The Quality Manager is responsible for fostering a quality culture within the organization and overseeing the day-to-day quality activities in manufacturing, inspection and assembly operations. Implement and monitor quality metrics to ensure quality goals are achieved and that all process controls are in place to achieve the highest level of product quality.
- Serve as a quality control resource for problem identification, resolution, and continuous improvement.
- Help establish and implement quality metrics (process capability, control charts, measurement quality) for monitoring the effectiveness of the QMS.
- Supports the quality management system through daily work and audit activity.
- Develop and implement procedures for process control, process improvement, testing and inspection.
- Help educate and train employees to proactively identify, analyze, track, control, mitigate and report issues.
- Perform root-cause analysis and other problem-solving activities to identify effective corrective actions and process improvements.
- Assist quality inspectors and manufacturing in problem solving as needed.
- Establish collection and analysis systems of statistical data to predict trends that will affect improvement of product quality.
- Complete quality assurance operational requirements by scheduling and assigning quality inspectors and following up on work results
- Maintain strong relationships with leaders across the organization related to quality and compliance plan issues.
- Provide guidance and technical expertise to departments and projects that concern quality.
- Oversee quality-related activities and tasks to maintain excellence in product transfer from design to manufacturing
- Follows all company policies and procedures
- All other reasonable duties, as assigned.
Education & Experience Requirements:
- 5 – 10 medical device experience in a quality engineering or supervisory role, orthopedic device experience a plus.
- College degree (mechanical or biomechanical engineering desirable).
- Proficient with measuring using optical and metrology equipment, micrometers, gages, and other hand instruments.
- Able to interpret drawings to develop test methods and perform Gage R&R.
- Solidworks EPDM experience a plus.
- Statistical process control.
- Ability to work sitting for extended periods.
- Ability to lift up to 20 lbs.
- The employee might be frequently required to climb stairs, kneel, or crouch, in accordance with job duties.