QA - LS, Enterprise Solutions, Automation & Digital Operations Leader

  • Malden, MA

Employment Type

: Full-Time

Industry

: Information Technology



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Role Summary:. This position is a key member of the Life Sciences Enterprise Solutions and A & D Quality Team responsible for supporting the effectiveness of the Quality Management System (QMS) and its operations in line with business strategy & customer needs. The role will support the QA Director, Enterprise Solutions and A & D on QMS process improvement plans and will lead the prompt resolution of customer complaints and the timely progression of investigations and corrective actions.. Essential Responsibilities:. This includes responsibility for monitoring & analysis of customer feedback to ensure Quality System improvements in line with developing requirements & focus areas. The role will be responsible for developing and managing a robust internal operations program & reporting to Senior leaders on the QMS KPI performance. This position will require a highly organized, analytical leader with strong people & influencing skills, who can effectively interact in a global environment. Responsible and accountable for reporting QMS compliance metric trends within the business and management review process, including MIT tool update, monthly operating review and QMR.. Drive timely customer complaint investigations & responses through regular cross functional complaint handling meetings with a global audience. Escalate as necessary to leadership to drive process rigor.. Meet bi-weekly with the Enterprise Solutions PMO to review Lessons Learned feedback from FlexFactory projects and identify appropriate actions to drive resolution using quality tools.. Lead regular CAPA board forums to address actions arising from continuous improvement activities & customer feedback/audits.. Support monthly DRB for Enterprise Solutions and A & D QMS documents and ensure compliance to QMS process.. Maintain Enterprise Solutions and A & D QMS training plan, which includes monthly updates for employee changes, document additions and revisions and generation of monthly reporting for leadership.. Support the internal audit plan for Enterprise Solutions and A & D.. Coordinate customer audits requested by Enterprise Solutions customers across multiple sites (as applicable) and host as appropriate based on audit content.. Work with the Westborough site QA team to incorporate updates as needed to the Quality plan on behalf of Enterprise Solutions and A & D business needs.. Provide coaching & mentoring across Enterprise Solutions and A & D in the use of the key quality tools and processes.. Support ad-hoc assignment based on business needs.. Qualifications/Requirements:. Bachelor's degree in engineering, quality, healthcare or Life Sciences field with minimum 5 years work experience in pharma or medical device Quality or Regulatory Assurance related field.. Demonstrated experience leading investigations & CAPAs (various complexities) in a compliant & timely manner.. Proven experience with problem solving tools and facilitation of Root Cause Analysis (RCA), as well as the ability to draw conclusions and provide recommendation.. Demonstrated ability to lead in a fast-paced technical environment, absorb technical information, review technical information and make technical decisions on data presented to support complaint resolution.. Solid experience in QMS establishment and maintenance, e.g. ISO9001, ISO13485. Hands-on experience with supporting or hosting ISO ISO9001/ISO13485 audits. Experience working with cross-functional, Global teams and facilitating teams to identify and implement solutions to complex problems.. Basic understanding of materials, properties, manufacturing processes, and product assembly.. Strong communication and presentation skills within all levels of the organization.. Understanding cultures across business organization as well as continents, such as Asia, USCAN & LATAM.. Availability for occasional business travel is required. Proficient with Microsoft tools; Word, Excel, PowerPoint, Project, Visio & ERP system.. Desired Characteristics:. Experience working within cGMP manufacturing environment. Strong learning agility and adaptability in new business environment. Product-specific knowledge in biomanufacturing Hardware & Software.. Advanced degree in Quality Assurance and/or Regulatory Affairs field.. Demonstrated program management or leadership skills.. Demonstrated experience in design controls, design verification and validation activities; production & process controls; Corrective & Preventive Action (CAPA), complaints & risk management; change control & product quality improvement.. Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies (i.e. 6 Sigma/DMAIC) & in-depth understanding of site level products & related processes. Demonstrated experience prioritizing conflicting demands in an extremely fast paced environment.. Excellent verbal, written, and presentation skills with the ability to communicate business issues clearly in English.. Excellent interpersonal, organizational, and influencing skills. About Us:. GE (NYSE:GE) drives the world forward by tackling its biggest challenges. By combining world-class engineering with software and analytics, GE helps the world work more efficiently, reliably, and safely. GE people are global, diverse and dedicated, operating with the highest integrity and passion to fulfill GE's mission and deliver for our customers. www.ge.com. GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, gender (including pregnancy), sexual orientation, gender identity or expression, age, disability, veteran status or any other characteristics protected by law.. Locations: United States; Massachusetts; Westborough. GE will only employ those who are legally authorized to work in the United States for this opening.. At GE, developing people is embedded in our culture and integral to our growth. Developing people is how we have succeeded across industr...
Associated topics: prevention, qa, quality, quality assurance, quality assurance lead, software quality, software quality assurance engineer, test, test engineer, tester


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