Manager, Quality Control

Centinel Spine, LLC • West Chester, PA

15d • Onsite

About The Position

If you are passionate about making a difference, we are seeking Manager, Quality Control (QC) to oversee all QC inspections, lead the inspection team, and maintain a compliant and proactive quality system, drive continuous improvement, and directly impact patient safety and product reliability. This position reports to the Vice President, Clinical, Regulatory and Quality Affairs and is located 100% onsite in West Chester, PA.

Requirements

• Bachelor’s degree in engineering, science, or a related technical field. Advanced degree or professional certification (ASQ CQE, CQM/OE) is highly preferred.
• 5+ years of quality control or assurance experience within medical device manufacturing, with specific experience in 510(k) and PMA domains.
• 2+ years of demonstrated success in a supervisory or management role.
• Deep understanding of FDA QSR (21 CFR 820), ISO 13485, ISO 14971, and GMP principles.
• Expertise in QC inspection techniques, statistical analysis (SPC, capability studies, MSA), and proficiency with electronic QMS, ERP, and DHR systems.
• Excellent leadership, communication, and coaching abilities, with the ability to influence cross-functionally and manage multiple priorities.
• Ability to sit and stand for extended periods and lift objects up to 25 lbs.

Nice To Haves

• Advanced degree or professional certification (ASQ CQE, CQM/OE) is highly preferred.

Responsibilities

• Spearhead the professional growth of the Quality Control team structured mentorship and continuous learning initiatives.
• Develop and implement quality control processes and procedures.
• Collaborate with other departments to resolve quality-related matters.
• Ensure compliance with regulatory standards and industry best practices.
• Establish KPIs, conduct rigorous performance reviews, and optimize staffing workflows to align with production schedules.
• Champion a culture of accountability and precision, ensuring the team remains focused on high-quality outcomes and safety.
• Oversee the end-to-end inspection of incoming, in-process, and finished devices, ensuring 100% adherence to sampling plans and test methods.
• Review and approve Device History Records (DHRs) and technical documentation to ensure audit readiness and product safety.
• Manage timely product release to meet shipment schedules while maintaining strict regulatory compliance.
• Guarantee full compliance with FDA 21 CFR Part 820 and ISO 13485 across all QC operations.
• Serve as a primary subject matter expert during internal and external audits (e.g., FDA, Notified Body, and supplier audits).
• Manage the calibration and maintenance of QC equipment to ensure measurement accuracy and system reliability.
• Lead cross-functional investigations with Engineering and Manufacturing to resolve complex nonconformances.
• Drive the development and implementation of Corrective and Preventive Actions (CAPA) to eliminate recurring quality issues.
• Oversee the execution of containment, rework, or scrap procedures per established quality protocols.

Benefits

• A competitive annual base salary with an annual bonus.
• A comprehensive healthcare benefits program that includes medical, dental, vision, life insurance, disability coverage, and several voluntary benefit programs.
• A generous paid time off and company paid holiday programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 11-50 employees