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.
Note: Will require some onsite locally in Gilbert, AZ
NO THIRD PARTIES PLEASE!
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:
Essential Functions & Accountabilities
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
Skills 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
*Solü 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.
