Quality Engineer I

Purpose and role of job:

Responsible for the implementation, compliance, and maintenance of quality system operations.

Principal Accountabilities/ Responsibilities:

• Guides and supports the activities of technicians and specialists in the department
• Supervises the activities, performance review and disciplinary actions of any assigned staff.
• Understands and performs quality testing according to approved procedures.
• Regularly reviews quality data to identify opportunity for corrective & preventive action.
• Ensures that statistical methods are applied to testing, validation, sampling and inspection activities and quality investigations.
• Participates in and leads teams in work related improvement, new product development, cost savings, and other quality initiatives.
• Participates in internal quality audits.
• Oversees proper use and control of QA Department quality records.
• Acts as primary QA contact in supplier assessment and raw material qualification activities.
• Devises or revises procedures related to the Quality System.
• Ensures that all testing and measuring equipment is calibrated and maintained according to procedures.
• Participates in the calibration of specific tooling purchased by Nutek.
• Reports significant issues or developments identified during quality activities and provides recommended process improvements to management.
• Prepares and presents quality system information to team members.
• Performs laboratory tours and provides Quality System explanations to visitors.
• Observes all safety rules and uses the proper safety equipment at all times.
• Performs other duties as necessary when directed to do so.
• Follows necessary GMP, FDA, and ISO regulations.

Education and experience requirements:

• Bachelor’s degree in engineering discipline and two or more years in quality or manufacturing engineering, (or) Bachelor’s degree in a scientific/technical field with five or more years’ experience in quality or manufacturing engineering disciplines.
• Experience in statistics, procedure implementation, and quality auditing preferred.
• ASQ Certification or equivalent training (CQA or CQT required; CQE preferred).
• Familiarity with formal Quality System (ISO 9000, GMP/QSR, etc.)
• Strong communication skills.
• Experience with Microsoft Office (specifically Outlook & Excel)
• Demonstrated team leadership ability.