Quality Specialist (Pittsburgh, PA)

Smith & Nephew•Pittsburgh, PA

9h•Hybrid

About The Position

Quality Specialist (Pittsburgh, PA) Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. The Quality Support Technician is responsible for duties governed by the Robotics’ Quality Management System. The Quality Support Technician will review Quality Management System Records to ensure compliance with procedures and GDP requirements. These records include but are not limited to Design History Records, and Service, Complaint and CAPA Records. The Quality Support Technician will act as a liaison between Robotics and our Contract Manufacturers and Service Team(s). What will you be doing?

Requirements

Associate or bachelor’s degree preferred.
Experience in an ISO 13485–regulated environment or other regulated industry.
Experience in manufacturing environments involving DHR creation or review.
Working knowledge of Quality Management Systems.
Strong attention to detail and ability to review large volumes of data for quality.
Effective communication and collaboration under time‑sensitive conditions.
Ability to think critically, propose solutions, and uphold quality and regulatory standards.
Proficiency with Microsoft Office applications.
Forward‑thinking problem‑solving mindset
Strong attention to detail and ability to review large volumes of data for quality.
Effective communication and collaboration under time‑sensitive conditions.
Ability to think critically, propose solutions, and uphold quality and regulatory standards.
Proficiency with Microsoft Office applications.
Forward‑thinking problem‑solving mindset

Responsibilities

Product Release Provide technical and quality oversight for Purchased Finished Goods (PFG) to maintain regulatory and QMS compliance.
Review and ensure completeness of Device History Records (DHRs) prior to product release.
Act as liaison between Contract Manufacturers and the Legal Manufacturer for release activities.
Coordinate Certificates of Conformance (CoCs) and ensure readiness of documentation for audits.
Escalate Nonconformances (NCs), CAPAs, and Supplier Change Notifications (SCNs) to Quality Engineering.
Ensure timely completion of all QMS deliverables associated with product release.
Product Installation Oversee consistency and documentation quality of Robotics System installations at customer sites.
Review and approve installation records for completeness and compliance with procedures.
Support Field Service and Quality teams in resolving installation‑related issues.
Ensure proper documentation, record retention, and escalation of recurring field issues identified during deployment.
Complaint Triage Serve as the central point of contact for all complaint‑related quality and technical support requests escalated for engineering team from investigation.
Coordinate with global investigation teams to ensure timely, complete, and consistent complaint evaluations.
Engage appropriate subject matter experts (SMEs), including Software teams, to support investigation activities.
Track, trend, and escalate recurring or software‑related field issues.
Ensure investigation quality and adherence to internal procedures and regulatory expectations.
CAPA Support Support the CAPA program by ensuring robust investigations, well-defined corrective and preventive actions, and verification of effectiveness (VOE).
Ensure CAPA processes align with regulatory requirements and corporate procedures.
Contribute to CAPA metrics and reporting for Quarterly Management Review.
Calibration Manage the calibration program to ensure all measurement tools and test equipment remain compliant with QMS and regulatory requirements.
Maintain calibration schedules, documentation, and status records for all controlled equipment.
Coordinate calibration activities with internal teams and external calibration service providers.
Ensure timely calibration, investigate out‑of‑tolerance conditions, and escalate issues as needed.
Support audit readiness by ensuring calibration records are complete, accessible, and accurate.