Careers at ThermoFisher Scientific

Key Responsibilities:

• Provide Quality input to Operations investigations, deviations, change controls, validation protocols, validation reports, SOPs, and in-process controls.
• Enable collaborative relationships between Operations and Quality with the overall focus of improving customer satisfaction.
• Assist Operations in troubleshooting process issues and facilitate inter-department team workshops in the resolution of process issues and quality problems.
• Work closely with Operations, R & D, Purchasing and Engineering to improve quality while reducing material scrap and costs.
• Drive quality management focus on productivity improvements throughout operations.
• Partner with Operations leadership to establish controls and inspection points to facilitate detection, correction, and prevention of nonconforming materials, parts, assemblies, and products.
• Serve as Quality Representative for all quality-related corrective/preventive actions within Operations.
• Assure that Operation's standards comply with division and departmental policies, national and international codes, and applicable safety requirements.
• Analyse trends and collaborate with Operations to investigate trends, conduct root cause analysis and implement corrective actions for processes and products.
• Participate and support internal / external audit program.

Minimum Requirements/Qualifications:

• Bachelor’s degree required in science discipline or related field
• A solid level of quality assurance experience in a medical device or pharmaceutical manufacturing environment.
• Strong background in process control and statistical techniques.
• Medical device, GMP, EU Regulation or ISO 13485 background.
• Demonstrated working knowledge of compliance, quality and scientific principles.
• Strong oral and written communication skills.
• Must be a self-starter who can take general concepts and direction and produce desirable results.
• Ability to prioritize multiple tasks functions effectively in a global, multi-site organization.
• Demonstrated ability to work effectively as a member of a cross-functional team.
• Strong working knowledge of quality related tools, such as structured problem solving, FMEA (Failure Mode and Effects Analysis), SPC (Statistical Process Control), DOE (Design of Experiments) and Six Sigma/PPI.
• Strong working knowledge of various computer software, such as SAP, as well as Microsoft Word, Excel and PowerPoint.
• Experience with lean manufacturing practices.
• Knowledge of qualification / validation (process, sterilization, cleaning, software) requirements.
• Perform independently without continual direction and exercise considerable latitude in determining technical objectives and solutions to complex problems.
• May be required to perform other related duties as required and/or assigned.

Essential Hiring Criteria:

• Excellent oral and written communication skills.
• Strong leadership skills with the ability to challenge, influence, and build consensus.
• Ability to work both independently and as a team member.
• Strong quality background and problem analysis and decision-making skills.