Quality Assurance Analyst
San Diego, CA
Full Time
Mid Level
Quality Assurance Analyst Job Description
Position Overview
The Quality Assurance Analyst will oversee key components of the Quality System, focusing on supplier oversight, corrective actions, customer feedback, regulatory compliance, and product release processes.
Key Responsibilities
- Conduct audits of suppliers as needed to ensure quality standards are met.
- Develop, review, and validate standard operating procedures (SOPs), testing protocols, and compliance documentation to ensure adherence to regulatory requirements and internal guidelines.
- Manage quality-related activities, including addressing deviations, non-conformities, and customer feedback.
- Lead investigations for corrective and preventive actions (CAPAs).
- Assess and document the impact of deviations and customer complaints on product quality.
- Review and approve risk analyses related to engineering changes and recalls.
- Oversee engineering change orders and maintain accurate documentation; collaborate with various teams to resolve quality-related issues.
- Collaborate with manufacturing teams to integrate risk management practices and ensure compliance throughout the product development lifecycle.
- Engage in both internal and external compliance audits.
- Provide ongoing support and training to quality assurance team members.
- Contribute to the development of training initiatives aimed at enhancing product quality.
- Analyze quality metrics and trends for continuous improvement.
Additional Responsibilities
- Plan and prioritize projects aligned with organizational goals.
- Work with product development teams to ensure adherence to regulatory standards.
- Perform additional tasks as assigned by management.
Education and Experience
- Bachelor’s degree in a relevant scientific field or equivalent experience; an engineering degree is preferred.
- Minimum of 5 years in quality assurance, preferably within the biotech or medical device sectors, with experience in a regulated environment.
Required Skills
- Strong understanding of quality assurance processes related to medical products, including testing protocols and statistical methodologies.
- High integrity and professionalism with a strong work ethic and the ability to work autonomously.
- Exceptional communication and presentation abilities.
- Proactive and results-oriented with a strong sense of urgency.
- Capable of initiating and managing change effectively.
- Detail-oriented with a high degree of accuracy in data management.
- Proficient in gathering and analyzing information to resolve issues.
Core Competencies
- Performance-Driven: Committed to achieving departmental objectives and comfortable with measurable outcomes.
- Impact-Focused: Aims to contribute meaningfully to organizational goals and positively affect user experiences.
- Competitive Spirit: Motivated to excel within the industry and support the organization's growth ambitions.
- Urgency: Demonstrates agility and responsiveness to company goals.
- Resilience: Maintains composure under pressure and navigates ambiguity effectively.
- Confidence: Exhibits assurance in skills and pursues tasks with determination.
- Multitasking Ability: Capable of managing multiple priorities efficiently.
Position Overview
The Quality Assurance Analyst will oversee key components of the Quality System, focusing on supplier oversight, corrective actions, customer feedback, regulatory compliance, and product release processes.
Key Responsibilities
- Conduct audits of suppliers as needed to ensure quality standards are met.
- Develop, review, and validate standard operating procedures (SOPs), testing protocols, and compliance documentation to ensure adherence to regulatory requirements and internal guidelines.
- Manage quality-related activities, including addressing deviations, non-conformities, and customer feedback.
- Lead investigations for corrective and preventive actions (CAPAs).
- Assess and document the impact of deviations and customer complaints on product quality.
- Review and approve risk analyses related to engineering changes and recalls.
- Oversee engineering change orders and maintain accurate documentation; collaborate with various teams to resolve quality-related issues.
- Collaborate with manufacturing teams to integrate risk management practices and ensure compliance throughout the product development lifecycle.
- Engage in both internal and external compliance audits.
- Provide ongoing support and training to quality assurance team members.
- Contribute to the development of training initiatives aimed at enhancing product quality.
- Analyze quality metrics and trends for continuous improvement.
Additional Responsibilities
- Plan and prioritize projects aligned with organizational goals.
- Work with product development teams to ensure adherence to regulatory standards.
- Perform additional tasks as assigned by management.
Education and Experience
- Bachelor’s degree in a relevant scientific field or equivalent experience; an engineering degree is preferred.
- Minimum of 5 years in quality assurance, preferably within the biotech or medical device sectors, with experience in a regulated environment.
Required Skills
- Strong understanding of quality assurance processes related to medical products, including testing protocols and statistical methodologies.
- High integrity and professionalism with a strong work ethic and the ability to work autonomously.
- Exceptional communication and presentation abilities.
- Proactive and results-oriented with a strong sense of urgency.
- Capable of initiating and managing change effectively.
- Detail-oriented with a high degree of accuracy in data management.
- Proficient in gathering and analyzing information to resolve issues.
Core Competencies
- Performance-Driven: Committed to achieving departmental objectives and comfortable with measurable outcomes.
- Impact-Focused: Aims to contribute meaningfully to organizational goals and positively affect user experiences.
- Competitive Spirit: Motivated to excel within the industry and support the organization's growth ambitions.
- Urgency: Demonstrates agility and responsiveness to company goals.
- Resilience: Maintains composure under pressure and navigates ambiguity effectively.
- Confidence: Exhibits assurance in skills and pursues tasks with determination.
- Multitasking Ability: Capable of managing multiple priorities efficiently.
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