Quality Assurance Engineer - Two Open Positions

Centinel Spine®, LLC is the leading global medical device company exclusively focused on addressing cervical and lumbar spinal disease with prodisc®, the most complete total disc replacement (TDR) technology platform in the world.

The Company’s prodisc® 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 prodisc® 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 looking for two (2)  Quality Assurance Engineers, to support the Quality Management System (QMS) through complaint handling, CAPA coordination, regulatory reporting, internal audits, and cross-functional quality initiatives. The Quality Assurance Engineers must be able to work onsite 3 to 4 days per week in the West Chester, PA office. The role reports to the Quality Assurance Manager.

Where you will make an impact:

1. • Intake, investigate, and document product complaints; maintain complaint logs and support trending, closure and follow up.
   • Ensure compliance with applicable regulations, standards, and the company’s QMS.
   • Prepare and submit Medical Device Reports, Vigilance Reports, and other adverse event reports to authorities.
   • Coordinate CAPA activities, including status updates to management, training team members, and organizing root cause analysis and corrective/preventive actions.
   • Analyze QMS data and prepare monthly metrics (complaints, CAPAs, NCMRs, field returns, vendor scorecards, document control, training).
   • Perform Quality review of surgeon training records, verifying appropriate documentation and compliance to procedure.
   • Represent Quality on product development teams to ensure regulatory compliance and contribute to QMS documentation.
   • Perform root cause analyses, corrective and preventive actions for completion of CAPA documentation.
   • Assist in drafting and updating QMS documentation.
   • Assist with documenting recalls or field safety corrective actions.
   • Review and approve QMS document changes as Quality Assurance representative and maintain controlled document files.
   • Support development and maintenance of FMEAs and risk assessments with cross-functional teams.
   • Participate in internal, notified body, and FDA audits.
   • Assist in developing and delivering quality training.
   • Support regulatory activities, including providing documentation to distributors and regulators.
   • Perform other Quality Assurance duties as assigned.
     
     

What you will bring:

1. • Bachelor in Engineering or Science degree (or equivalent experience) required.
   • 2–3 years of experience in Quality Assurance in a regulated environment (ISO 13485 / MDD / MDR / MDSAP).
   • Experience in complaint handling and CAPA investigations preferred.
   • Proficiency in Microsoft Word and Excel.
   • Experience analyzing data using pivot charts and tables preferred.
   • Experience with electronic QMS tools (e.g., MasterControl) preferred.
   • Strong self-starter with excellent communication skills.

Where you will go:

• The Quality Assurance Engineer will work onsite 3 to 4 days per week in the West Chester, PA office. This position is not eligible for relocation assistance. 

What we offer:

• We offer a competitive compensation package with an annual bonus incentive. 
• We offer a comprehensive healthcare benefits program that includes medical, dental, vision, life insurance and disability coverage along with the several voluntary benefit programs for work/life needs, effective on the first day of employment.
• We also offer 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, 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.