Quality Assurance Engineer
Mahwah, NJ (minimum 3 days on-site)
Role Overview:As a Quality Engineer, you will provide quality engineering support across quality assurance, control, and preventative activities within operations and other business functions. You'll develop and implement methods and procedures for process control, process improvement, testing, and inspection to ensure products meet design and quality standards.
You will support:
- Validation projects for new equipment and processes introduced to the plant
- First Article Inspection (FAI) strategy development, execution, and approvals
- Standard Operating Procedure (SOP) and inspection plan creation/updates through change management
You'll collaborate with Manufacturing Engineering, Sterility Assurance, and Design teams to implement risk-based process controls and equipment maintenance measures for new equipment.
This is an individual contributor role requiring independent judgment and professional expertise, typically suited to someone with a university degree or equivalent practical experience.
Required Qualifications:- Bachelor's degree in Biomedical Engineering, Mechanical Engineering, or related field
- 1+ years of industry experience
- Knowledge of Change Management and Quality Management Systems (QMS)
- Strong problem-solving and critical thinking skills
- Ability to independently apply engineering rationale to decisions
- Experience with validation processes
- Excellent communication skills (oral and written) and attention to detail
- Proficiency in Microsoft Word, Excel, and PowerPoint
Preferred Qualifications:- Understanding of medical device concepts, ISO 13485, GDP, and GMP
- Experience developing or approving SOPs
- Familiarity with risk-based and statistical concepts
- Self-starter, comfortable in a fast-paced, multi-site team environment
Travel: Not typically required; occasional travel possible (up to 10%)
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