Summary

The primary responsibilities of this position are to oversee the production process, maintain quality standards, and contribute to continuous improvement efforts. This involves the maintenance of all documentation regarding RUO, ASR and CE mark certifications. This role supports the ongoing efforts of the laboratory operations to standardize workflows and processes to ensure the production of quality products. 

Essential Functions

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Develops and Implement methods to inspect, test, and evaluate products and production equipment and ensure that products adhere to quality standards.
• Manages the QA/QE/QC team’s tasks and assignments.
• Oversees and maintains the system to evaluate the level of GMP compliance for manufactured products.
• Collaborate with R&D leaders and design quality team to ensure quality planning during transfer to manufacturing.
• Manage the complaint investigations, non-conformance and CAPA programs collaborating with General Manager.
• Collect data and provide trending on KPIs or Quality Objectives related to Quality Operations to upper management on regular basis. Participate and provide input to Management reviews and other upper management meetings
• Notifies senior management of potential quality issues that might impact product quality.
• Facilitates risk management and hazard analysis discussions and other reliability assessments and drive updates.
• Manages internal/external audits or inspections to ensure compliance with subject regulations.
• Works cross functionally to plan, track, implement, and monitor remediation activities related to design, manufacturing and QC resulting from audits or inspections
• Identifies quality improvement opportunities, compliance concerns, identify, prevent, and resolve deviations.
• Ensures accurate maintenance of the calibrated equipment program.
• Ensures accurate maintenance of the calibrated equipment program.
• Other duties as assigned by Management.

Competencies

• Bachelor’s degree required. Extensive experience will be considered in lieu of a BS degree.
• 1-3 years of related experience.
• Excellent communication, organizational and time management skills required.
• Ability to maintain professionalism, service-oriented demeanor.
• Excellent interpersonal skills.
• Must have the ability to multi-task, prioritize and work efficiently.
• Ability and willingness to work a flexible schedule including some early mornings, evenings and weekend days.

Expected Location & Hours of Work

• This is a full-time on-site position.
• 8 a.m. to 5 p.m. Monday – Friday. This position may require working extended weekday or weekend hours depending on business needs.

Compensation Range

• $75,000 - $100,000 annually