Manager Customer Quality - Pharma, Biotech or Medical Device
Peachtree City, GA
Full Time
Paid
Responsibilities
Job Description
Technical and disciplinary management of the team with all relevant individual tasks (management and control, personnel development, performance management, etc.)
Resource Planning for the Team
Support of QE Team members in fields of audits and meetings.
Timely processing of quality-relevant activities for customer projects within the QE Team.
Participation in the creation and improvement of internal quality standards according to regulatory or industrial standards and guidelines.
Mentoring function for QE Team members
Active participation in the goal achievement process within the GMS system. __
Execution of assigned quality tasks during product realization process according to the stage gate process (Phase I – IV)
Transfer of DMR including training (Phase IV) and support of the global production sites during transfer phase (Phase IV to Phase V), especially support of PQ / Process Validation stage. __
Qualifications
Qualifications
Very good knowledge of personnel management and leadership methods (Professional Level)
Professional Knowledge of applicable standards (e.g. ISO 13485, ISO 15378, 21 CFR 820, ISO 14971)
Good operating experience with standard office software (SAP, MS Excel, MS Word, MS Powerpoint) (Professional Level)
Solid knowledge of statistical / QM methods (Advanced Level)
Technical studies in the field of mechanical engineering, plastics engineering, medical engineering with extensive professional experience in the medical/pharmaceutical industry.
Minimum of 5 years professional experience in the field of Quality Engineering or Quality Management within a leadership role.
Additional Information
Counseling skills and conflict management methods
Knowledge and use of leadership methods (e.g. MCCL)
Risk identification and presentation
Fluent written and spoken English (A2 / B1)
Good analytical competence; experience in systematic problem-solving Techniques (e.g. KT, Six Sigma, Fault-Tree Analysis)
Well established moderation and presentation techniques
Solid structured way of working __
All your information will be kept confidential according to EEO guidelines.