Quality Assurance Manager - Millersburg, PA

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Warehouse

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

How will you make an impact?
 

The QA Manager leads day-to-day quality operations and is accountable for achieving quality objectives while ensuring compliance with industry standards. This role determines, organizes, and deploys the necessary resources to meet defined quality requirements and ensures adherence to corporate, regulatory, and quality expectations. The QA Manager also ensures customer requirements are met or exceeded by providing the structure, processes, and tools needed to drive consistency, continuous improvement, and compliance across products and services.

What will you do?

• Lead a team of QA specialists responsible release of manufacturing lots, document control processes, external and internal audits, deviation management and CAPA, and change control processes.
• Monitor product quality improvement to ensure execution of actions including any resulting customer communications/interactions.
• Establish & maintain quality metrics to measure progress against goals
• Execute & maintain risk assessments related to QA processes
• Provide effective oversight of the execution of the site Quality Improvement Plan, Risk Management activities and of all design related activities during the product/system lifecycles
• Interface directly with customers and internal groups
• 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.
• Coach and support team members through their technical and professional development.
• Communicate effectively across all site functions and quality teams, as well as with network and divisional leadership, to drive alignment and a strong site quality culture.
• 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 necessary to ensure that strategic and annual quality planning is integrated into strategic and operating plans with broad-based organizational involvement.

How will you get here?
 

Education:

• Bachelor’s degree (or higher) in an engineering, science, operations or related field

Experience:

• Minimum of 8 years of professional experience in an Engineering, Quality or Operations related role
• Minimum of 3 year experience as people manager

Knowledge, Skills, Abilities

• Experience related to continuous improvement/lean processes
• 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 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
• Experience at effectively communicating complaints, risks, production, process controls, Corrective and Preventive Action (CAPA) and improvements
• Demonstrated ability to lead in a fast-paced technical environment, absorb technical information, review technical information and make technical decisions.
• Experience working with ISO 13485
• Understanding of plastics- materials, properties, manufacturing processes, and product assembly.
• 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)
• Ability to analyze and process data and draw the appropriate conclusions.
• Experience prioritizing conflicting demands
• Excellent interpersonal, organizational, and influencing skills
• Ability to analyze and process data, and draw the appropriate conclusions
• Experience working with cross-functional teams and facilitating teams to identify and implement solutions to complex problems