Quality Engineer

Our client in the Clearwater FL area is looking to add a Quality Engineer to their staff via a 3 moyh contract-to-hire opportunity. The quality engineer will ensure that the quality standards of the company are maintained within the facility procedures, policies, purchased components and manufactured products. The Quality Engineer will serve as a delegate to the Quality Manager. He / She will lead complaint investigations, CAPA investigations, lead supplier audits, drive supplier quality, conduct internal audits and drive continuous improvement projects throughout the plant. He / She will be quality lead for any facility expansions, software validations, equipment qualifications and / or process validations required to support existing / new processes. The Quality Engineer will participate in third party audits and conduct training when needed.

RESPONSIBILITIES

- 70% Lead to resolution 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

- Minimum four year engineering or science degree required.
- 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.
- Minimum 3-5 yrs. experience in manufacturing environment.
- Minimum 5 years experience in the quality field, working with ISO and GMP quality systems.
- CQA or proof of completion of a lead auditor training course is required. CQE and green belt training or higher are preferred

BENEFITS