Our Client, a leading provider of analytical equipment and services, is currently seeking candidates for a full-time Director of Quality. This individual will be responsible for ensuring the quality management system is established, implemented, and maintained in accordance with relevant regulatory and corporate standards. Our ideal candidate is someone who can implement, foster, and lead a culture of Total Quality Management that supports current business priorities and enables continued company growth.
Located just East of Downtown Pittsburgh, this company offers a generous salary and benefits package, excellent growth potential and stability, and the opportunity to work with cutting-edge proprietary technology.
Responsibilities
- Ensure that the Quality Management System is established, implemented, and maintained in compliance with all relevant regulatory standards
- Aligns the Quality Management System to support current business priorities and improves upon it when needed
- Report and communicate to management on the performance of the quality management system and any needed improvements or quality issues
- Measure, track, and report on quality objectives
- Resolve any deficiencies in the quality management system and implement a culture of continual improvement
- Ensure the promotion of awareness of customer quality requirements throughout the organization
- Represent the company on all matters related to quality, and host external regulatory and third-party audits
- Manage a comprehensive internal auditing program and ensure that internal audits are performed no less than annually by an independent source
- Prepare responses and corrective actions to external/internal audits as necessary
- Manage and/or ensure the specified requirements of the following systems/areas are met: document control, external provider control, record control, calibration, corrective and preventative actions (CAPAs), change control, customers complaints, customer feedback, internal auditing, logbook/notebook control, validation protocol, chemical inventory, training, proficiency testing, equipment control, reference standard/reference material control, data review and reporting, disaster recovery, and safety
- Manage and monitor the corrective and preventative action programs and customer complaint system
Qualifications
- Bachelor's degree in science or an engineering-related field; Master's degree preferred
- Minimum of 10 years of relevant quality experience with 7+ years of leadership experience.
- Must have experience working with medical devices and the operating software
- Experience with leading FDA and other agency regulatory inspections a plus
- Expertise in quality principles and practices
- Well versed with 21 CFR 820, cGMP, ISO , ISO , IEC 62304, ISO 14971, MDSAP, CMDCAS, EU MDD/MDR, and other global medical device regulations
- Experienced in transforming and improving Quality processes, systems and culture with a demonstrated track record of process and productivity improvement and successful results with developing and implementing change initiatives
- provided by Dice