Quality Engineer

Genesis10 is currently seeking a Quality Engineer for a contract position with a Global Medical Technology Company located in Portage MI. This is a 5 month contract opportunity.

As a Quality Engineer you will play a critical role in strengthening product reliability across the lifecycle from post-market insights to product improvements that shape future innovations. This role offers meaningful impact cross-functional collaboration and the opportunity to influence products used by healthcare professionals worldwide.

Responsibilities:

• Investigate product failures by reviewing design history manufacturing records and field performance data to identify root causes and improvement opportunities
• Analyze and trend post-market product complaint data delivering regular data-driven insights to divisional quality leadership
• Update risk management documentation to reflect post-market findings and product changes ensuring continued product safety and effectiveness
• Participate in cross-functional product improvement teams to define prioritize and execute corrective and preventive actions
• Initiate track and document commercial product holds ensuring timely resolution and accurate records
• Support business units and commercial teams by providing post-market quality expertise and technical guidance
• Facilitate and coordinate subject matter experts to develop technical documentation for product field action assessments and present findings to governance boards and senior leadership
• Guide research and development teams through quality system requirements to ensure product changes comply with regulatory and quality standards including reviewing change documentation for technical robustness

Requirements:

• Bachelors Degree in Engineering (any discipline) required
• 2 years of good communication skills
• 2 years of documentation and print review experience
• 2 years of quality investigation experience

Desired skills:

• 1 years of NC/CAPA experience preferably in TrackWise
• 1 years of print and document review experience
• Experience with data trending
• Experience in the medical device or pharmaceutical industry is preferred

Pay range: $29.90 - $39.90 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.

Required Experience:

IC