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Quality Engineer

Eingestellt von Randstad Engineering

Gesuchte Skills: Engineer, Engineering, Support

Projektbeschreibung

Quality Engineer with experience in a medical device related manufacturing environment. You should have experience with supplier quality, audits, complaints, CAPA investigations and be familiar iwth ISO 9001 and 21CFR Part 820. This is a temp to perm position in Clearwater, FL.

RESPONSIBILITIES

- Ensure quality standards of the company are maintained within the facility procedures, policies, purchased components and manufactured products
- Lead complaint investigations, CAPA investigations, lead supplier audits, drive supplier quality, conduct internal audits and drive continuous improvement projects throughout the plant
- Quality lead for any facility expansions, software validations, equipment qualifications and / or process validations required to support existing / new processes
- Participate in third party audits and conduct training when needed
- 70% - Lead resolution of quality (customer and internal) issues utilizing sound problem solving methodologies supporting inquiries, SCARs, complaints, CAPAs, internal or external audits
- 25% - Project Management Supplier Quality Validation activities Satisfy customer requests and complete the associated documentation
- 5% - Management of equipment calibration for measuring, inspection and process equipment

REQUIREMENTS

- Bachelors in Engineering or Science (higher degrees are a plus)
- CQA or proof of completion of a lead auditor training course is required. CQE and green belt training or higher are preferred
- 5+ years experience in the quality field, working with ISO and GMP quality systems with 3+ years in a manufacturing environment
- Strong background in ISO 9001 and 21 CFR Part 820 required.
- Excellent analytical / problem solving, project management, interpersonal and organizational skills required.
- Proficient with Microsoft Access, Excel and Word required.

Projektdetails

  • Einsatzort:

    Clearwater, Vereinigte Staaten

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Randstad Engineering