IntePros · 15 hours ago
Quality Control Supervisor
Conshohocken, PA
Full-time
Onsite
Mid, Senior Level
3+ years expIntePros is currently looking for a Quality Control Supervisor to join one of their growing medical device clients. The Quality Control Supervisor leads the quality inspection team and coordinates quality control processes to ensure the safety and quality of products.
ConsultingInformation TechnologyStaffing Agency
No H1B
Security Clearance Required
Responsibilities
Author and revise procedures/controlled documents according to FDA, AATB, and other applicable regulations
Support development of validation/qualification protocols and summary reports in accordance with regulatory requirements and industry best practices
Assures adequate sampling plans and inspection procedures are implemented
Maintains quality indicators and respective reports/ presentations
Assist with deviations, nonconformances, complaints, CAPAs, SCARs, and safety incidents and ensure timely completion of associated investigations
Oversee incoming inspection of HCT/Ps and medical devices in accordance with standard operating procedures and regulatory/accrediting agency requirements
Sort and segregate acceptable and unacceptable HCT/P products and/or medical devices
Manage and oversee review of quality control records to include equipment cleaning, maintenance, environmental monitoring, and supply inspections
Assist with training of processes and corrective actions relating to quality
Oversee the product release to ensure that safe and effective product is distributed to customers
Responsible for approval or rejection of components, finished products, and documents to achieve this purpose
Directs the activities of the Quality Control team
Owner of process controls and non-conforming product
Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO Standards, cGMP/CGTP, other relevant regulations/standards, and internal organizational policies and standard operating procedures
Manage direct reports
Provide constructive feedback and guidance to develop leadership in direct reports and department management
Establish and monitor objective annual goals for direct reports
Conduct performance reviews and establish performance improvement plans as needed
Recruit, interview, and select personnel for hire
Maintain acceptable attendance and punctuality for scheduled work hours and meetings
Ensure completion of assigned tasks and responsibilities within defined timeframes
Flexibility to work outside of normal business hours during weekdays or weekends with reasonable advance notice to support business/operational needs when necessary
Perform other duties as assigned
Qualification
Required
A minimum of a bachelor's degree in science, engineering, other relevant discipline; minimum of 3 years' experience working in an FDA or ISO regulated environment; or equivalent combination of education and experience
A minimum of 3 years of supervisory experience or equivalent
Clearance of favorable background investigation required
Ability to analyze information and act on results
Ability to work well with people at all levels within the organization
Accuracy and attention to detail
Ability to secure and maintain a favorable background investigation and clearance
Company
IntePros
IntePros is an established, woman-owned, privately-held technology and business services consulting agency committed to building long-term relationships and helping more companies leverage the power of a more diverse workforce.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Loren Kovalcik
CEO
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