Quality Engineer

EQVAL Consulting Group, Inc. is a company that provides services to the manufacturing industry (Medical Devices, Pharmaceuticals, Biotechnologies, others).
We work with an extraordinary group of professionals (employees and contractors) to accomplish the requirements established by our customers, in order to perform and provide a highly effective service.
We are looking for a Quality Engineer to join our team!
The successful candidate will be responsible for generating master validation plan, PPM, risks and mitigations controls with PFMEA, and reviewing and approving validations.
The ideal candidate will have a strong background in engineering principles, excellent problem-solving skills, and an eye for detail.
Minimum Requirements: Bachelor's Degree in Engineering 3+ years of Experience Required Bilingual (Spanish and English) Knowledge and experienced on cGMPs Experience with equipment documents such as URS, FAT, IQ, OQ, PQ, TMV.
Experience with PFMEA & Regulations Strong communication skills (oral and written) Knowledge in: General Validation, Computer Software Validation, Investigation and root cause analysis skills with problem solving training.
Job Description: Requires 3+ years of knowledge or experience in pharmaceutical manufacturing environments or medical devices.
Requires good technical documentation skills, in English and Spanish.
Work reviewing and developing quality documentation and validations (including management of change processes, development, and execution of IQ, OQ, PQ protocols, etc).
Develop and implement quality control systems and procedures.
Work evaluating 'FMEA', both suppliers and manufacturing processes.
Develop and analyze statistical data and product specifications to determine present standards and establish proposed quality and reliability expectations of finished products.
Investigate customer complaints, identify root causes, and recommend corrective actions.
Analyze data to identify areas for improvement in the quality system.
Job Type: Full-time Benefits: Health insurance Personal Time Off (PTO) Professional Development Referral program Work Location: In person Powered by JazzHR