Engr 3, Quality

Responsibilities

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• Quality System Management:
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  • Provide engineering support to maintain a comprehensive quality management system, tailored to the distribution of medical devices and pharmaceuticals.
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  • Ensure systems are in line with Good Distribution Practices, ISO13485 and other relevant regulatory standards.
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  • Provide statistical data analysis in support of investigations and continuous improvement projects.
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  • Lead or participate in qualifying suppliers within calibration, validation or temperature monitoring processes.
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• Quality Operations Oversight:
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  • Monitor quality control processes in change control, temperature monitoring and validations including implementing continuous improvement strategies.
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• Validation and Calibration Expertise:
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  • Lead validation efforts for distribution equipment, processes, and software, ensuring accuracy and reliability, including IQ/OQ/PQ protocol writing, execution and approval of protocols.
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  • Oversee the calibration of critical instrumentation to maintain precise measurements and controls, including OOT investigations
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  • Manage validation vendors to ensure on time calibrations, at multiple sites, of all critical equipment.
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• Environmental Monitoring:
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  • Monitor Environmental conditions at Distribution Centers to protect product integrity.
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  • Implement and manage controls for temperature, humidity, and other critical parameters.
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  • Implement and manage shipping lane controls to ensure product integrity is safeguarded throughout the shipping process.
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• Audit and Compliance Readiness:
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  • Prepare for and support both internal and external audits.
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  • Address audit outcomes swiftly and effectively to maintain compliance.
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• Quality Incident Investigation:
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  • Spearhead investigations into any quality deviations, non-conformances, or customer complaints.
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  • Implement corrective actions to prevent recurrence and enhance quality.
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  • Directly participate in quality investigations, including owning those investigations to closure.
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  • Act as a reviewer and approver of quality investigations
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• Document and Change Management:
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  • Maintain controlled procedures within calibration, validation, environmental controls, change control and risk management.
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  • Ensure data from environmental controls is maintained in centralized repository.
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  • Manage change control processes to ensure seamless transitions and compliance.
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  • Lead change control process for designated sites.
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Required Qualifications:

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• Bachelor’s degree in engineering
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• 2-3 years of experience in quality engineering, within a distribution center or manufacturing of medical devices or pharmaceuticals.
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Preferred Qualifications:

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• Master’s degree in engineering
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• ASQ CQA or CQE certification
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• Experience with Boards of Pharmacy, licensing, and regulatory submissions
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• Experience as a designated representative with state boards of pharmacy
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• 2-3 years’ experience with ISO 13485, certification preferred
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Skills:

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