SUMMARY
In support of Quality Assurance program acts as the technical specialist. Review and approve product MPs.

FUNCTIONS
- Approve process validation protocols and reports for mfg. processes.
- Represent Quality on incident triage team.
- Approve Environmental Characterization reports.
- Release of sanitary utility systems.
- Approve planned incidents.
- Represent QA on NPI team.
- Lead investigations.
- Own site quality program procedures.
- Designee for QA manager on local CCRB.

EDUCATION/LICENSES
Doctorate degree and 2 years of directly related experience or Master's degree and 6 years of directly related experience or Bachelor's degree and 8 years of directly related experience or Associate's degree and 10 years of directly related experience or High school diploma / GED and 12 years of directly related experience.

Sciences, preferably Mechanical or Chemical Engineering, Chemistry, Biology or Microbiology

COMPETENCIES/SKILLS
- Project management skills.
- Strong organizational skills, including ability to follow assignments through to completion.
- Initiate and lead cross functional teams. Enhanced skills in leading, influencing, and negotiating.
- Strong knowledge in area of expertise.
- Collaborate and coordinate with higher level outside resources.
- Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation, and processes development.
- Demonstrated ability to interact with regulatory agencies.
- Strong word processing, presentation, database and spreadsheet application skills.
- Strong communication (both written and oral), facilitation and presentation skills.
- Strong skill in working independently and to effectively interact with various levels.
- Advanced data trending and evaluation.
- Ability to evaluate compliance issues.
- Demonstrate Values/Leadership Practices.

Preferred Qualifications
Knowledge in inspection and packaging processes validation. Knowledge in medical devices.

Job Type: Full-time

Work Location: One location

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