He/she will monitor and control the daily activities of quality inspection, testing, documentation review.Carry out QC tasks/ inspections when required, to support the team.
Essential Duties and Responsibilities
Supervise shift personnel in the quality control department consistent with high safety and quality standards.
Troubleshoot problems arising on the shop floor in conjunction with quality standards with the appropriate engineering support from Quality Engineering functions
Maintain close observation of quality requirements to keep quality management informed of status and, when needed, initiate the necessary steps to conform to schedule / staffing requirements.
Promote and support site initiatives including quality safety programs, lean initiatives, training programs, and consistently interpret and apply all policies, practices and procedures among plant team members.
Recommend and implement measures to motivate team members and to encourage employees to recommend ways to improve process, quality, safety and efficiency.
Routinely evaluate team member performance and identify training needs. Coach and counsel team members for performance, attendance and behavior. Participate in the resolution of team members relations issues.
Review and approve work time in the appropriate timekeeping system. Maintain and verify accuracy of the hours each team member has worked.
Works independently to identify Quality issues, initiate nonconformance reports, and recommend corrective actions
Determine product acceptability by performing various types of inspections and measurements utilizing varying laboratory equipment and taking care of valid calibration (internal and external)
Create, utilize, and maintain testing result forms
Develop sampling plans and activities, as required
Authoring of quality notifications such as deviations and OOS (visual and dimensional)
Support review of batch production records and perform review, approval, and release of product and materials within the inventory management/ERP system
Ensures compliance with quality system documents, cGMPs, ISO standards and FDA regulations.
Work with technical staff in performing root cause failure analysis and implementing corrective and preventive actions to eliminate recurrence.
Manage the team’s performance, conduct performance 1 to 1’s, support recruitment, training and development plans while addressing any issues that arise in a timely manner
Liaise with internal and external customers and other departments as appropriate.
Ensure that the QC inspection conducted are performed according to relevant procedures and data reported in compliance with data integrity principles
Act as a central point of communication for all departments in respect to product quality issues on the shop floor and ensure that these are escaladed appropriately.
Other duties as assigned
Additional Responsibilities
Participate in special project teams as assigned.
Performs other duties as assigned based on business needs.
Conforms with and abides by all laws, regulations, safety rules, policies, and work procedures, and all instructions.
Exhibits regular, reliable, punctual and predictable attendance.
Education
Associate's Degree Associate's Degree in Technical or Engineering required or
Bachelor's Degree Degree in Technical or Engineering preferred
Work Experience
Minimum 5 years Previous experience in Quality Assurance/Quality Control required and
Experience in FDA regulated environment, pertinent to ISO 13485 preferred and
Preferred Knowledge, Skills and Abilities
Must be familiar and proficient with computers and various software programs such as Microsoft Word, Microsoft Excel, Master-control, SAP
Able to comply with the company’s safety policy at all times
Able to comply with the company’s quality policy at all times.
Support and contribute to Lean Sigma programs and activities towards delivery of the set target
Leadership experience in leading teams of 10-15 people preferred
Physical Requirements
Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.
Additional Requirements
Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays, or unexpected events.
Maintain high attention to detail, accuracy, and overall quality of work.
Effectively communicate and interface with various levels internally and with customers.
Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
Performing the duties of this job involves the employee walking, standing on concrete floor, sitting for extended periods, lifting of cartons, containers, or bags of product, using hands and fingers to touch or feel materials or products, and listening for audible tones of equipment. This requires that the individual have normal hearing ability. The employee must be able to maintain concentration and visual acuity on tasks for extended periods.
The employee must perform visual inspection of product, color standards, raw materials, and graphics. Specific vision abilities required to perform these tasks include close vision, color vision, peripheral vision, depth perception, and the ability to focus when viewing items through magnification. Required to work 40 hours a week and some overtime.