the One Team mindset
• Review of incoming inspection results, certificates of analysis (CoA), and supplier documentation to confirm materials meet defined specifications and regulatory requirements
• Change Controls: Support initiation, evaluation, and completion of changes impacting the site to ensure timely and satisfactory implementation of changes by all departments at the site. Review and approve site-specific protocols and reports as part of changes
• CAPA program: Support and monitor all CAPAs related to the site to ensure implementation is completed according to the established procedures and policies
• Provide site QMS metrics information to the QMS team in support of Quality Management Review
• Support Internal Audits as requested by management
• Collaborate with cross-functional departments to ensure timely implementation of quality systems
• Other Duties as assigned

Skills & Abilities

Essential Duty Definition:

• Working knowledge of electronic Quality Management Systems
• Working knowledge and ability to apply GTP's and GMP's in conformance to U.S. standards
• Ability to effectively negotiate and build collaboration amongst individuals
• Proficient in MS Word, Excel, Power Point and other applications. Familiarity with electronic systems for ERP and Quality Management Systems

Position Expertise/Qualifications

• BS degree in biomedical engineering, engineering, biological sciences or related field

Physical Requirements

• Sedentary work that generally requires sitting and/or standing