Quality Operations Manager

2 months ago

Elkton, United States Synerfac Technical Staffing Full time

The Manager, Quality Operations is responsible for managing quality operations functions within the respective manufacturing facility. S/he is responsible for ensuring compliance with the applicable regulations of all countries in which the company either manufactures or distributes products including, but not limited to the U.S. Quality System Regulation, Japanese Pharmaceutical Affairs Laws, the Canadian Quality System Regulation, and the Medical Device Directive.

Job Details:

* Establish and promote a work environment that supports compliance with the Quality System.

* Support the development of efficient and effective methods for meeting Quality System requirements.

* Prepare, communicate, and evaluate team goals and objectives for continual improvement of the quality system. Ensure linkage to Strategic Quality Plan.

* Manage a team of Quality Engineers in driving robust problem solving, NC reduction and continual improvement efforts. Drive values stream optimization through the application of proven methodologies such as Six Sigma, LEAN, Kaizen events etc.

* Promote production line value stream characterization and optimization efforts. Ensure process control plans (SPC, sampling, inspection methods) are appropriate and effective.

* Ensure operations related CAPA activities are managed in a complete and timely manner.

* Effectively partner with Operations Managers and Supervisors to develop and implement strategies which promote the Quality Culture throughout operations.

* Ensure transfers to manufacturing are data driven and robustly executed.

* Partner with internal support functions (i.e. laboratory operations, calibration & metrology, supplier control, distribution etc.) to achieve functional excellence.

* Manage Quality Assurance inspection staff and processes related to incoming inspection and release of finished goods.

* Manage Quality Control staff activities.

* Support activities associated with environmental controls and monitoring.

* Prepare for, and support compliance audit activities in Operations

* Maintain Quality Performance Indicators in support of management oversight activities

* Support the preparation and conduct of compliance forums such as Quality System Management Reviews, Change Board Meetings, NC/CAPA Board meetings etc.

* Promote the professional growth and development of staff personnel

* Performs other job-related duties assigned


Qualifications:

* Knowledge of national and international regulations applicable to medical devices including Quality System Regulations, 21 CFR 820, 21CFR 803 and 804 (MDR regulations), Canadian Medical Device Regulations, ISO 14971, ISO 13485, and MDR etc., LEAN

* Prior experience in medical device manufacturing environment coupled with certifications from ASQ preferred

* Ability to identify the strategic direction of the quality assurance system required

* Ability to analyze and interpret all regulatory and quality guidelines as needed

* Demonstrate a strong understanding and working knowledge of the Quality Sciences (Acceptance Sampling, SPC, continual improvement, Six Sigma, LEAN, Design of Experiments, COQ, Cause & Effect analysis etc.)

* Demonstrate a strong 'business partner' approach and attitude providing creative and innovative solutions that meet quality standards

* Bachelor's degree in engineering required

* Minimum of 10 years Quality Assurance experience

* Minimum 5 years management experience

* Six Sigma/LEAN experience, expertise preferred

* Must be proficient in Microsoft Excel, Word, PowerPoint, and Outlook

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