Senior Quality Engineer

Genesis10 is currently seeking a Senior Quality Engineer for a contract position with a Global Medical Technology Company located in Mahwah, NJ. This is a 12+ month contract opportunity.

This is a Senior Quality Engineer role focused on providing quality engineering support for a portfolio of products. The position is specifically tasked with supporting EU-MDR initiatives by developing and implementing methods for process control, process improvement, testing, and inspection to ensure products are compliant with all applicable regulations.

Responsibilities:

• Provide quality engineering support in quality assurance, control and preventative activities
• Support EU-MDR initiatives for a portfolio of products
• Develop and implement methods and procedures for process control, process improvement, testing and inspection
• Support First Article Inspection (FAI) strategy development, execution, and approvals
• Support Production Part Approval Process (PPAP)
• Manage change control and change impact assessments
• Support SOP and Risk Documentation updates and reviews
• Oversee equipment and process validations
• Advocate and lead the execution of initiatives and projects to enhance quality performance

Requirements:

• Bachelor's Degree in Biomedical Engineering, Mechanical Engineering or related field
• 4+ years of experience in the industry
• Experience supporting EU-MDR programs/initiatives (2+ years)
• Knowledge of Change Management and Quality Management Systems (QMS) principles
• Great problem solving and critical thinking skills
• Able to independently use engineering rationale to make decisions
• Excellent communication skills and attention to detail
• Proficient with Microsoft Word, Microsoft Excel and PowerPoint
• Self-starter with an efficient work style and ability to handle multiple tasks
• Ability to be the voice of Quality when dealing cross-functionally
• Excellent English (both oral and written)

Desired skills:

• Firm understanding of Med Device concepts
• Familiarity with ISO 13485 and EU Regulations, GDP, GMP concepts
• Knowledge of Risk-Based and statistical concepts

Pay range: $51.91 - $61.91 per hour

Only candidates available and ready to work directly as Genesis10 employees will be considered for this position.

If you have the described qualifications and are interested in this exciting opportunity, please apply!

Ranked a Top Staffing Firm in the U.S. by Staffing Industry Analysts for six consecutive years, Genesis10 puts thousands of consultants and employees to work across the United States every year in contract, contract-for-hire, and permanent placement roles. With more than 300 active clients, Genesis10 provides access to many of the Fortune 100 firms and a variety of mid-market organizations across the full spectrum of industry verticals.

For contract roles, Genesis10 offers the benefits listed below. If this is a perm-placement opportunity, our recruiter can talk you through the unique benefits offered for that particular client. Benefits of Working with Genesis10:

• Access to hundreds of clients, most who have been working with Genesis10 for 5-20+ years.
• The opportunity to have a career-home in Genesis10; many of our consultants have been working exclusively with Genesis10 for years.
• Access to an experienced, caring recruiting team (more than 7 years of experience, on average.)
• Behavioral Health Platform
• Medical, Dental, Vision
• Health Savings Account
• Voluntary Hospital Indemnity (Critical Illness & Accident)
• Voluntary Term Life Insurance
• 401K
• Sick Pay (for applicable states/municipalities)
• Commuter Benefits (Dallas, NYC, SF, and Illinois)

For multiple years running, Genesis10 has been recognized as a Top Staffing Firm in the U.S., as a Best Company for Work-Life Balance, as a Best Company for Career Growth, for Diversity, and for Leadership, amongst others. To learn more and to view all our available career opportunities, please visit us at our website.

Genesis10 is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.