Quality Engineer
Actalent
Phillipsburg, NJ (In Person)
$88,400 Salary, Full-Time
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Job Description
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. Utilize Quality tools such as FMEA, Control Plan, and Process Flow. Skills medical device, validation verification, capa, qms, iso 14971, sterilization, process flow Top Skills Details medical device,validation verification,capa,qmsAdditional Skills & Qualifications Education:
Bachelor's Degree in Engineering or related field of studyComputer Skills:
Microsoft Excel, Word, Etc. Proficient in communication (verbal and written) inEnglish Physical Demands:
Standing/sitting; working at a computer for normal periods Experience Level Intermediate Level Job Type & Location This is a Contract position based out of Phillipsburg, NJ. Pay and Benefits The pay range for this position is $40.00 - $45.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:- Medical, dental & vision
- Critical Illness, Accident, and Hospital
- 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Phillipsburg,NJ.
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