Job Description
- Work with QA/RA Director in maintaining Quality Systems policies and procedures to ensure regulatory compliance by following FDA QSR, and ISO requirements
- Support the validation team in evaluating and approving plans, reports and data generated to qualify processes, equipment and computer systems. Provide QA oversight and review during the qualification/validation planning process. Perform compliance review of validation protocols and final reports in support of validation effort
- Maintain internal audit program including master schedule, audit scheduling, audit team designations and reporting
- Maintain and facilitate deviation management system.
- Maintain Supplier Approval files.
- Analyze and provide data analysis from complaints, CAPA’s, NCR’s, other quality indicators as assigned.
- Perform acceptance reviews on incoming products per specifications, including raw materials, labels, packaging
- Create or update QS procedures. Maintain procedures relevant to scope of job description.
- Coordinate and document complaint investigations.
- May participate in Third Party audits as support to QA/RA Director
- Other duties as assigned
Job Requirements
- 1-3 years experience as a Quality Engineer
- Bachelors Degree in the sciences or engineering field required (work experience in ISO13485 or ISO9001 regulated establishment)
- Familiarity with interpreting regulations and quality systems. Working knowledge of FDA, QSR or ISO13485 standards preferred
- Experience in generating and reviewing validation plans
- Quality system audit experience in a medical device or FDA regulated environment
- Exceptional organizational skills and ability to plan and implement resolutions to technical problems
- Good interpersonal and communication skills
- Able to effectively manage time to meet assigned deadlines and prioritize multiple work assignments
- Ability to work independently
- Excellent writing skills
- Computer literacy: WORD, EXCEL, ACCESS, working knowledge of Windows
Country: USA, State: New Jersey, City: Somerset, Company: Ivoclar Vivadent Manufacturing, Inc..
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