Kelly® Engineering is seeking Staff Quality Engineer for contract position at manufacturing client in Arroyo, Puerto Rico.  If you’re passionate about bringing the latest professional discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring.
Basic Function:
• Quality Lead in new product(s) or project(s) that have a higher level of complexity as they may include new product platforms, new technologies or product classifications.
• Responsible for the identification of potential failure modes and risks, and the development of quality assurance practices/systems and controls in multiple new product developments and/or manufacturing transfers.
• Knows and applies the advanced concepts, practices and procedures of the new product introduction quality specialization.
• Support or leads 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 Customer 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. repeatable
• Collaborates with Staff Engineer or equivalent in all process validation activities to ensure consistent, and effective design/manufacturing transfer.
o Develop a validation strategy. processes are implemented during
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 Subject Matter Expert in at least one or two of the following areas such as (i.e. Inspection Methods, Quality System, Design Transfer, Process Validations, Sterilization, Risk Management, PPAP, Applied Statistics, GD&T, …).
o Develops/trains other engineers in this area(s) within GQO and/or Division.
o Provides mentorship and coaching to Engineers, Quality Engineers, Coops and/or Contractors. o Leads projects within AO and/or GQO initiatives. o Participates in Divisional or Corporate initiatives.
• Customer Service Orientation: Keeps customer (internal and external) needs in mind when approaching all tasks and decisions. Networks with senior internal or external personnel in own areas of expertise and promotes GQO capabilities to increase new product pipeline.
• 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.
• 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 Experience:
• 7 years minimum in Quality Assurance or related functional area such as Design Transfer/Manufacturing Transfer; preferably in medical device, or other regulated industry.
• Knowledge of inspection methods in the design and production of electro-mechanical and/or mechanical equipment.
• Possess attention to detail
• Eagerness to assist internal and external customers
• Manages or supports multiple projects in a timely manner
• Ability to conduct and document technical investigation

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