Senior Quality Assurance Engineer

    • Stryker
  • Fort Lauderdale, FL
  • Posted 32 days ago | Updated 8 hours ago

Overview

On Site
Full Time

Skills

Recruiting
Global sourcing
Planning
Operations
Manufacturing
Productivity
Data
Continuous improvement
Analytical skill
ROOT
Goal oriented
FOCUS
SAFE
Inspection
Mentorship
Quality assurance
Medical devices
Management
Documentation
FDA
ISO 13485
GDP
GMP
Risk management
Corrective and preventive action
Auditing
Statistics
Regulatory Compliance
Problem solving

Job Details

Stryker is hiring a Senior Quality Assurance Engineer in Weston, Florida to support Joint Replacement! In this role, you will perform internal and external investigations of nonconformances and corrective actions investigations and develop/execute on strategies to reduce occurrence of quality issues (examples: non-conformances, reworks, corrective actions).

In addition, you will work closely with Operations, Global Sourcing and Planning, Advanced Operations, and other manufacturing locations to standardize quality improvements.

Who we want
  • Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
  • Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
  • Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
  • Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
  • Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.


What you will do
  • Issue, track, and resolve internal and external (supplier) non-conformances and corrective actions.
  • Liaise with internal customers to ensure effective problem resolution.
  • Evaluate and determine the internal requirements for approval of all site specific supplier change requests (SCRs).
  • Work with internal customers in support of supplier certification activities, including skip-lot, product source and reduced inspection requirements.
  • Mentor junior quality engineers on quality assurance.


What you need

Required:
  • Bachelor's degree in engineering or related discipline.
  • 2+ years of related experience in a regulated industry.

Preferred:
  • Experience in the Medical Device industry preferred.
  • Ability to manage project timeline and documentation of completed work.
  • MS, CQE, or CRE preferred.
  • Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) desired.
  • Familiarity with ISO 13485, GDP, GMP desired.
  • Strong knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics).
  • Experience in working in a compliance risk situation.
  • Highly developed problem-solving skills.
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