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
Areas & Procedures Owned:
- 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