Manager, Quality Control

Centinel Spine®, LLC is the leading global medical device company exclusively focused on addressing cervical and lumbar spinal disease with pro disc ®, the most complete total disc replacement (TDR) technology platform in the world. The Company's pro disc ® technology is the most studied and clinically proven TDR system across the globe, validated by over 540 published papers and more than 300,000 implantations. Centinel Spine's pro disc ® is the only TDR technology with multiple motion-preserving anatomic solutions, allowing the surgeon to Match-the-Disc™ to each patient's anatomy for both cervical and lumbar total disc replacement.

About the opportunity:

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. Where you will make an impact: 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.

What you will bring:

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.

Where you will go:

This position is 100% on-site at our West Chester, PA Corporate office.

What we offer:

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. This is an excellent opportunity to work for a growing, team-orientated company passionate about making a difference and improving patient lives.

Note:

The above job description describes the general nature and level of work being performed by employees assigned to this position. It is not intended to be construed as an all-inclusive list of all responsibilities, duties and skills required of all employees assigned to this position. Duties, responsibilities, and activities may change at any time with or without notice. Centinel Spine is proud to be an equal opportunity employer.