Job Description
Job Description
Responsibilities
- 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.
- Environmental Monitoring:
- 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:
- Bachelor’s degree in engineering
- 2-3 years of experience in quality engineering, within a distribution center or manufacturing of medical devices or pharmaceuticals.
Preferred Qualifications:
- Master’s degree in engineering
- 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
Shift: ["1-3 years' experience in medical device or pharmaceutical manufacturing", '1-3 years validation experience in medical device or pharmaceutical industries']
Start: []