Quality Engineer/Specialist

Flexible & Integrated Technical Services, LLC•Añasco, PR

8d•Onsite

About The Position

This role is for Quality services in the Manufacturing area. The ideal candidate will have a Bachelor’s Degree in Engineering or a related field with at least four (4) years of experience in Audit Observations, Investigations & CAPA activities within the regulated industry. The position requires bilingual skills in Spanish and English. The shift is administrative and according to business needs. The role involves initiating Non-conformances (NRs), performing investigations for NRs/CAPAs and Audit Observations in ETQ, planning and executing product disposition, and managing actions related to NC/CAPA & Audit Observations, ensuring timely closure of investigations and product dispositions. The Quality Engineer/Specialist will identify and escalate compliance issues to Operations Managers, review and analyze quality trends with the manufacturing team, provide direction for process enhancement based on quality trends, and lead cross-functional teams to ensure non-conformance causes are identified and corrective/preventive actions are implemented effectively. This includes evaluating the effectiveness of implemented actions against trends, leading investigations of negative trends, and facilitating implementation processes in alignment with the Process Engineer and Manufacturing Manager. The role also involves analyzing data to recommend actions for process, equipment, and system improvement.

Requirements

Bachelor’s Degree in Engineering or related field
At least four (4) years of previous exposure to Audit Observations, Investigations & CAPA activities within the regulated industry.
Bilingual: (Spanish and English)
Experience in NC/CAPA & Audit Observations process
Experience in FDA 21 CFR and global medical device regulations and standards
Experience in GMP & GDP regulations

Nice To Haves

Treats everyone they meet like family, especially our resources, clients and team members.
Customer service skills
Innovative thinking
Delivers top-quality results

Responsibilities

Initiate NRs as required.
Perform the investigations in ETQ for NRs/CAPAs and Audit Observations for Operations.
Plan and execute product disposition.
Plan and execute actions related to NC/CAPA & Audit Observations.
Close the investigations and Product Dispositions on time.
Identifies and escalates to Operations Managers any compliance issues and their potential impact across the franchise so that they can be effectively resolved.
Reviews and analyzes quality trends with the manufacturing team.
Considering quality trends provides direction in setting work priorities for process enhancement.
Provides leadership and guidance to cross-functional, multilevel technical teams to ensure that 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 the effectiveness of the same.
Leads investigations of the negative trends and, in alignment with the Process Engineer and the Manufacturing Manager, facilitates the implementation process.
Analysis of data and based on the trends recommends actions for process, equipment, and system improvement.