Quality Engineer - Investigations/CAPA

• Bachelor’s degree in Life Sciences or Engineering and a minimum of two (2) years of exposure in Process Improvements activities within the Pharmaceutical or Medical Device Industry.
• Excellent verbal/written communication skills (English and Spanish)
• Requires strong communication, interpersonal and negotiation skills.
• Shift: According to business needs (Must be available for all shifts and irregular hours)
• Experience in:

• QSR, GMP, ISO, applied statistics and failure mode analysis techniques.
• FDA 21 CFR and global medical device regulations and standards is required (including but not limited to MDD, MDR Regulations, International standards ISO 13485, ISO 14971, JPAL, Canadian, and Brazil Regulations).
• Documentation (Technical reports) & Presentations

• Perform the investigations in ETQ for NRs/CAPAs and Audit Observations for Operations.
• Plan and execute product disposition, actions related to NC/CAPA & Audit Observations.
• Close the investigations and Product Dispositions on time.
• Identifies and escalate to Operations Managers/Director any compliance issues and their potential impact across the franchise so that they can be effectively resolved.
• Reviews and analyses quality trends with the manufacturing team.
• Considering the quality trends provides direction in terms of setting work priorities for process enhancement.
• Provides guidance to manufacturing supervisors to ensure that effective in-depth investigations are performed.
• Provides leadership and guidance to cross functional, multilevel technical teams to assure causes of non-conformance are identified and understood and that sound corrective/preventive actions are implemented.
• Evaluation of the implemented corrective and preventive actions against trends to assess effectiveness of the same.
• Leads /support continuous improvement actions to eliminate, reduce or mitigate failure modes in manufacturing processes.

Flexible & Integrated Technical Services, LLC