Senior Quality Engineer

1 week ago

Gilbert, United States Solü Technology Partners Full time

Local Candidates only please Position will require onsite

No 3rd Parties

With a commitment to innovation and its employees, our partner has won numerous awards for not only the product they offer, but the work-life environment they have created. They were named on Top Workplaces list three years in a row and have been recognized over 10 times for their product quality and innovation.

Job summary:

Holds a role in ensuring the seamless integration of quality assurance processes across the organization. The scope of the QE's responsibilities encompasses:

Integration Activities:

  • Collaborate with cross-functional teams to seamlessly integrate quality assurance processes across various stages of the quality system.
  • Facilitate communication and coordination between quality assurance and other departments/sites to foster a culture of quality excellence.

KPI Definition/Establishment:

  • Assess, define, and establish Key Performance Indicators (KPIs) to effectively measure the efficiency and effectiveness of quality assurance processes.
  • Develop and implement strategies aimed at enhancing KPI performance and driving continuous improvement in quality outcomes.

Trending:

  • Establish a robust system to monitor and analyze trends in quality data, encompassing defect rates, customer complaints, and non-conformance incidents.
  • Utilize data analysis to identify patterns and potential areas for improvement, enabling proactive measures to address quality concerns.

Validation:

  • Define and refine the validation process, ensuring alignment with regulatory requirements and industry best practices.
  • Develop comprehensive validation protocols, execute testing, and meticulously document results in accordance with established procedures, if necessary.

Change Control:

  • Evaluate and refine the change control system, meticulously assessing potential impacts on product quality and regulatory compliance.
  • Implement necessary modifications to ensure a controlled change management process that minimizes risks and maintains quality standards.

Sampling Regimes Assessment:

  • Conduct a thorough evaluation of existing sampling regimes, ensuring their suitability and effectiveness in upholding product quality and regulatory compliance.
  • Recommend adjustments or enhancements to sampling plans based on meticulous data analysis and comprehensive risk assessment.

Project Support

  • Actively participate and assist in the planning of the Validation Strategic development for new Processes (NP) / New Technology (NT)
  • Provide the appropriate quality technical support to new product development and improvement projects.
  • Responsible of Sampling Plan Preparation, Quality Plan Development, Test procedures Implementation and Statistical Data Analysis.
  • Use of quality/statistical tools for troubleshooting and process improvement
  • Evaluate process/technology changes potential impact on the business and recommending their incorporation into the current and future product lines.
  • Lead quality initiatives and participate in multi-disciplinary teams engaged on above activities.
  • Validation activities such as: Protocols, Execution, Deviations, and Reports

Knowledge Required:

  • Knowledge of FDA current GMP/QSR Regulation
  • Strong applied knowledge on statistical tools: DOE, Acceptance Sampling, SPC, etc.
  • Supervisory skills
  • Good oral and written communication skills in both English and Spanish are a must
  • Highly motivated, self-starter, and responsible person
  • Teamwork oriented

Qualifications:

  • Five years or more of experience in Quality Engineering
  • Willing to travel
  • Bachelor degree in Engineering, Science or related field
  • Experience in Medical Device industry

*Sol Technology Partners provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, national origin, age, disability or genetics.

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