Quality Manager

Are you an experienced Quality Manager within the medical device industry?

Summary:

Manages total quality programs, policies, and initiatives. Responsible for identifying, analyzing, and developing improvements in productivity, quality, client relationships, and customer service. Familiar with a variety of the field's concepts, practices, and procedures. Relies on experience and judgment to plan and accomplish goals. Performs a variety of complicated tasks. Leads and directs the work of others in the quality department.

Responsibilities:

• Manage QMS / ISO 13485:2016 Registration


• Coordinate and lead internal audits


• Investigate and correct customer issues and complaints as relates to quality


• Create, develop and implement inspection criteria and procedures


• Calculate and monitor non-conformances and trends to help determine process improvements and enter into ERP system


• Define and create company policies and QMS procedures, and work instructions


• Perform vendor audits


• Calculate and maintain vendor scorecards


• Work with machining vendors on inspection and processing of outsourced product to reduce risk.


• Work with manufacturing vendors for cost savings and process repeatability


• Lead the Material Review Board (MRB)


• Process all customer returns


• Define rework processes w MRB


• Establish and document product packaging / Special Packaging and Labeling


• GR&R / Statistics / SPC


• Process validation (IQ/OQ/PQ)


• Review and complete customer surveys


• Create PFMEAS / maintain PFMEAS and updated RPN numbers


• PPAP / Control Plans Work with customer QE as needed


• Risk management


• Program CMM / Train CMM programmers


• Print / GD&T Interpretation and training


• Gage design


• Perform Root Cause and Corrective Actions


• Train personnel in RCCA


• Create First Piece, In-Process, Receiving and Final Inspection sheets


• Determine process tolerance for manufacturing (Pre-Coat, Pre-Heat Treat, etc.)


• Support, monitor and continually improve all quality systems


• Maintain, monitor, and report on performance against Quality Objectives


• Management Representative during audits Customer / ISO / FDA


• Design, develop and implement quality control training programs


• Participate in the development of the companys strategic planning, vision, mission and values and desired culture


• Provide good feedback and promote good communication


• Abide by and support all quality system requirements


• Lead and direct the quality department


• Perform other duties as assigned

• Document control and retention process


• ECO process


• Calibration process


• Quality manual, policy, and objectives


• Internal audit process


• Continuous improvement process


• Data analysis process


• CAPA process


• RMA process


• Product identification & traceability process


• Non-conforming material process


• Supplier qualification

Education and/or Experience:

• Bachelors degree or equivalent


• Previous experience required