For engineering services in the Manufacturing area.
WHAT MAKES YOU A FIT: The Technical Part:- Bachelor's Degree in Mechanical, Biomedical, Industrial or Chemical Engineering, and five (5) years of exposure within the Medical Devices Industry.
- Bilingual: Spanish and English
- Soft Skills: Excellent teamwork skills
- Shift: 1st and according to business needs.
- Experience in:
- Equipment & Process Validation
- Quality Systems & Change Control
- Regulatory Compliance & Manufacturing Change Management
The Personality Part: - Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients, and team members. In other words, being a customer service pro is one of your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to Be The Piece?
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)- Develops, modifies, applies, and maintains quality standards and protocol for processing materials into partially finished or finished materials products.
- Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
- Devises and implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
- Designs or specifies inspection and testing mechanisms and equipment.
- Conducts quality assurance tests.
- Performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards.
- Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
- May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control, and/or research.
- Expertise in developing, reviewing, approving and executing validation strategies and deliverables associated with equipment qualification (IQ/CSV/OQ/PQ), equipment decommissioning, process validation, cleaning validation, and cleanroom qualification activities in GMP-regulated environments.
- Strong knowledge of Quality Management Systems (QMS), including change control, risk management, nonconformance investigations, and assessment of quality impact resulting from equipment, facility, and process changes.
- Experience evaluating regulatory impact associated with facility modifications, equipment relocations, and process changes, ensuring compliance with FDA, ISO 13485, and applicable global regulatory requirements.
Are you the Next Piece?
