We’re seeking Project Engineer (3 positions) to work with one of our top medical device clients at Añasco, PR. With us, it’s all about finding the job that’s just right.
- Bachelor degree in Engineering. Preferably Industrial or Mechanical
- At least 1-3 years practical experience in a FDA regulated manufacturing environment, Preferred in a Medical Device Operation.
- Experience working directly with suppliers with raw materials. Project management and/or engineering experience preferred
- Preferred Knowledge: SPC, Lean/Six Sigma, JIT, TQC, GMP, QLP and Design Control applications. Ergonomic. OSHA and FDA regulations, Project management, cost control, and development of guidelines, trainings, and program. Strong product/process/material validations. Strong Project management Skills
- Computer and Software skills. Preferred Knowledge of Project Management Tools (e.g. Microsoft Project)
- Available Admin Shift, Monday - Friday 8am - 5pm.
- Plan and qualify changes in components and/or raw materials requested by the suppliers following applicable procedures.
- Coordinate and approve First Article Inspection of new and/or existing components and/or raw materials.
- Provide timely awareness to management of changes in components and/or raw materials requested by the suppliers, associated conflicts, unexpected events, or other situations that may impact the business continuity.
- Formally and effectively communicate potential misses at the time of discovery along with the date that a specific quantitative action plan will be available to recover from the missed commitment.
- Develop and issue change control documentation to address changes in components and/or raw materials requested by the suppliers following applicable procedures.
- Conduct technical and statistical investigation on supplier quality problems found during qualification process.
- Performs cost analyses and inventory projections as a result of engineering projects. Prepares cost and time estimates for engineering and project schedules.
- Generation and execution of validation plans, validation protocols, and completion reports. Provide statistical analysis of the data to support the reports.
- Evaluate, investigate and document non-conformances incidents and/or protocol deviations.
- Evaluate and determine appropriate actions to resolve conflicts and/or unexpected events as to prevent and/or minimize impact on business and product supply commitments.
- Complete assigned Non-Conformance and CAPA investigations and prepare investigation reports.
What happens next?
Once you apply, you’ll proceed to next steps if your skills and experience look like a good fit. But don’t worry—even if this position doesn’t work out, you’re still in our network. That means all our recruiters will have access to your profile, expanding your opportunities even more.
Helping you discover what’s next in your career is what we’re all about, so let’s get to work.
Kelly® SETT PR Offers!
- Exposure to a variety of career opportunities as a result of our expansive network of client companies
- Career guides, information and tools to help you successfully position yourself throughout every stage of your career
- Access to more than 3,000 online training courses through our Kelly® Learning Center
- Weekly pay
- Sick, Vacations & holidays paid and Christmas bonus*
- * Must comply with minimum established requirements to qualify.
Apply to be a Project Engineer today!
Recruiter: Lilly Abouomar 9395454792
Why Kelly Engineering?Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the worlds most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, were here to guide you to the next step in your engineering career.
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