Job Title:Operations - Technical Quality Manager
When you join us at Thermo Fisher Scientific, you'll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of over $28 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
This role will be based at our Auburn, AL facility.
How will you make an impact?
We are looking for a self-driven and resourceful QA leader with up-to-date knowledge, and demonstrated experience to lead Quality Control activities and to manage Technical Quality processes to ensure compliance with ISO 9001:2015 and 21 CFR 820.
Our customers are world leading pharma and diagnostics companies who have selected our products to enhance their services. We take great pride in ensuring total customer satisfaction, in large part with great product quality.
What will you do?
- Assist Quality Assurance Manager in establishing, implementing, maintaining, and improving the site quality management system.
- Coordinates resources to ensure prompt, comprehensive incoming and in-process in support of product release, handling of OOS and follow up to ensure continuity of service.
- Ensure timely release of products, handling of Nonconforming products and planned deviations related to production, follow up on NCR (Non Conformance Report) and CAPA.
- Drive standardization and optimization of technical processes e.g. DMR, Control Plans, risk management, calibration metrology, etc.
- Plan, develop and approve documentation for process, test method, and software validation.
- Provide support with data analysis, statistical rationale and sample plans.
- Lead investigations and root cause analysis for complex problems.
- Management of the Calibration function for Quality-related processes and manages to ensure the right prioritization is performed to support operations.
- Effectively use continuous improvement skills and tools to prioritize and drive projects and improvements/standardization across the network to improve Quality service levels, reduce costs, and align with strategic objectives.
- Consistently promote high standards through personal example.
- Help sites prepare for, and actively support, external audits (customer & regulatory) ensuring corrective/preventative actions are put in place to address identified non-conformances.
- Set department objectives/KPI's and review and assess ongoing performance of direct reports.
- People management to ensure a high performing, efficient team with focus on job satisfaction and people development.
- Coach and support team members through their technical and professional development.
How will you get here?
- Bachelor's degree (or higher) in an engineering, science, operations or related field
- 5+years of professional experience in Quality Engineering, Operations Quality or Quality Manager role
- 3+ years ofexperience as a peoplemanager
- Experience working in a GMP environment, such as Medical Device industry or plastic consumables
- Experience at effectively communicating complaints, risks, production, process controls, Corrective and Preventive Action (CAPA) and improvements
- Experience prioritizing conflicting demands
- Experience working with cross-functional teams and facilitating teams to identify and implement solutions to complex problems
- ASQ Certified Quality Engineer is preferred or similar certification
- Working experience with TrackWise, SAP, Documentum
- Six Sigma and Lean Manufacturing experience
Knowledge, Skills, Abilities:
- Strong problem solving and analytical skills and developed understanding of risk management
- 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 needs and issues.
- Develop realistic solutions to meet customer needs and solve problems.
- Communicate recommendation and decisions across the organization.
- Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies, in-depth understanding of products and processes
- Demonstrated ability to lead in a fast-paced technical environment, absorb technical information, review technical information and make technical decisions.
- Strong communication and writing skills.
- Excellent communication and presentation skills. Proficient with Microsoft tools; Word, Excel, Power Point.
- Working experience with cGMP requirements (21 CFR 820) and MDR
- Ability to analyze and process data and draw the appropriate conclusions.
- Excellent interpersonal, organizational, and influencing skills.
- Ability to analyze and process data, and draw the appropriate conclusions.