Description:
ESSENTIAL DUTIES:
- Ensure compliance to internal ISO requirements.
- Lead weekly quality meetings and problem-solving activities with production and engineering teams.
- Ensure daily data collection of inspections with quality tech. and improve first pass yield %.
- Conduct review of testing process/procedures and implement corrections and improve efficiency.
- Work in team environment to address customer issues for out of box failures.
- Lead and assist in root cause analysis and facilitate the corrective/preventative action of quality issues.
- Review weekly non-conforming material, disposition, implement corrective and preventative actions, and communicate with suppliers, production, and Quality Manager regarding action and improvement.
- Administer and update Quality information system activities for CAR’s, calibration, and document control.
- Work with 1-2 suppliers to improve overall product quality and performance (limited travel if applicable).
KNOWLEDGE, SKILLS & EXPERIENCE:
- A bachelor’s degree in an engineering discipline is required, as is 2-4 years of experience in manufacturing environment working with quality/process improvements. Medical equipment experience is desired.
- Ability to understand controls and mechanical designs is desired.
- Excellent written and verbal communication skills and the ability to work well with people at all levels are essential. Must have strong organizational, analytical, problem-solving skills.
- Experience with ISO 9001:2015/13485:2016 and other related business standards is desired.
- Experience with 8D methodology, Control Plans and PFMEA desired.
- Candidate must have ability to effectively handle multiple projects simultaneously.
- Ability to work with minimal supervision and possess a willingness to make autonomous decisions.
- Ability to create and drive change and effectively communicate throughout the organization.
- Works with integrity and respect displaying a high degree of tact and diplomacy.
- Must be familiar with various measuring devices and analyzing information.