· Strong computer literacy

· Strong knowledge of print reading and GD&T

· Knowledge of ISO 9000:2000, ISO 13485:2003, and FDA GMP requirements

· Strong interpersonal, verbal, and written communication skills

· Strong organizational skills

· Ability to work with minimal supervision

· Demonstrable ability to take initiative and manage multiple projects

· Demonstrable ability to work with customers

Education / Experience:

· Bachelors’ degree in engineering, quality or related field or equivalent experience.

· 1 to 2 years quality/regulatory experience preferred in an ISO and FDA environment

· 2 to 3 years auditing experience (ISO and GMP) a plus

Licenses or Certifications:

· American Society for Quality certification as Quality Engineer preferred

NOTE - Please include the job order number (7) when applying for this position

Responsibilities: Objective:

Improve communication and systems utilized by external and internal customers and suppliers. Support facility Quality Objectives by leading efforts to meet goals established through business planning and performance management.

Essential Functions of Job:

· Represent Quality in the Advanced Quality Planning process.

· Conduct training sessions for quality related topics

· Implement systems and procedures to meet ISO9000:2000, ISO 13485:2003 and the FDA Quality System Regulations and conformance to various customer requirements

· Corrective/Preventive Action system activities including complaint investigations

· Non-Conforming Material System/MRB

· Development and implementation of statistical incoming and in-process sampling/control plans

· Data acquisition of SPC data.

· Resource for fixture and gage development.

· Application of BAAN as related to the Quality Department and integration with other departments

· Develop and review of plans and protocols