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
*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.