Quality Assurance Engineer - Two Open Positions

Centinel Spine, LLC • West Chester, PA

9d • Hybrid

About The Position

Centinel Spine®, LLC is seeking two (2) Quality Assurance Engineers to support the Quality Management System (QMS). This role involves 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.

Requirements

• 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).
• Proficiency in Microsoft Word and Excel.

Nice To Haves

• Experience in complaint handling and CAPA investigations preferred.
• 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.

Responsibilities

• 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.

Benefits

• Competitive compensation package with an annual bonus incentive.
• Comprehensive healthcare benefits program that includes medical, dental, vision, life insurance and disability coverage.
• Several voluntary benefit programs for work/life needs, effective on the first day of employment.
• Generous paid time off.
• Company paid holiday programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level