Quality Support Technician I (Pittsburgh, PA) at Smith Nephew

Pittsburgh, Pennsylvania, United States -

Full Time

Start Date

Immediate

Expiry Date

19 Jun, 26

Salary

0.0

Posted On

21 Mar, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Management System Review, GDP Requirements Adherence, Device History Records Review, Liaison Coordination, Nonconformance Escalation, CAPA Support, Calibration Management, Technical Oversight, Complaint Triage, Investigation Coordination, Attention To Detail, Critical Thinking, Problem Solving, Communication, Collaboration, Microsoft Office Proficiency

Industry

Medical Equipment Manufacturing

Description

Quality Technician 1 (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? 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. What will you need to be successful? 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 Competencies 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 You Unlimited. We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve. Inclusion and Belonging- Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging, Learn more about Employee Inclusion Groups on our website ( https://www.smith-nephew.com/). Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement Work/Life Balance: Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program Flexibility: Hybrid Work Model (For most professional roles) Training: Hands-On, Team-Customized, Mentorship Extra Perks: Discounts on fitness clubs, travel and more! #LI-HYBRID Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability. Stay connected by joining our Talent Community. We're more than just a company - we're a community! Follow us on LinkedIn to see how we support and empower our employees and patients every day. Check us out on Glassdoor for a glimpse behind the scenes and a sneak peek into You. Unlimited., life, culture, and benefits at S+N. Explore our website and learn more about our mission, our team, and the opportunities we offer. Smith+Nephew is a global medical technology company. We design and manufacture technology that takes the limits off living. We support healthcare professionals to return their patients to health and mobility, helping them to perform at their fullest potential. From our first employee and founder, T.J. Smith, to our team today, it’s our people who make Smith+Nephew a unique place. Yes, we love to innovate and develop exciting technologies, and we offer competitive salaries and progressive benefits. But it’s our culture - of Care, Collaboration and Courage - that really sets us apart. Through a spirit of ownership and can-do attitude we work together to win. We’re a company of people who care about each other, about our customers and their patients, and about our communities. Together, we fulfill our shared purpose of Life Unlimited.

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Responsibilities

The Quality Support Technician will review Quality Management System Records, including DHRs and service records, to ensure compliance with procedures and GDP requirements, while also acting as a liaison between Robotics, Contract Manufacturers, and Service Teams. Key duties involve providing quality oversight for product release, managing complaint triage, supporting the CAPA program, and maintaining the calibration program for measurement tools.