MD - Entry Level QA Manager

The Quality Manager will work to continuously improve Novo Health Services’ Quality Systems while maintaining compliance to ISO and FDA requirements. This position will also help improve customer satisfaction through specified improvement projects.

ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:

OPERATIONS –

Oversee QA Techs working on all 3 shifts.

Develop, implement and maintain an operator training/certification program that will prepare production operators to perform the requirements of their job(s) in such a manner that meets quality and efficiency objectives.

Monitor pass/fail rates on training audits.

Schedule and coordinate process audits conducted in production.

Responsible for the coordination of bioburden test studies, including data analysis.

Responsible for performing sterilization release activities.

Responsible for the coordination of calibration activities.

Owns the product nonconformity process.

COMPLAINT HANDLING –

Track and trend customer complaint data and help identify areas for improvement.

Work to develop solutions to lower customer complaint rate, including solution implementation.

Run weekly Customer Quality Improvement Team meetings.

Respond to customers (both internal and external) regarding complaints as requested.

R&D/ENGINEERING SUPPORT –

Assist in the design, collection, statistical analysis and reporting of device robustness studies

SUPPLIER QUALITY –

Review new supplier requests for approval.

Perform supplier audits, as necessary.

Other responsibilities may be assigned & not all responsibilities listed may be assigned.

POLICIES –

Know and follow Novo Health Services policies and procedures and assure that direct reports know & follow Novo Health Services policies & procedures related to work activities performed in area of responsibility.

TRAINING –

Complete training in area of responsibility and assure that direct reports are trained in area of responsibility within allowed time-period. Training is required for changes in existing policies & procedures, for new assignments and for implementation of new policies & procedures. Complete required periodic re-training and assure that required periodic re-training takes place for direct reports in areas such as environmental health & safety.

SAFETY –

Set standards for safe behavior. Recognize and reward safe behavior in others. Ensure that direct reports employ safe practices. Enforce safety policies & procedures. Evaluate staff member’s safety performance & insure that safety is a part of each direct report’s performance appraisal.

SUPERVISORY RESPONSIBILITIES –

Responsible for the supervision and management of the facility’s QA Technicians team, Quality Engineer, and Quality Analyst. Guide and direct the Quality staff, conduct employee performance reviews and recommend wage adjustments. Novo Health Services is a service company which requires that you are always providing some level of service to either an internal or external customer. You are expected to make decisions that will in effect, positively impact and exceed the expectations of the customer base you serve. Accuracy, delivering on our commitments and the manner in which we execute each transaction must be done in such a manner that it positively spreads our organization’s reputation. Although we cannot always choose the specific work assigned to us, we can however determine the attitude, behavior and personality we portray in completing our work.

EXPERIENCE:

Advanced ASQ certifications, such as CQE, CQA or CRE preferred.

2+ years in manufacturing QA position (preferably in the medical device industry).

Prior experience regarding sterilization is preferred.

Training in statistical analysis and techniques.

Experience in ISO environment, training in ISO auditing preferred.

Experience dealing with service and customer related quality issues.

EDUCATION:

High school diploma required.

KNOWLEDGE, SKILLS, ABILITIES:

Proficient in Microsoft Office

Flexibility with respect to hours and work performed