Title:  Team Leader, Quality Operations

Job Summary

In this onsite role, the Team Leader Quality Operations  leads a team of Quality Engineers that support manufacturing processes and projects, as well as provide quality oversight to the Engineering department within a multi-functional team environment for medical devices. This Team Leader will lead QEs, projects and tasks, from product inception through commercial product and play an active role to ensure products meet quality standards consistent with internal procedures and acceptance criteria, while meeting all applicable regulatory requirements. Additionally, this role will identify and implement improvements within the Quality Management System. The Senior Quality Engineer will be a strong advocate for product, process, and system quality at all stages of manufacturing processes.

The STeam Leader Quality Operations will support continual improvement of products, processes or QMS and perform all duties associated with the auditing and documentation of compliance related items against GMP and ISO standards for West and its suppliers. The Senior QE, Operations - Team Leader will also execute transactions in relevant GMP systems (Master Control, SAP, Share Point) and other relevant quality functions as applicable including site audit support. At the discretion of the QE Manager, the Sr. QE might also require to support the design control process in terms of product development DHF documentation.

Essential Duties and Responsibilities

• Exhibit a strong “quality first” mentality and ensure that products, processes and quality are held to the highest standard, adhere to all company policies, KPI’s and follow all safety rules and safety procedures
• Lead QEs’ daily activities, provide support, guidance, set objectives, monitor performance, and follow-ups as required.
• Provide guidance on documentation structures and format to ensure compliance to procedures, relevant regulations and standards.
• Responsible to provide support to manufacturing related processes, such as (but not limited to) approval of equipment qualification, process risk management and pFMEA, and process validation documents (URS, IQ, OQ, PQ, etc.), and responsible to review, and approve product development DHF documentation (product specifications, design verification & validation activities, FMEA risk documents, test methods, protocols, reports, OOSs, product transfer to operations, etc.) in relation to medical devices.
• Lead the Quality involvement in development and maintenance of product and hazard analysis in accordance with West policies and procedures.
• Provide Quality oversight of qualification/validation/review and approval of documentation and reports/design controls activities to other QEs
• Work cross-functionally with individuals and project or extended teams to provide guidance and ensure success of projects.
• Responsible to review and approve process development QMS procedures and work instructions and support QMS activities as required. 
• Liaison with company and customers on Quality matters related to engineering projects.
• Support routine sterilization validation monitoring activities.

Education

• B.Sc. in Engineering or Science required
• Relevant work history and/or experience may be considered in lieu of degree

Work Experience

• Minimum 5 years of experience in Medical Device / Pharma industry as Quality Engineer / Validation Engineer
• Experience in Equipment Validation, Process Validation, Risk Management, Change Control Process
• Strong working knowledge of quality systems such as ISO 13485, 21 CFR 820, ISO 14971, MDSAP

Preferred Knowledge, Skills and Abilities

• Excellent written and oral communication skills
• Excellent critical reading and writing skills
• Must have effective problem solving including root cause failure analysis methods
• Ability to work independently, multi-task and thrive in fast-paced environment
• Problem solving including root cause failure analysis methods
• Proficient in statistical software, Windows OS, Microsoft Office Suite including Word, Excel, and Power Point
• Management experience – an advantage

Travel Requirements