Sr. Quality Engineer

Sr. Quality Engineer

Department:
Quality

Employment Type:

Full Time

Location:

Gainesville, FL

Reporting To:
Manager, Quality Engineering

Description

The Sr. Quality Engineer serves as the Quality owner for a defined orthopedic joint product portfolio (e.g., Knee, Hip, Shoulder), providing end-to-end quality engineering support across the full product lifecycle. This role ensures quality, regulatory compliance, and risk management from design through post-market support.

Key Responsibilities

* Serve as the Quality Engineering lead for a designated product line, ensuring product quality and compliance across the full lifecycle-from development through post-market support

* Lead quality activities for new product development, ensuring compliance with FDA, ISO, and design control requirements

* Partner with R&D to translate user needs into quality requirements, identify critical-to-quality characteristics, and support design reviews

* Drive risk management activities, including DFMEA, hazard analysis, and lifecycle risk file maintenance (ISO 14971)

* Lead verification & validation strategy, execution, and documentation

* Support design transfer and product launch, including inspection methods, control strategies, and process validation (IQ/OQ/PQ)

* Collaborate with Supply Chain on supplier qualification and readiness

* Act as the Quality lead for sustaining engineering activities, including investigation and resolution of nonconformances, CAPAs, and customer complaints

* Analyze product and field performance data to identify trends, risks, and improvement opportunities

* Lead change control activities to ensure continued product quality and compliance

* Drive root cause analysis and continuous improvement initiatives using a risk-based approach

* Serve as a cross-functional Quality SME, partnering with R&D, Manufacturing, Regulatory, Clinical, and Marketing teams

* Support audits and provide mentorship or technical guidance to junior engineers

Skills Knowledge and Expertise

Education:

* Bachelor's Degree in Engineering required; advanced degree preferred

Experience:

* 5+ years in medical device or highly regulated industry

* Demonstrated experience supporting full product lifecycle (design → launch → post-market)

* Experience in orthopedic implants or joint systems strongly preferred

Functional/Technical

Knowledge, Skills and Abilities Required:

* Deep understanding of:

* Design controls and lifecycle management

* Risk management (ISO 14971)

* Statistical analysis and sampling methods

* Working knowledge of:

* FDA 21 CFR Part 820

* ISO 13485 and global regulatory requirements

* Experience with

* Verification & Validation

* CAPA and root cause analysis

* Change control systems

* Familiarity with GD&T and inspection systems preferred