Quality Engineer Job Tulsa area,Oklahoma USA,Engineering

Job Details

Job Title:

Quality Engineer

Location:

Phillipsburg, NJ
Type:
Contract
Compensation: $40 - $45 hourly
Contractor Work Model:
Onsite
Duration: 6 month assignment. Maybe longer

Responsibilities

Possesses knowledge of FDA 21 CFR 820, ISO 13485, ISO 14971, and international medical device regulations (MDR)

Understands Sterilization qualification and maintenance as it relates to medical devices

Ensures compliance to QSR and GMP in assigned areas

Manage corrective and preventive action process from investigation through effectiveness checks

Maintain Design History and Technical Files, and documentation for internal and external audits

Organizes and prioritizes assigned tasks to ensure project meets expectations and timelines

Create and execute department and company training

Review Validation Protocols and Reports

Utilizes Quality tools such as FMEA, Control Plan, and Process Flow

Background in Risk Management a plus

Possesses competent technical writing skills

Qualifications

Education:

Bachelor’s Degree in Engineering or related field of study
Skills/Licensure:
Computer skills (Microsoft, Excel, Word, etc.), Verification and Validation, proficiency in communicating (verbal and written) in English
Experience:

Equivalent work experience in an ISO regulated/Medical Device related background
Physical Demands:
Standing/Sitting, working at computer for normal periods

System One, and its subsidiaries including Joulé, ALTA IT Services, 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.

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