QUALITY MANAGER

  Wave Biotech,LLC is a growth driven research based company that manufactures innovative process equipment for pharmaceutical, biotech and medical applications. Our continuous growth and expansion has created the need for an experienced results driven Quality Manager.

 

RESPONSIBILITIES

& DUTIES:   Reporting directly to the Sr. Director, Operations our Quality Manager's responsibilities include the review and release of Cellbag product and equipment through the development and implementation of quality assurance standards, processes, and controls. Develops methods for inspection, testing, sampling, and training. Evaluates production capabilities and recommends improvements. Will develop quality assurance policies, procedures and work instructions to maintain high standards of quality, reliability and safety.

 

Directly responsible for the implementation and maintenance of the Quality Management System, reporting on the performance of the system for review and as a bias for continuous improvement and also coordinate and facilitate customer audits of the quality management system.

 

Other duties include, but are not limited to: 

1. Responsible for quality document review, and release of product.

2. Interface with suppliers to address non-conforming material, and other production issues.

3. Supervision of quality inspectors and technicians.

4. Scheduling quality inspections.

5. Clean room operations, monitoring and control.

6. Corrective and Preventive Actions.

7. Control of Non Conforming Material.

8. Gage Calibration System.

9. Document Control Distribution.

 

Other duties may be assigned commensurate with educational and professional qualifications. Travel is estimated to be 5-15% for biannual supplier audits and occasional meetings with clients and prospective suppliers.

Experience and Education:

BS degree in Science (Biology/ Chemistry) or Engineering plus 5-7 years Quality Assurance experience In the Biotechnology field. 

    Prefer:

? Certified Quality Manager

? Six Sigma training

? Lean Manufacturing Methodologies.

 

Knowledge, Skills and Abilities:

1. Knowledge of ISO 9000 and GMP Quality Management Systems.

2. Excellent written and verbal communication skills

3. Detailed orientated

4. Ability to work independently with minimal supervision.

 

 

Interested candidates, please respond to hr@wavebiotech.com