Quality Engineer 3

Sunrise Systems, Inc.; Covington (GA); On-site; USD 65,000 - 90,000; Full time

Job summary

Sunrise Systems, Inc. is seeking a Quality Engineer for medical device/pharma distribution environments. You will support the quality management system, engage in validation and calibration activities, and ensure compliance with regulatory standards across sites.

The role requires 2–3 years of quality engineering experience, familiarity with ISO 13485 and FDA regulations, and the ability to manage change controls and audits. On-site role based in Covington, GA.

Qualifications

• 2–3 years of quality engineering in medical devices or pharmaceutical distribution/manufacturing.
• ASQ CQA or CQE certification preferred.
• Experience with ISO 13485 and FDA regulations preferred.
• Experience with regulatory submissions and state boards.

Responsibilities

• Support quality management system per GDP, ISO13485 standards.
• Lead validation and calibration for distribution equipment and processes.
• Oversee change control and environmental monitoring at multiple sites.
• Prepare for internal and external audits; address findings.
• Investigate quality deviations and implement corrective actions.
• Ensure documentation control across calibration and risk management.

Skills

Problem solving

ERP systems

FDA/ISO knowledge

Quality engineering

Regulatory submissions

Education

ASQ CQA or CQE

Job description

1-3 years' experience in medical device or pharmaceutical manufacturing

1-3 years validation experience in medical device or pharmaceutical industries

Quality System Management:

• Provide engineering support to maintain a comprehensive quality management system, tailored to the distribution of medical devices and pharmaceuticals.
• Ensure systems are in line with Good Distribution Practices, ISO13485 and other relevant regulatory standards.
• Provide statistical data analysis in support of investigations and continuous improvement projects.
• Lead or participate in qualifying suppliers within calibration, validation or temperature monitoring processes.

Quality Operations Oversight:

• Monitor quality control processes in change control, temperature monitoring and validations including implementing continuous improvement strategies.
• Validation and Calibration Expertise:
• Lead validation efforts for distribution equipment, processes, and software, ensuring accuracy and reliability, including IQ/OQ/PQ protocol writing, execution and approval of protocols.
• Oversee the calibration of critical instrumentation to maintain precise measurements and controls, including OOT investigations
• Manage validation vendors to ensure on time calibrations, at multiple sites, of all critical equipment.
• Monitor Environmental conditions at Distribution Centers to protect product integrity.
• Implement and manage controls for temperature, humidity, and other critical parameters.
• Implement and manage shipping lane controls to ensure product integrity is safeguarded throughout the shipping process.

Audit and Compliance Readiness:

• Prepare for and support both internal and external audits.
• Address audit outcomes swiftly and effectively to maintain compliance.

Quality Incident Investigation:

• Spearhead investigations into any quality deviations, non-conformances, or customer complaints.
• Implement corrective actions to prevent recurrence and enhance quality.
• Directly participate in quality investigations, including owning those investigations to closure.
• Act as a reviewer and approver of quality investigations

Document and Change Management:

• Maintain controlled procedures within calibration, validation, environmental controls, change control and risk management.
• Ensure data from environmental controls is maintained in centralized repository.
• Manage change control processes to ensure seamless transitions and compliance.
• Lead change control process for designated sites.

Required Qualifications:

• 2-3 years of experience in quality engineering, within a distribution center or manufacturing of medical devices or pharmaceuticals.

Preferred Qualifications:

• ASQ CQA or CQE certification
• Experience with Boards of Pharmacy, licensing, and regulatory submissions
• Experience as a designated representative with state boards of pharmacy
• 2-3 years' experience with ISO 13485, certification preferred

Skills:

• Excellent problem-solving skills with the ability to think critically and creatively.
• Experience working with ERP systems.
• Knowledge of FDA regulations and ISO standards related to medical device manufacturing.
• 2- 3 years' experience with ISO 13485, certification preferred