Senior Quality Assurance Engineer

Job Title: Senior Quality Assurance Engineer
Location: Mahwah, NJ
Type: Contract
Compensation: $55-$60.51/hr
Work Model: Hybrid- onsite and remote

Responsibilities

• First Article Inspection (FAI) strategy development, execution, and approvals.
• Production Part Approval Process (PPAP)
• Change control and change impact assessments
• Support SOP and Risk Documentation updates and reviews
  Equipment and Process validations
• And more

• Bachelor’s Degree - Biomedical Engineering, Mechanical Engineering or related field
• 4 + years of experience in industry required
• Experience supporting EU-MDR programs
• Knowledge of Change Management and Quality Management Systems (QMS) principles.
• Firm understanding of Med Device concepts highly desirable.
• Familiarity with ISO 13485 and EU Regulations, GDP, GMP concept highly desirable.
• Excellent communication skills and attention to detail.
• Good understanding of engineering and quality concepts / theories.
• High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.
• Self-starter with efficient work style and ability to handle multiple tasks in a fast-paced environment.
• Be willing to work as part of a multi-site team.
• Have knowledge of Risk Based and statistical concepts is desirable.
• Problem solving and analytical skills.
• Be able to build strong relationships by fostering open communications, respect and trust. Strong team player and acts with a customer service/stakeholder focused approach.
• Ability to be the voice of Quality when dealing cross functionally.
• Excellent English (both oral and written).
• Up to 10% travel may be required

System One, and its subsidiaries including Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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Ref: #558-Scientific