Quality Assurance Engineer II

Summary The Quality Assurance Engineer is responsible for leading quality engineering activities to support the compliance of products and processes. This role will apply technical knowledge, understanding of regulatory standards, and internal processes to support continuous improvement. The Quality Assurance Engineer will be tasked with maintaining systems and processes that ensure product quality and adherence to the Quality Management System (QMS). Key responsibilities will include equipment maintenance, calibration, process validation, investigations, and continuous process improvement.

Responsibilities & Duties Equipment Maintenance and Calibration:

Oversee the maintenance, calibration, and qualification of production equipment to ensure optimal performance and compliance with quality standards. Coordinate regular calibration checks and maintenance schedules to minimize downtime and maintain product consistency.

Process Validation and Monitoring:

Works with QA and Production teams to develop and execute process and equipment validation protocols compliant with

ISO 13485, 21 CFR

820, and other relevant standards.

Investigations and Root Cause Analysis:

Lead investigations into non-conformances, deviations, and process failures, conducting root cause analysis to identify underlying issues and implement corrective actions. Work closely with cross-functional teams to resolve quality concerns and enhance processes to prevent recurrence.

Service Scheduling:

Communication with suppliers to schedule equipment maintenance and calibration activities. Review of incoming and renewed calibration certificates. Communication with Production, R&D, and Histology teams to schedule equipment servicing and calibration in alignment with production needs.

Regulatory Compliance and Documentation:

Ensure all activities comply with regulatory standards, including ISO, FDA, and other industry-specific requirements. Maintain and update documentation to support quality audits, regulatory inspections, and internal reviews, ensuring full compliance with QMS and industry standards.

Continuous Improvement:

Utilize data from quality events to lead continuous improvement activities.

QMS Support:

Support for the QMS in this role will include assignments for design control projects under direction of QA and Project Managers, risk evaluation, CAPA / quality event investigation, and resolution of minor compliance concerns. Major compliance concerns are communicated to the QA Manager for resolution.

Reporting and Data Analysis:

Compile and present quality performance data, including trend analysis, metrics, and KPIs, to management. Track and report on the effectiveness of corrective actions, process improvements, and maintenance activities.

Records Management and Compliance:

Review and organize electronic and paper records to ensure completeness, accuracy, and compliance with internal and regulatory requirements. Other duties as assigned. Skills Required Excellent organizational and time management skills, with the ability to prioritize tasks and manage multiple priorities. Attention to detail and documentation of work. Strong communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and communicate schedule changes and updates. Ability to work independently with minimal supervision and demonstrate initiative and problem solving skills.

Qualifications:

Bachelor's degree in Engineering, Science, or related field (preferred). Alternatively, an equivalent combination of relevant experience and qualifications may be considered in lieu of a degree. Minimum of 3 years of experience in quality assurance, or a related field, preferably in manufacturing or production environments with ISO 13485 and / or 21 CFR 820. Experience authoring or collaborating on validation protocols. Strong knowledge of quality management systems (QMS), regulatory standards (ISO, FDA, etc.), and process improvement methodologies (e.g., Six Sigma, Lean). Experience with equipment calibration, process validation, and root cause analysis. Proficient in data analysis, documentation, and reporting. Excellent problem-solving, analytical, and communication skills. Advanced Software skills such as Microsoft Office, ERP/MRP.

Job Type:

Full-time FLSA:

Non-Exempt Pay:

$39.82

• 46.

92 per hour

Work Location:

Must be In person/onsite

• No remote/hybrid work granted for this role.

Schedule:

8 hour shift Day shift Monday to

Friday Benefits:

Generous 401(k) matching Dental insurance with option for ortho plan Flexible schedule 85% Employer Contribution Health insurance On-the-job training Rich Paid time off Vision insurance Cross-training opportunities Compensation package: Bonus opportunities Merit based reviews Cost of living adjustments Competitive compensation Employee tuition reimbursement

Job Type:

Full-time Pay:

$39.82

• $46.

92 per hour Expected hours: 40 per week

Benefits:

401(k) matching Dental insurance Flexible schedule Health insurance Paid time off Tuition reimbursement Vision insurance

Schedule:

8 hour shift Monday to

Friday Work Location:

In person Quality Assurance Engineer II Goleta, CA 93117 $39.82

• $46.92 an hour
• Full-time $39.82
• $46.92 an hour
• Full-time Summary The Quality Assurance Engineer is responsible for leading quality engineering activities to support the compliance of products and processes.

