Senior Quality Engineer

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).

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