Supervises and coordinates activities of quality inspectors engaged in inspecting incoming materials, material review board, work in-process electronic components, and finished assemblies to adherence to company quality standards, ISO 13845, and customer specifications.
Plan daily work schedules, determine priorities, allocates work assignments in order to support production.
Manage resolution of manufacturing caused customer complaints.
Facilitate assignment and completion of CAPA’s (Corrective Actions/Preventive Actions).
Perform failure analyses, root cause analysis and corrective action follow-up.
Execute internal audits on QMS and ISO 13485 standards.
Review and approve deviations to raw material, process and product requirements.
Oversee training of Quality Inspectors and Quality Training of production operators.
Apply working knowledge and interpretation of corporate and plant policies and procedures.
Handle administrative activities such as time reporting, attendance control, vacation planning and overtime, etc.
Evaluate employee performance and provides necessary feedback.
Focus on improving process and product understanding, utilizing Lean Six Sigma methodologies and nurturing an environment supportive of continuous improvement.
Model and enforce all 13485 rules, required policies and procedures.
Provide effective communication to employees to encourage teamwork.
Ensures all product returns are handled appropriately and inspection reports are adequate and completed in a timely manner.
Reviews all in-process audit documentation to ensure actions taken are appropriate and provide data to manufacturing.
Ensures all devise history records are reviewed and completed accurately.
Ensures all non-conforming material reports are provided to MRB for disposition in a timely manner.
Prepare quality reports, including the customer returns, initial and final response time reports, open corrective action report, supplier quality reports and customer specific reports as required.
Assist Engineering and other groups in developing quality and performance standards for products manufactured by the facility.
Minimum of five years of experience working in an electronic medical device manufacturing setting. Combined supervisory and/or team lead experience. Good organization skills. 3-5 Years of progressively responsible experience in manufacturing environment including: Quality assurance process control and documentation, SPC, problem solving, and metrology. Excellent oral and written communication skills. Good PC skills, experience in Word, Excel, Access, Windows environments helpful.
Please include Quality Supervisor in the subject line of your reply. Please send resume with salary history to email@example.com in Microsoft Word format. No third party resumes or telephone calls. Equal Opportunity Employer. M/F/H/V