Job Description:
Kelly Services is currently seeking a
Senior Quality Engineer for one of our top clients
in Arroyo, PR.
JOB TITLE: Senior Quality Engineer
LOCATION: Arroyo
, PR
DURATION: 18 Months (Temporary / Contract)
PAY RATE: $33 per hour W2
JOB DESCRIPTION:
Basic Function:
• Responsible for the identification of potential failure modes and risks, and the development of quality assurance practices and controls in multiple new product developments and/or manufacturing transfers. Knows and applies the fundamental and some advanced concepts, practices and procedures of the new product introduction quality specialization.
- Support the required stages defined in the product and process design cycle ensuring compliance with the current design control and transfer regulations and policy.
Responsibilities:
- Responsible for the evaluation of process risks, risk mitigation and ensures appropriate production and process controls are identified, qualified and implemented throughout the product manufacturing lifecycle (from incoming of materials/components, manufacturing, until product release).
o Implement internal detective process controls.
o Specify which preventative and detective controls are required, and communicate to vendors, internal/ external clients.
o Verify gage repeatability, reproducibility, and accuracy, and address deficiencies on inspection methods
o Support the development of inspection methods.
o Validate inspection methods and ensure methods between supplier and correlate accordingly.
o Ensure potential process failures are reproduced and/or tested to evaluate internal and external impact.
- Support the identification of new suppliers and supplier development activities to ensure compliance and business continuity.
- Lead supplier component qualifications through Production Part Approval Process (PPAP) and ensure appropriate controls are placed at the suppliers to ensure and verify components quality.
- Collaborates with Staff Engineer in all process validation activities to ensure consistent, repeatable and effective processes are implemented during design/manufacturing transfer.
o Develop a validation strategy.
o Develop statistical rationale for testing.
o Develop the rationale for validation sample size, duration, and number of runs.
o Ensure worst-case scenarios are challenged during the process development and/or validation.
o Eliminate waste from the processes (i.e. scrap, rework, wait times, etc).
o Execute performance qualification activities for new process.
- Develops sterilization validation strategies with Subject Matter Experts and is responsible to execute and document such validation activities.
• Compliance:
o Continuously fully comply with all quality regulatory requirements.
o May support internal and external audits.
o Commit to environmental policy.
o May train others in quality assurance/GMP related topics.
- Prepare product and operations for transition, by training quality assurance engineers and inspectors and conducting knowledge transfer activities.
- Lead quality activities during Post Launch Monitoring
o Measure, Analyze and report key process indicators.
o Develop the quality report and communicate product/process performance to the Operation Unit assigned for new products.
o Stop further processing in the event of encountering non-conforming product condition.
o Lead investigation and on-time closure of non-conformances, corrective & preventive actions internally and at suppliers.
• Advanced Responsibilities
o Has some latitude for unrelieved action or decisions.
o Works with minimum supervision, conferring with superiors on unusual matters.
o Viewed as a team resource in the area of expertise (i.e. Inspection Methods, Quality System, Design Transfer, Process Validations, Sterilization, PPAP, Risk
Management, Applied Statistics…) and develops/trains other engineers in this area.
o Provides coaching to Engineers, Coops and/or Contractors.
- Customer Service Orientation: Keeps customer (internal and external) needs in mind when approaching all tasks and decisions.
- Collaborative Teamwork: Works effectively with others to achieve team and organizational goals.
- Individual Influence: Influences others of the merits of own point of view and earns their support. Possesses personal credibility and inspires confidence, handles opposition constructively, and treats others with respect.
- Promotes clear communication of project quality expectations to team members, divisional contacts and suppliers.
- Engagement: Encourages, inspires, and influence others, creating a positive impact on the team, builds an engaged employee team in pursuit of the shared vision.
Required Skills:
- Excellent interpersonal communication, collaborative team work, and negotiation skills.
- Blueprint/engineering schematic reading and interpretation.
- Must be able to analyze and correct complex process and/or system issues of a broad scope using independent judgment.
- Basic inspection techniques.
- Basic PC skills.
- Financial knowledge.
- Excellent written/oral communication skills.
- Demonstrated ability to operate small hand tools (e.g. pliers, screwdrivers, hammer, wrenches, etc.), power tools and test/inspection equipment.
- Demonstrated mechanical/electrical troubleshooting and problem solving skills.
- Strong knowledge in Validation per FDA-QSR and ISO guidelines.
- Strong Statistical Knowledge: Basic concepts of parameters (mean, std. dev., capability index, Normality, etc), advanced statistics (DOE, Hypothesis testing, regressions, simulation…) graphical tools (Box-Plot, Pareto, Histogram, Surface Modeling, etc) and statistical results interpretation
- Technical writing skills.
- Effective presentation skills.
- Basic knowledge on Sterile Packaging technologies and standards
- Basic knowledge on Sterilization Methods and qualification requirements.
- Fully Bilingual (English and Spanish).
Let us help advance your career today.
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan.
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 world’s 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, we’re here to guide you to the next step in your engineering career.
About Kelly
Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year.
Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
Kelly may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice.
