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
Applicant Notices & Disclaimers
For information on benefits, equal opportunity employment, and location-specific applicant notices, click here
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.This position's pay range is $41.88/hr - $46.00/hr.
