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.
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, KPIs 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.
Requirements: 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
This position is open to all candidates.