Senior QA Engineer - Medical Devices

Must Haves: • Bachelor’s Degree in Engineering field• Able to independently use engineering rationale make decisions (4+)• Knowledge/Experience with Validation (2+)• 4 + years of experience in industry required• Experience supporting EU-MDR programs Knowledge of Change Management and Quality Management Systems (QMS) principles.• Good understanding of engineering and quality concepts / theories.• Have knowledge of Risk Based and statistical concepts is desirable.  Desired Skills:• Experience developing or approving SOPs• Firm understanding of Med Device concepts highly desirable.• Familiarity with ISO 13485 and EU Regulations, GDP, GMP concept highly desirable.• FAI, PPAP   About Matlen Silver Experience Matters. Let your experience be driven by our experience. For more than 40 years, Matlen Silver has delivered solutions for complex talent and technology needs to Fortune 500 companies and industry leaders. Led by hard work, honesty, and a trusted team of experts, we can say that Matlen Silver technology has created a solutions experience and legacy of success that is the difference in the way the world works.   Matlen Silver is an Equal Opportunity Employer and considers all applicants for all positions without regard to race, color, religion, gender, national origin, age, sexual orientation, veteran status, the presence of a non-job-related medical condition or disability, or any other legally protected status. If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at email and/or phone at: info@matlensilver.com // 908-393-8600 At The Matlen Silver Group, Inc., W2 employees are eligible for the following benefits: Health, vision, and dental insurance (single and family coverage)401(k) plan (employee contributions only)