Job Summary

In this role, you will monitor and control the daily activities of quality inspections of incoming, in-process, final, and batch record review and release. In his position, you will manage the Quality Control team to ensure inspection process is executed in a proper and timely manner by ensuring procedures are followed and improved as part of a continuous improvement mindset. 

Essential Duties and Responsibilities

• Provides direct supervision, resolves personnel issues, conducts performance evaluations, and performs managerial discipline, as necessary.

• Direct reports include quality control supervisors

• Leads and directs the Incoming Inspection, In-Process Inspection, and Batch Release teams with a positive and patient attitude.

   

• Maintains and instills in others a “quality at the source” mentality as it pertains to all aspects of manufacturing, including documentation, training, and other functions related to production.

• Maintains and instills in others an “immediate audit readiness” mentality so that records and actions are executed in a way that ensures their accuracy, legibility, and immediate retrievability.

   

• Ensures compliance with quality system documents, cGMPs, ISO standards and FDA regulations.

   

• Schedule and prioritize quality inspection, testing, and batch record review and release to support Operations and release of product.

   

• Identifies and develops opportunities to improve existing processes and procedures

   

• Support quality assurance improvement activities by evaluating products, processes or materials in order to develop control or improvement strategies intended to improve the customer’s experience.

   

• Work with technical staff in performing root cause failure analysis and implementing corrective and preventive actions to eliminate recurrence.

   

• Manage the verbal communications and visual checks of work activity to ensure quality requirements are met. Ensure proper corrective actions, discrepancy reports and follow up activities are accomplished.

   

• Reviews documentation and records for accuracy. Determines if product is impacted, can be released, or if Non-Conformance Report is required.

   

• Manages the development of documentation and procedures during the qualification of new equipment/inspection methods.

   

• Exhibits regular, reliable, punctual and predictable attendance.

   

• Creates, prepares, implements and improves Quality Control KPIs metrics.

   

• Determines/sets Goals and Objectives for the Quality control organization and training programs for team's development purposes.

   

• Supports investigations related to Non conformances, Audit observations, CAPAs, or Issue Reviews as needed.

   

• Ensures equipment is up to date on Preventive maintenance and calibration activities.

   

• Maintains the QC area well organized with a 5S mindset.

   

• 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 8 years previous experience in Quality Control required and
• Experience in FDA regulated environment, pertinent to ISO 15378 preferred

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
• Metrology Equipment experience
• Leadership experience in leading teams preferred

Travel Requirements

Physical Requirements

Additional Requirements

• This job requires decision making based on data analysis
• Must be able to generate, express, and exchange new ideas
• Must be able to understand direction and adhere to established procedures
• Must be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read & write, speak in front of groups, express & exchange ideas, understand direction and adhere to procedures
• Organizational skills will enable planning, prioritization & achievement of goals especially of importance for the successful execution of related activities
• Read and interpret data, information and documents
• Must maintain the ability to work well with others in a variety of situations
• Must be able to multi-task, work under time constraints, problem solve, and prioritize
• Ability to make independent and sound judgments
• Observe and interpret situations, analyze and solve problemsAdaptable to changes in the work environment, manage competing demands and deal with frequent change, delays, or unexpected events.

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