First Quality

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.

First Quality is committed to protecting information under the care of First Quality Enterprises commensurate with leading industry standards and applicable regulations. As such, First Quality provides at least annual training regarding data privacy and security to employees who, as a result of their role specifications, may come in to contact with sensitive data.

First Quality is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, sexual orientation, gender identification, or protected Veteran status.