Quality Operations/Compliance Mgr

ESSENTIAL FUNCTIONS:

1.        Support of day-today process / product / system issues at manufacturing facilities.

2.        Lead cross site CAPA’s for process / system improvements.

3.        Lead/Support plant remediation projects as applicable

4.        Utilize benchmarking of best in class processes to provide information for continuous improvement.

5.        Co-ordinate & monitor all Quality KPI’s for Operations Quality group including completion of monthly reports.

6.        Identify and lead improvement initiatives where required to maintain KPI targets.

7.        Develop, implement and guide the Mfg sites through continuous quality improvements.

8.        Conduct or participate as needed in internal audits.

DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS

1.        Support Cardinal corporate continuous improvement initiatives

2.        Develop and/or deliver Quality Management System  training

3.        Other duties as assigned with or without accommodation.

Minimum Requirements

Education:

BS or MS in Electrical, Mechanical, Chemical Engineering, or related field

Experience:

Minimum of 5 years of experience in a Regulatory Compliance and/ or Manufacturing  Quality environment within the medical devices sector.

Preferred Skills/Qualifications:

Communication: Ability to communicate effectively in multi-discipline environment, and across cultures and levels of organizations

Project Management: Ability to organize and manage multiple priorities and teams.

Organizational Management: Ability to directly manage teams and individuals to achieve high levels of performance.

Medical Device industry experience desired

Skills/Competencies:

Certified Lead Auditor (RABQSA, ASQ, or equivalent) with application experience

Knowledge of ISO Quality System Standards and FDA Quality System Regulation is required.

Knowledge of risk management (FMEAs), process validation, statistical process control, and statistical sampling plans is desirable.

Strong technical writing abilities.

Strong verbal/written skills