Title:  Manufacturing Quality Team Leader

Job Summary

In this role, the Sr. Engineer, Manufacturing Quality, Team Leader provides quality and GMP oversight to the medical device production processes performed at the West IL Contract Manufacturing sites, while working within a multi-functional environment. The Sr. Engineer, Manufacturing Quality, Team Leader will lead projects and tasks to ensure products and processes meet quality standards consistent with internal procedures and acceptance criteria, while meeting applicable regulatory requirements.  Additionally, this role will identify and implement improvements within the production processes.  The Sr. Manufacturing Quality Team Leader will be a strong advocate for product, process, and system quality at all stages post design transfer. Provide support and guidance to Engineering and Operations.

The Sr. Engineer, Manufacturing Quality, Team Leader leads the routine shopfloor inspections at the CM sites and leads Quality Engineers who are auditing the production processes at the CM. He/she will also be leading personnel responsible for production related processes such as investigation of Nonconformances with production related material/product/devices, initiating rework, special work instructions and also support continuance improvement of product, process and QMS. He/she will perform all duties associated with the auditing and documentation of compliance related items against GMP and ISO standards for West and its subcontractors.  The Sr. Engineer, Manufacturing Quality, Team Leader will also execute transactions in relevant GMP systems (MasterControl, Share Point, SAP) and other relevant quality functions as applicable including site audit support. 

Essential Duties and Responsibilities

• Exhibit a strong “quality first” mentality and ensure that product and quality are held to the highest standard.
• Leading Manufacturing Quality Engineers in the day-to-day operations which includes monitoring the employee performance and tasks handling, training and objectives prioritization according to the organizational goals.
• Lead the Contract Manufacturing routine GMP presence on the shopfloor – leading Quality Engineers’ presence on the shopfloor, perform onsite inspections at the CM manufacturing, warehouses, and cleanrooms, verify compliance with West’s production, inspection, and maintenance procedures. Leading engineers who identify, record, and investigate nonconformities (NCM) and perform follow up on action items.
• Lead process improvements related to the quality areas in production, such as reduction of COPQ (Cost of Poor Quality), Data Integrity, streamline of production and in process testing, etc.
• Lead and approve failure investigations for deviations and nonconformities in production and analysis reports issued by Manufacturing Quality Engineers.
• Leading Manufacturing Quality Eng. responsible for the CMs training processes according to applicable procedures.
• Responsible to review and approve NCMR- responsible to define products and subassemblies disposition and follow up activities.
• Responsible for approving special production processes such as sorting, rework in production, pilots.
• And all other related process as define in the Job Description and comapny requirements

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

• B.Sc. in Engineering or Science required.

Work Experience

• Minimum 5 years in Quality Assurance/Quality Control in a Medical Device/Pharma industry production environment
• Relevant work history and/or experience may be considered in lieu of degree/years of experience
• At least 2 years as a team leader- a plus
• CQE- an advantage
• Courses related to quality management system in the medical device industry
• In-depth and strong knowledge of Medical Device manufacturing processes- mold injection/ assembly/ primary packaging
• Must have effective problem solving and interpersonal skills
• Ability to work independently, multi-task and thrive in fast-paced environment
• Problem solving including root cause failure analysis methods
• Internal auditor- a plus
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Able to comply with the company’s safety policy at all times.

Preferred Knowledge, Skills and Abilities

• English - reading, writing and verbally
• knowledge and ability in Excel and PowerPoint
• Ability to work under pressure
• Good interrelation skills
• Technical ability
• Creativity
• High Learning ability
• Organized 
• written and verbal communication skills
• ability to prioritize

License and Certifications

• NCM approval & closure
• Approval of raw material
• Approval of QA records
• Approver of Special Instructions or Rework Instructions.
• DHR approval
• Perform training to sub-contractors.
• Stop/ renew production approval
• Approval of calibration certificates

Travel Requirements

Physical Requirements

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.