Roles & Responsibilites:
Working conditions are normal for an office environment. Work may require occasional weekend and/or evening work.
Occasional work inside manufacturing clean rooms where gowning is required.
Knowledge of FMEA methods and process.
Proficient knowledge with statistical software packages and MS Office.
Excellent verbal and written communication skills demonstrated through interactions internally and externally.
Ability to independently lead cross-functional teams in support of continuous improvement projects.
Ability to work both independently and in conjunction with a team.
Ability to develop working relationships with both internal and external customers.
Effective organization and project management skills.
Effective troubleshooting and problem solving skills.
SME in statistics and statistical software (Minitab or JMP preferred).
Education & Experience:
Bachelor's degree in Chemistry, Engineering, Biology or other related field required.
Five or more years of Quality Engineering/Quality Assurance experience in a pharmaceutical, medical device or manufacturing industry required.
CSSGB, CSSBB and/or CQE preferred.
Strong working experience in tracking and trending of data.
Strong working experience with control charts, process capability and presenting information.
Six Sigma tools experience (Black or Green belts) strongly preferred.
Experience with Injectable dosages preferred.