Quality Engineer II
Flexible & Integrated Technical Services View all jobs
- Juncos, PR
- Permanent
- Full-time
- Bachelor’s Degree in Engineering (preferred as Mechanical, Chemical, Industrial), and four (4) years of experience within the Medical Devices Industry.
- Bilingual: Spanish and English
- Soft Skills: Excellent teamwork skills
- Shift: 1st and according to business needs.
- Experience in:
- Reviewing and approving Validation test plans, reports, and deviations.
- Perform statistical analysis (Minitab) to support validations and product release.
- Risk Management documentation: pFMEAs, Equipment documentation: URS, FAT, IQ, OQ, PQ, TMV.
- Defining validation strategies.
- 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?
- 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 and performs statistical analysis to assess the cost and determine the responsibility for products or materials.
- Ensures that corrective measures meet acceptable reliability standards and that documentation complies with requirements.
- May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control, and/or research.