This role will apply technical knowledge, understanding of regulatory standards, and internal processes to support continuous improvement. The Quality Assurance Engineer will be tasked with maintaining systems and processes that ensure product quality and adherence to the Quality Management System (QMS). Key responsibilities will include equipment maintenance, calibration, process validation, investigations, and continuous process improvement.

Responsibilities & Duties Equipment Maintenance and Calibration:

Oversee the maintenance, calibration, and qualification of production equipment to ensure optimal performance and compliance with quality standards. Coordinate regular calibration checks and maintenance schedules to minimize downtime and maintain product consistency.

Process Validation and Monitoring:

Works with QA and Production teams to develop and execute process and equipment validation protocols compliant with

ISO 13485, 21 CFR

820, and other relevant standards.

Investigations and Root Cause Analysis:

Lead investigations into non-conformances, deviations, and process failures, conducting root cause analysis to identify underlying issues and implement corrective actions. Work closely with cross-functional teams to resolve quality concerns and enhance processes to prevent recurrence.

Service Scheduling:

Communication with suppliers to schedule equipment maintenance and calibration activities. Review of incoming and renewed calibration certificates. Communication with Production, R D, and Histology teams to schedule equipment servicing and calibration in alignment with production needs.

Regulatory Compliance and Documentation:

Ensure all activities comply with regulatory standards, including ISO, FDA, and other industry-specific requirements. Maintain and update documentation to support quality audits, regulatory inspections, and internal reviews, ensuring full compliance with QMS and industry standards.

Continuous Improvement:

Utilize data from quality events to lead continuous improvement activities.

QMS Support:

Support for the QMS in this role will include assignments for design control projects under direction of QA and Project Managers, risk evaluation, CAPA / quality event investigation, and resolution of minor compliance concerns. Major compliance concerns are communicated to the QA Manager for resolution.

Reporting and Data Analysis:

Compile and present quality performance data, including trend analysis, metrics, and KPIs, to management. Track and report on the effectiveness of corrective actions, process improvements, and maintenance activities.

Records Management and Compliance:

Review and organize electronic and paper records to ensure completeness, accuracy, and compliance with internal and regulatory requirements. Other duties as assigned. Skills Required Excellent organizational and time management skills, with the ability to prioritize tasks and manage multiple priorities. Attention to detail and documentation of work. Strong communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and communicate schedule changes and updates. Ability to work independently with minimal supervision and demonstrate initiative and problem solving skills.

Qualifications:

Bachelor's degree in Engineering, Science, or related field (preferred). Alternatively, an equivalent combination of relevant experience and qualifications may be considered in lieu of a degree. Minimum of 3 years of experience in quality assurance, or a related field, preferably in manufacturing or production environments with ISO 13485 and / or 21 CFR 820. Experience authoring or collaborating on validation protocols. Strong knowledge of quality management systems (QMS), regulatory standards (ISO, FDA, etc.), and process improvement methodologies (e.g., Six Sigma, Lean). Experience with equipment calibration, process validation, and root cause analysis. Proficient in data analysis, documentation, and reporting. Excellent problem-solving, analytical, and communication skills. Advanced Software skills such as Microsoft Office, ERP/MRP.

Job Type:

Full-time FLSA:

Non-Exempt Pay:

$39.82

• 46.

92 per hour

Work Location:

Must be In person/onsite

• No remote/hybrid work granted for this role.

Schedule:

8 hour shift Day shift Monday to

Friday Benefits:

Generous 401(k) matching Dental insurance with option for ortho plan Flexible schedule 85% Employer Contribution Health insurance On-the-job training Rich Paid time off Vision insurance Cross-training opportunities Compensation package: Bonus opportunities Merit based reviews Cost of living adjustments Competitive compensation Employee tuition reimbursement

Job Type:

Full-time Pay:

$39.82

• $46.

92 per hour Expected hours: 40 per week

Benefits:

401(k) matching Dental insurance Flexible schedule Health insurance Paid time off Tuition reimbursement Vision insurance

Schedule:

8 hour shift Monday to

Friday Work Location:

In person