Senior Quality Engineer

Kelly Services; Arroyo (PR); On-site; USD 39,000 - 52,000; Full time

Job summary

Kelly Services is seeking a Senior Quality Engineer for a top client in Arroyo, PR. The role focuses on identifying failure modes, QA practices, and risk management across NPD and transfers.

The position requires extensive collaboration, strong knowledge of FDA-QSR/ISO validation, and bilingual English/Spanish capabilities, with an 18-month contract and a pay rate of $33 per hour W2.

Qualifications

• Excellent interpersonal communication, collaborative teamwork, 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).

Responsibilities

• Evaluate process risks, implement controls throughout the manufacturing lifecycle.
• Implement internal detective process controls.
• Specify preventative and detective controls and communicate to vendors/clients.
• Verify gage repeatability, reproducibility, and address deficiencies in inspection methods.
• Support development of inspection methods and validate them; ensure supplier methods correlate.
• Ensure worst-case scenarios are tested during development/validation.
• Identify new suppliers and supplier development activities for continuity.
• Lead supplier component qualifications through PPAP and ensure controls at suppliers.
• Collaborate with Staff Engineer on process validation to ensure repeatable processes.
• Develop a validation strategy and statistical rationale; determine sample size, duration, and runs; challenge worst-case scenarios.
• Eliminate waste from processes; execute performance qualification activities for new process.
• Develop sterilization validation strategies and document such activities.
• Maintain compliance with quality regulations; support audits; train others in QA/GMP topics.
• Prepare for transition by training quality assurance engineers and inspectors.
• Lead quality activities during Post Launch Monitoring: measure KPIs, report performance, stop non-conforming, lead CAPA.

Skills

Interpersonal communication

Teamwork

Negotiation

Blueprint reading

Inspection techniques

PC skills

Financial knowledge

Written/oral communication

Hand tools

Troubleshooting

Validation (FDA-QSR/ISO)

Statistics basics

DOE

Hypothesis testing

Data interpretation

Technical writing

Presentation skills

Sterile packaging knowledge

Sterilization methods knowledge

Bilingual English/Spanish

Job description

Kelly Services is currently seeking a Senior Quality Engineer for one of our top clients in Arroyo, PR.

Job Description

JOB TITLE: Senior Quality Engineer

LOCATION: Arroyo, PR

DURATION: 18 Months (Temporary / Contract)

PAY RATE: $33 per hour W2

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).
• Implement internal detective process controls.
• Specify which preventative and detective controls are required, and communicate to vendors, internal/ external clients.
• Verify gage repeatability, reproducibility, and accuracy, and address deficiencies on inspection methods
• Support the development of inspection methods.
• Validate inspection methods and ensure methods between supplier and correlate accordingly.
• 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.
• Develop a validation strategy.
• Develop statistical rationale for testing.
• Develop the rationale for validation sample size, duration, and number of runs.
• Ensure worst-case scenarios are challenged during the process development and/or validation.
• Eliminate waste from the processes (i.e. scrap, rework, wait times, etc).
• 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:
  • Continuously fully comply with all quality regulatory requirements.
  • May support internal and external audits.
  • Commit to environmental policy.
  • 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
  • Measure, Analyze and report key process indicators.
  • Develop the quality report and communicate product/process performance to the Operation Unit assigned for new products.
  • Stop further processing in the event of encountering non-conforming product condition.
  • Lead investigation and on-time closure of non-conformances, corrective & preventive actions internally and at suppliers.

Advanced Responsibilities

• Has some latitude for unrelieved action or decisions.
• Works with minimum supervision, conferring with superiors on unusual matters.
• 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.
• 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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