Manager, Quality Systems

The incumbent provides direction and supervises the Quality Improvement (Design) and technical work unit team to ensure Quality Systems Improvement Strategies are implemented following compliance with Laws & Regulations. Manages work unit direct report people recruitment, attendance, leave of absences, performance management / monitoring. Incumbent decisions are based on functional area objectives and company policies and procedures. Also, provide advice and recommend changes to operational policies. Manage and execute the support to the ECO process to ensure the involvement of appropriate SME’s. Will act as the focal point of contact for all change leaders including R&D SME’s.

Essential Functions & Accountabilities:

Accountable for:

• Quality Improvement Projects and Calibration / Preventive Maintenance Area administration.

• Monitor Quality Systems Performance

• Establishing goals and objectives

• Reviewing/ Approving SOP Changes, IT Requirements and CAL/PM Documentation

• Effective prioritization and planning of ECO’s within Manufacturing Business Units and among sites.

• Assessment of Product/Process changes as to define an effective business prioritization as related to ECO’s process.

• Working with change leaders and other RA/QA representatives to support Impact Assessment, Risk Management and RAID as required.

• Maintaining a centralized and consistent presentation of ECO’s for the facility.

• Validation activities such as: Protocols, Execution, Deviations, and Reports review

• Reviewing/ Approving CAPA and Calibration Alerts Investigations.

• Quality System Management

• People Development

• Optimizing Unit Performance

• Vacations & Overtime Administration for Exempt

• Complies with the Quality Systems Regulations and the Occupational Health, Environmental & Safety policies and procedures.

Assists in:

• Design Review for new product development and transfer to Manufacturing
• Support during External Audits (FDA, ISO13485 and MDSAP)
• Product/Process changes Risk Assessment, DOE, Statistical Analysis
• Budget development and administration
• Analyzing new business opportunities scenarios
• Designing innovative alternatives

Actively participates in:

• Analysis of lenses for physical, dimensional and optical properties
• Experimental studies for new technology

Quality System Responsibilities

• Complies with the Quality System Regulation (QSR).
• Executes job responsibilities as established in the Standard Operating Procedures (SOP).
• Follows the documentation procedures.
• Completes training for the qualification and certification, as required, to execute the job.

Safety & Occupational Health Responsibilities

• Complies with Safety and Occupational Health Policy and procedures.
• Complies with Hazardous Communication program.
• Notifies immediately all accidents or incidents occurred in work area.
• Complies with the usage, inspection and maintenance of the personal protective equipment required, if applicable.

Travel:

Could be required to travel.

We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace

Qualifications

Knowledge, Skills and Abilities:

• Broad knowledge in Quality Systems regulations in the medical device / pharmaceutical industry.
• Thorough knowledge of project management
• Strong background in Change Control and Risk Management process
• Experience with metrology equipment
• Exposure to clinical studies requirements
• Knowledge on statistical analysis tools
• Proven Leadership skills
• High analytical capacity and level of professionalism and judgment to resolve problems
• Excellent oral/ technical written communication skills
• Fully bilingual

Experience:

• Six or more years of experience in Quality Engineering, preferably in Medical Device Industry
• Two (2) years of experience leading Quality or Technical Team.

Education:

• Bachelor’s degree in Sciences (Chemistry / Biology / Engineering)

• Service oriented

• Strategic thinking to drive solutions

• High degree of Innovation

• Proven knowledge in computer Microsoft (Excel, Word, PowerPoint) application and Quality Documentation Systems