Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
About Thermo Fisher Scientific Inc.
When you join us at Thermo Fisher Scientific, you'll be part of a team that values curiosity, drive, and a passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we provide our people with the resources and opportunities to make meaningful contributions to the world. Our mission is to enable our customers to create a healthier, cleaner, and safer world. As a united team of over 100,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation, and Involvement - collaborating to accelerate research, solve intricate scientific challenges, drive technological innovation, and support patients in need.
Manager, QC
Position Summary:
The Manager of Quality Engineering drives day-to-day activities within and is responsible for the inspection of materials and environment. Providing the structure and tools vital to assure consistency and ongoing improvement of products and services, and compliance with customer and regulatory requirements.
Responsibilities:
Lead multiple teams of Quality Control inspectors and technicians who complete in-process, environmental, and finished product inspections (teams across multiple shifts)
Monitor product quality improvement to ensure execution of actions including any resulting customer communications/interactions.
Establish & maintain quality metrics to measure progress against goals related to product inspections, environmental monitoring, and other quality programs
Conduct and manage risk assessments associated with quality control procedures
Provide effective oversight of the execution of the Quality Plan, Risk Management activities, and all design-related activities during the product/system lifecycles
Interface directly with customers and internal groups
Apply continuous improvement skills and tools to prioritize and drive projects and improvements/standardization across the network, with a focus on enhancing Quality service levels and aligning with strategic objectives.
Mentor and support team members through their career development
Communicate effectively both within immediate quality teams and across network and division leadership
Help sites prepare for, and actively support, external audits (customer & regulatory) ensuring corrective/preventative actions are put in place to address identified non-conformances.
Provide leadership to the quality function vital to ensure that strategic and annual quality planning is integrated into strategic and operating plans with broad-based interpersonal involvement.
Ensures participation in New Product Development Process
Qualifications/Requirements:
Bachelor's degree (or higher) in an engineering or related science,
Minimum of 5 years of professional experience in a Science, Engineering, Quality, or Regulatory related role
Proven experience as a people manager (direct and indirect management)
Continuous improvement/lean processes and principles
Ability to manage & implement changes with minimal supervision, onsite and remotely at global locations.
Must be able to influence & negotiate with people & resolve issues.
Ability to make rational, objective and appropriate decisions relating to company & department requirements.
Ability to identify customer requirements and issues.
Develop realistic solutions to meet customer needs and solve problems.
Communicate recommendations and decisions across the organization.
Proven knowledge of Quality Management System tools, continuous improvement methodologies, and in-depth product understanding.
Demonstrated ability to effectively communicate non-conformances, risks, production, process controls, Corrective and Preventive Action (CAPA), and improvements
Ability to lead in a fast-paced technical environment, absorb technical information, review technical information, and make technical decisions.
ISO 13485 experience
Understanding of plastics- materials, properties, manufacturing processes, and product assembly.
Strong communication, presentation, and writing skills.
Proficient with Windows-based systems like Microsoft tools; Word, Excel, Power Point.
Desired Characteristics:
Working experience with cGMP requirements (21 CFR 820)
Ability to analyze and process data and draw the appropriate conclusions
Experience prioritizing conflicting demands
Excellent interpersonal, organizational, and influencing skills
Experience working with cross-functional teams and facilitating teams to identify and implement solutions to complex problems
