Quality Assurance Engineer - (850-1)

Wilson•Mahwah, NJ

2d•Onsite

About The Position

Our client, a global leader in the medical device industry, is seeking a Quality Engineer to join their Quality Engineering team. This position offers an exciting opportunity to support quality assurance initiatives, manufacturing process improvements, and validation activities in a highly regulated environment. The ideal candidate will be passionate about quality, compliance, and continuous improvement while collaborating with cross-functional engineering teams.

Requirements

Bachelor's degree in Biomedical Engineering, Mechanical Engineering, or a related Engineering discipline.
Minimum 1 year of engineering experience within a manufacturing or regulated industry.
Knowledge of Quality Management Systems (QMS) and Change Management processes.
Strong understanding of engineering and quality principles.
Excellent analytical, problem-solving, and organizational skills.
Strong written and verbal communication skills.
Proficiency in Microsoft Office (Word, Excel, and PowerPoint).
Ability to manage multiple priorities in a fast-paced environment.
Self-motivated with the ability to work independently while collaborating effectively across teams.

Nice To Haves

Experience within the Medical Device industry.
Familiarity with: ISO 13485
Good Manufacturing Practices (GMP)
Good Documentation Practices (GDP)
Knowledge of validation protocols, risk-based methodologies, and statistical analysis.
Experience supporting regulated manufacturing environments.
Ability to influence cross-functional teams while serving as the voice of Quality.

Responsibilities

Provide quality engineering support for manufacturing operations and quality assurance activities.
Develop and implement process controls, inspection methods, and quality improvement initiatives.
Support validation projects for new manufacturing equipment and production processes.
Develop, execute, and approve First Article Inspection (FAI) strategies.
Create, update, and maintain Standard Operating Procedures (SOPs) and inspection plans through the change management process.
Partner with Manufacturing Engineering, Sterility Assurance, and Product Design teams to ensure quality and regulatory compliance.
Lead and support continuous improvement initiatives that enhance product quality and operational performance.
Apply risk-based quality principles to manufacturing processes and equipment maintenance.
Ensure compliance with applicable regulatory requirements and quality standards.
Participate in problem-solving, root cause investigations, and corrective/preventive action activities.
Serve as the quality representative when collaborating with cross-functional teams.