Senior Quality Assurance Engineer

System One; Mahwah (NJ); Hybrid; USD 76,000 - 83,000; Part time

Job summary

System One in Mahwah, NJ is seeking a Senior Quality Assurance Engineer for a contract role. The position combines hybrid onsite and remote work, with a minimum of three days per week onsite, focusing on quality assurance, control and preventative activities across operations.

The ideal candidate will hold a related engineering degree, have 4+ years of experience, and support EU-MDR programs. Strong communication, analytical skills, and proficiency in MS Office are required, along with

Qualifications

• Bachelor’s degree in a relevant engineering field.
• Strong communication and attention to detail required.
• Proficiency with MS Word/Excel/PowerPoint.

Responsibilities

• Develop and implement methods and procedures for process control, testing and inspection to ensure product quality.
• Lead quality initiatives to improve performance and ensure regulatory compliance.
• Support FAI, PPAP, change control, validation activities, and risk/documentation updates.

Skills

Communication skills

Attention to detail

Analytical skills

Team player

Multitasking

Cross-functional collaboration

Voice of Quality

Education

Bachelor’s Degree - Biomedical Engineering, Mechanical Engineering or related field

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

Job Title: Senior Quality Assurance Engineer
Location: Mahwah, NJ
Type: Contract
Compensation: $55- $60.51/hr
Work Model: Hybrid-onsite and remote (Min of 3 days onsite)

Overview

As a Senior Quality Engineer, you will provide quality engineering support in quality assurance, control and preventative activities within operations and other business functions.

Responsibilities

• You will be tasked with developing and implementing methods and procedures for process control, process improvement, testing and inspection to ensure that the products are free of flaws and function as designed.
• You will advocate and lead the execution of initiatives & projects to enhance quality performance within the business and ensure compliance to regulations and standards.
• You will be expected to support:
  • First Article Inspection (FAI) strategy development, execution, and approvals.
  • Production Part Approval Process (PPAP)
  • Change control processes and change impact assessments
  • Equipment and Process validations
  • SOP and Risk Management documentation updates and reviews
  • And more

Requirements

• Bachelor’s Degree - Biomedical Engineering, Mechanical Engineering or related field
• 4 + years of experience in industry required
• Experience supporting EU-MDR programs
• 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.
• 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.
• Up to 10% travel may be required

Preferred

• Firm understanding of Med Device concepts highly desirable.
• Familiarity with ISO 13485 and EU Regulations, GDP, GMP concept highly desirable.
• Have knowledge of Risk Based and statistical concepts is desirable.

System One, and its subsidiaries including Joulé and 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.