Staff Quality Engineer

2 weeks ago


Hazelwood, United States CareerBuilder Full time

Description
1. Use expert level knowledge of the product and manufacturing process, ensure data driven decisions are utilized to drive science-based quality judgements.
2. Support root cause analysis and other problem-solving activities and recommend corrective and preventative actions. Utilize data, trends, training effectiveness, complaints, and non-conforming material to support holistic approach.
3. Work cross functionally across global sites and maintain relationships with global departments.
4. Actively maintain knowledge base of current industry best practices and industry trends.
5. Review periodic trend reports as required (QSMR, CPV), identify negative trends and recommend appropriate actions.
6. Lead risk assessment activities, review/revise existing risk assessments through process feedback and identify gaps for risk management activities.
7. Participate in regulatory and agency inspections, audits, and investigations. Act as quality expert and interact with auditors.
8. Provide quality expert support for continuous improvement projects as needed.

Minimum requirements: Bachelor's degree

Minimum qualifications
BS in scientific or engineering field, and a minimum of 8 years of experience
If MS in scientific or engineering field, a minimum of 6 years of experience.
Medical device or other FDA regulated industry experience required.
Must possess effective written and verbal communication skills. Must be able to communicate effectively across all levels of management.
Must have expert knowledge of the interpretation and application of relevant Domestic and International regulations and Industry Standards (MDSAP, 21CFR820, ISO 13485, QSR, etc.)
ASQ certification is desired but not required.

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