Job Summary:
The primary purpose of this position is to lead a team of Quality Control Inspectors in a production environment, overseeing the quality control process from raw materials to finished medical devices.
Responsibilities:
* Ensure quality control personnel comply with the quality system requirements.
* Prepare or review SOPs and manufacturing/quality control instructions.
* Maintain cleanliness standards in manufacturing areas to control product bio burden.
* Relay changes to relevant procedures/instructions to affected teams.
* Review and provide training on quality control processes as needed.
* Monitor employee performance and conduct performance appraisals.
* Maintain communication channels with production teams and other departments.
* Work closely with other departments to meet delivery requirements.
* Investigate customer complaints, CAPAs, and determine root cause.
* Monitor rejects from quality control processes and dispose through MRB.
* Evaluate business matters against Cook's Code of Conduct.
Qualifications:
* Bachelor's degree in Manufacturing Engineering or related field (preferable).
* Minimum 5 years of supervisory experience (desirable).
* Strong communication and interpersonal skills.
* Knowledge of ISO13485/FDA practices and GMP or similar regulated industry standards.
* Lean Manufacturing knowledge (desirable).
* Proficient computer skills, including Microsoft Office.
* Excellent organizational and team building skills.
* High self-motivation.
* Availability for travel on company business.