Senior Quality Engineer

Senior Quality Engineer - Milpitas, California (Bay Area)
50% Travel - (Canada, South Carolina, Missouri, India, Taiwan, Mexico)
Would love someone who is close to the office. At minimum needs to be West Coast.  
Role Summary
This Senior Quality Engineer opportunity offers an enriched and broad scope that involves working collaboratively with teams in the supply chain, quality, engineering, and project management. You will provide day-to-day management to drive the delivery of the business’ Quality standards and controls. This individual will be responsible for providing operational management to develop, implement, and manage Quality Systems compliant with regulatory requirements, lead cross-functional teams, lead the process on design controls related to quality and process, risk management activities, complaint handling, CAPA, document control, supplier qualification and management, and auditing.
Responsibilities:

• Member of the senior leadership team (SLT) for the company site. In this role, you will provide management of site quality and compliance.
• Provide expertise and management of the QMS system for the company site in compliance with the latest applicable needs and regulations.
• Maintain and continually improve the Quality Management System.
• Manage QA functions including document control, protocol writing, complaint handling, CAPA, supplier quality assurance program, and all day-to-day quality activities To start with, there will be a particular focus on setting up a robust supplier quality assurance program.
• Management representative responsible for leading management reviews, company-wide communications on quality system status and primary interface for external audits.
• Work closely with various functions within the company to create documents and systems.
• Ensure compliance with the quality system, as well as any applicable regulatory requirements.
• Lead the QA function by developing, communicating, and building consensus for goals and programs that support company objectives.
• Support group governance by active engagement and contribution to the group quality requirements and projects.
• Maintain up-to-date knowledge of applicable global Biopharma regulations and standard including but not limited to ASME-BPE, PED, BPOG and USP.
• Provide ongoing support for sustainment of electronic systems, records, design of operational reports and dashboards and processes.
• Use statistical analysis and quality techniques to collate, trend and analyze quality KPIs
• Assist line manager with future Watson-Marlow group projects and other duties where necessary

Qualifications:

• Bachelor’s degree in an applicable science or engineering discipline, or equivalent experience
• Strong hands-on experience with project management and collaboration on complex projects
• Highly effective interpersonal, verbal, and written communication and organizational skills, with a self-motivated, achievement orientation
• Understanding of current quality-assurance risk-based techniques and their impact on internal procedures, product fit, form and function
• Verification & validation experience for product and process in manufacturing
• Experience with quality systems and/or pharmaceutical industry regulations which could include areas such as: ISO 13485, 21 CFR 820, AS9100, NADCAP, ASME-BPE or others
• Experience working in a QA department including document control, complaint handling, CAPA, supplier quality assurance program and all day-to-day quality activities
• Demonstrated experience collaborating with and leading cross functional teams to identify and resolve quality related issues in a timely and effective manner.
• Ability to drive functional, technical, and operational excellence
• Strong analytical skills including: Six Sigma Green or Black Belt certification preferred or equivalent skills and experience
• Certification by an accredited body in Quality Management or an associate discipline is beneficial